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2025-05-01 00:00:00
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11242_11261_R
|
Initial treatment - dose titration
|
AUTHORITY_REQUIRED
| 11,261 | 11,242 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment - dose titration</p><br/><p>Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND</p> <p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align="justify">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align="justify">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align="justify">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align="justify">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align="justify">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align="justify">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pulmonary arterial hypertension (PAH)</p><br/><p>Initial treatment - dose titration</p><br/><p>Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND</p> <p>Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or</p> <p>Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND</p> <p>The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND</p> <p>The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as ''triple therapy''); or</p> <p>The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as ''dual therapy in lieu of triple therapy''); AND</p> <p>The treatment must not be as monotherapy; AND</p> <p>Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND</p> <p>Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.</p> <p align="justify">A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.</p> <p align="justify">For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.</p> <p align="justify">PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.</p> <p align="justify">PAH (WHO Group 1 pulmonary hypertension) is defined as follows:</p><p align="justify">(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or</p><p align="justify">(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.</p> <p align="justify">PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:</p><ul><li>Idiopathic PAH</li><li>Heritable PAH<br/><ul><li>BMPR2 mutation</li><li>ALK-1, ENG, SMAD9, CAV1, KCNK3 mutations</li><li>Other mutations</li></ul></li><li>Drugs and toxins induced PAH</li><li>PAH associated with:<br/><ul><li>Connective tissue disease</li><li>Human immunodeficiency virus (HIV) infection</li><li>Portal hypertension</li><li>Congenital heart disease</li><li>Schistosomiasis</li></ul></li></ul>
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N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-02-01
| 3,671 |
11248_9073_R
|
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
|
AUTHORITY_REQUIRED
| 9,073 | 11,248 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
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N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-02-01
| 3,671 |
11250_4368_R
|
Initial treatment for up to 3 months
|
AUTHORITY_REQUIRED
| 4,368 | 11,250 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align="justify">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align="justify">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align="justify">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align="justify">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align="justify">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align="justify">The date of birth of the patient must be included in the authority application.</p><p/>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Eosinophilic oesophagitis</p><br/><p>Initial treatment for up to 3 months</p><br/><p>Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist; AND</p> <p>Patient must require an amino acid based formula as a component of a dietary elimination program; AND</p> <p>Patient must be 18 years of age or less.</p> <p/><p align="justify">Treatment with oral steroids should not be commenced during the period of initial treatment.</p><p/> <p align="justify">Eosinophilic oesophagitis is demonstrated by the following criteria:</p><p align="justify">(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and</p><p align="justify">(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and</p><p align="justify">(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.</p> <p/><p align="justify">The date of birth of the patient must be included in the authority application.</p><p/> <p/><p align="justify">Authorities for increased maximum quantities, up to a maximum of 52, may be authorised.</p><p/>
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N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-02-01
| 3,671 |
11268_9155_R
|
Initial treatment - Initial 1 (new patient)
|
AUTHORITY_REQUIRED
| 9,155 | 11,268 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p>Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 3 months treatment with methotrexate and 3 months treatment with sulfasalazine or leflunomide can be found on the Department of Human Services website (www.humanservices.gov.au)</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-02-01
| 3,671 |
11271_8892_R
|
Continuing treatment, Face, hand, foot
|
AUTHORITY_REQUIRED
| 8,892 | 11,271 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-02-01
| 3,671 |
11272_4599_R
| null |
AUTHORITY_REQUIRED
| 4,599 | 11,272 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Homocystinuria</p><br/><p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p> <p align="justify">The name of the specialist must be included in the authority application.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Homocystinuria</p><br/><p>The treatment must be as adjunctive therapy to current standard care; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p> <p align="justify">The name of the specialist must be included in the authority application.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-02-01
| 3,671 |
11293_6395_R
| null |
AUTHORITY_REQUIRED
| 6,395 | 11,293 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p><br/><p>The condition must be proximal or extensive (greater than 80% nail involvement); AND</p> <p>Patient must have failed to respond to topical treatment; AND</p> <p>The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; or</p> <p>The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.</p> <p>The date of the pathology report must be provided at the time of application and must not be more than 12 months old</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Onychomycosis</p><br/><p>The condition must be proximal or extensive (greater than 80% nail involvement); AND</p> <p>Patient must have failed to respond to topical treatment; AND</p> <p>The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; or</p> <p>The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.</p> <p>The date of the pathology report must be provided at the time of application and must not be more than 12 months old</p> <p>No increase in the maximum quantity or number of units may be authorised.</p> <p>No increase in the maximum number of repeats may be authorised.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-02-01
| 3,671 |
11297_5341_R
|
Initial treatment
|
AUTHORITY_REQUIRED
| 5,341 | 11,297 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed by a neurologist; AND</p> <p>Patient must not have had the disease for more than 5 years; AND</p> <p>Patient must have at least 60 percent of predicted forced vital capacity within the 2 months before commencing therapy with this drug; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p> <p align="justify">The date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) must be supplied with the initial authority application.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Amyotrophic lateral sclerosis</p><br/><p>Initial treatment</p><br/><p>The condition must be diagnosed by a neurologist; AND</p> <p>Patient must not have had the disease for more than 5 years; AND</p> <p>Patient must have at least 60 percent of predicted forced vital capacity within the 2 months before commencing therapy with this drug; AND</p> <p>Patient must be ambulatory; or</p> <p>Patient must not be ambulatory, and must be able to either use upper limbs or to swallow; AND</p> <p>Patient must not have undergone a tracheostomy; AND</p> <p>Patient must not have experienced respiratory failure.</p> <p align="justify">The date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) must be supplied with the initial authority application.</p> <p align="justify"><b>Continuing Therapy Only:</b></p><p align="justify">For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner. Further information can be found in the Explanatory Notes for Nurse Practitioners. </p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-02-01
| 3,671 |
11310_11310_R
|
One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control
|
AUTHORITY_REQUIRED
| 11,310 | 11,310 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist''s name documented in the patient''s medical records for auditing purposes; or</p> <p>Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist''s name documented in the patient''s medical records for auditing purposes; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align="justify">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or</p> <p>Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist''s name documented in the patient''s medical records for auditing purposes; or</p> <p>Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist''s name documented in the patient''s medical records for auditing purposes; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align="justify">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-03-01
| 3,671 |
11334_8842_R
|
First continuing treatment, Face, hand, foot
|
AUTHORITY_REQUIRED
| 8,842 | 11,334 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align="justify">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align="justify">The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-03-01
| 3,671 |
11335_9162_R
|
First continuing treatment, Whole body
|
AUTHORITY_REQUIRED
| 9,162 | 11,335 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>First continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-03-01
| 3,671 |
11337_9123_R
|
First continuing treatment
|
AUTHORITY_REQUIRED
| 9,123 | 11,337 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form(s); and</p><p align="justify">(2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.</p> <p align="justify">Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-03-01
| 3,671 |
11347_8987_R
|
Continuing treatment, Face, hand, foot
|
AUTHORITY_REQUIRED
| 8,987 | 11,347 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p>At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Face, hand, foot</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p>At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p><p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-03-01
| 3,671 |
11360_11360_R
| null |
STREAMLINED
| 11,360 | 11,360 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Asthma</p><br/><p>Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; AND</p> <p>Patient must be aged 12 years or over.</p> <p align="justify">This product is not indicated for the initiation of treatment in asthma</p> <p align="justify">This product is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).</p> <p align="justify">The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)</p> <p align="justify">A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.</p> <p align="justify">Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before "stepping up" a patient's medication regimen.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-03-01
| 3,671 |
11368_8891_R
|
Continuing treatment, Whole body
|
AUTHORITY_REQUIRED
| 8,891 | 11,368 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p>At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Continuing treatment, Whole body</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p>At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.</p><p align="justify">The most recent PASI assessment must be no more than 1 month old at the time of application.</p><p align="justify">Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.</p> <p align="justify">It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-03-01
| 3,671 |
11370_11370_R
|
One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control
|
AUTHORITY_REQUIRED
| 11,370 | 11,370 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align="justify">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex gastro-oesophageal reflux disease (GORD)</p><br/><p>One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control</p><br/><p>Must be treated by a gastroenterologist; or</p> <p>Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND</p> <p>The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND</p> <p>Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; or</p> <p>Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; or</p> <p>Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; or</p> <p>Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.</p> <p align="justify">Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-03-01
| 3,671 |
11374_11374_R
|
Continuing or resuming treatment of the whole body
|
AUTHORITY_REQUIRED
| 11,374 | 11,374 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the whole body</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align="justify">For the purposes of this restriction, an adequate response to treatment is defined as:</p><p align="justify">(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and</p><p align="justify">(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align="justify">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.</p><p align="justify">State each of the current EASI and DLQI scores for this authority application.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the whole body</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align="justify">For the purposes of this restriction, an adequate response to treatment is defined as:</p><p align="justify">(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and</p><p align="justify">(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align="justify">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.</p><p align="justify">State each of the current EASI and DLQI scores for this authority application.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-03-01
| 3,671 |
11377_11377_R
|
Continuing or resuming treatment of the face and/or hands
|
AUTHORITY_REQUIRED
| 11,377 | 11,377 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the face and/or hands</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align="justify">For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:</p><p align="justify">(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or</p><p align="justify">(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and</p><p align="justify">(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align="justify">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.</p><p align="justify">Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic severe atopic dermatitis</p><br/><p>Continuing or resuming treatment of the face and/or hands</p><br/><p>Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND</p> <p>Patient must have achieved an adequate response within the first 16 weeks of treatment; or</p> <p>Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or</p> <p>Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND</p> <p>The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND</p> <p>Must be treated by a dermatologist; or</p> <p>Must be treated by a clinical immunologist.</p> <p align="justify">For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:</p><p align="justify">(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or</p><p align="justify">(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and</p><p align="justify">(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline</p><p align="justify">Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.</p><p align="justify">Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-03-01
| 3,671 |
11429_N
| null | null | null | null | null |
<p/><p align="justify">A LAMA includes tiotropium, glycopyrronium, aclidinium or umeclidinium.</p><p/>
|
Y
|
N
|
N
| null | null |
N
|
2014-11-01
| 3,671 |
11446_11445_R
| null |
STREAMLINED
| 11,445 | 11,446 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11449_11477_R
|
Continuing treatment as second-line drug therapy
|
STREAMLINED
| 11,477 | 11,449 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment as second-line drug therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p> <p align="justify">Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic non-small cell lung cancer</p><br/><p>Continuing treatment as second-line drug therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND</p> <p>Patient must have stable or responding disease.</p> <p align="justify">Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11451_11391_R
|
Continuing combination treatment (with nivolumab) of first-line drug therapy
|
STREAMLINED
| 11,391 | 11,451 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing combination treatment (with nivolumab) of first-line drug therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND</p> <p>The treatment must be in combination with nivolumab.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing combination treatment (with nivolumab) of first-line drug therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND</p> <p>The treatment must be in combination with nivolumab.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11461_11385_R
| null |
STREAMLINED
| 11,385 | 11,461 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Parkinson disease</p><br/><p>Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND</p> <p>The treatment must be commenced in a specialist unit in a hospital setting.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11467_11478_R
|
Initial combination treatment (with nivolumab) as first-line drug therapy
|
STREAMLINED
| 11,478 | 11,467 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial combination treatment (with nivolumab) as first-line drug therapy</p><br/><p>The condition must be squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must not have previously been treated for this condition in the metastatic setting; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND</p> <p>The treatment must be in combination with nivolumab.</p> <p align="justify">The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Initial combination treatment (with nivolumab) as first-line drug therapy</p><br/><p>The condition must be squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must not have previously been treated for this condition in the metastatic setting; AND</p> <p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND</p> <p>The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND</p> <p>The treatment must be in combination with nivolumab.</p> <p align="justify">The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.</p> <p align="justify">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11468_11468_R
|
Continuing combination treatment (with ipilimumab) of first-line drug therapy
|
STREAMLINED
| 11,468 | 11,468 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing combination treatment (with ipilimumab) of first-line drug therapy</p><br/><p>The condition must be squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND</p> <p>The treatment must be in combination with ipilimumab.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV (metastatic) non-small cell lung cancer (NSCLC)</p><br/><p>Continuing combination treatment (with ipilimumab) of first-line drug therapy</p><br/><p>The condition must be squamous type non-small cell lung cancer (NSCLC); AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND</p> <p>The treatment must be in combination with ipilimumab.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11468_N
| null | null | null | null | null |
<p align="justify">Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. </p>
|
Y
|
N
|
N
| null | null |
N
|
2014-11-01
| 3,671 |
11473_11473_R
| null |
STREAMLINED
| 11,473 | 11,473 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must not be premenopausal.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Locally advanced or metastatic breast cancer</p><br/><p>The condition must be hormone receptor positive; AND</p> <p>The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND</p> <p>The condition must be inoperable; AND</p> <p>Patient must not be premenopausal.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11482_11482_R
| null |
RESTRICTED
| 11,482 | 11,482 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine dependent epilepsy</p><br/><p>Patient must be managed on a low lysine diet for pyridoxine dependent epilepsy; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Pyridoxine dependent epilepsy</p><br/><p>Patient must be managed on a low lysine diet for pyridoxine dependent epilepsy; AND</p> <p>The condition must be treated by or in consultation with a metabolic physician.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11494_10431_R
|
Continuing treatment
|
AUTHORITY_REQUIRED
| 10,431 | 11,494 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align="justify">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align="justify">(a) a CRP measurement no greater than 10 mg per L; or</p><p align="justify">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align="justify">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align="justify">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Non-radiographic axial spondyloarthritis</p><br/><p>Continuing treatment</p><br/><p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.</p> <p align="justify">An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following:</p><p align="justify">(a) a CRP measurement no greater than 10 mg per L; or</p><p align="justify">(b) a CRP measurement reduced by at least 20% from baseline.</p> <p align="justify">If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.</p> <p align="justify">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11519_N
| null | null | null | null | null |
<p align="justify">For patients with graft versus host disease, acute myeloid leukaemia or myelodysplastic syndrome, applications for an increased maximum quantity to allow for up to 1 month's treatment and repeats sufficient for up to 6 months' treatment may be authorised. </p>
|
Y
|
N
|
N
| null | null |
N
|
2014-12-01
| 3,671 |
11520_N
| null | null | null | null | null |
<p align="justify">For patients undergoing allogeneic haematopoietic stem cell transplant, applications for an increased maximum quantity to allow for up to 1 month's treatment and repeats sufficient for up to 2 months' treatment may be authorised.</p>
|
Y
|
N
|
N
| null | null |
N
|
2014-12-01
| 3,671 |
11522_11604_R
|
Subsequent continuing treatment
|
STREAMLINED
| 11,604 | 11,522 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align="justify">AND either of the following:</p><p align="justify">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align="justify">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align="justify">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align="justify">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe active juvenile idiopathic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; </p><p align="justify">AND either of the following:</p><p align="justify">(a) an active joint count of fewer than 10 active (swollen and tender) joints; or</p><p align="justify">(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or</p><p align="justify">(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). </p> <p/><p align="justify">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11527_11631_R
|
Subsequent continuing treatment
|
STREAMLINED
| 11,631 | 11,527 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11528_11529_R
|
Subsequent continuing treatment
|
STREAMLINED
| 11,529 | 11,528 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">A response to treatment is defined as:</p><p align="justify">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe hidradenitis suppurativa</p><br/><p>Subsequent continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated a response to treatment with this drug for this condition; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">A response to treatment is defined as:</p><p align="justify">Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11532_N
| null | null | null | null | null |
<p/><p align="justify">A patient may only qualify for PBS-subsidised treatment under this restriction once in a lifetime.</p><p/>
|
Y
|
N
|
N
| null | null |
N
|
2014-12-01
| 3,671 |
11535_11635_R
|
Subsequent continuing treatment, Whole body
|
STREAMLINED
| 11,635 | 11,535 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Whole body</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="left">A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11580_11523_R
|
Subsequent continuing treatment
|
STREAMLINED
| 11,523 | 11,580 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11582_11579_R
|
Subsequent continuing treatment
|
STREAMLINED
| 11,579 | 11,582 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be 6 years of age or older.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be 6 years of age or older.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11595_N
| null | null | null | null | null |
<p/><p align="justify">Application for an increased maximum quantity to allow for up to 1 month's treatment and repeats sufficient for up to 6 months' treatment may be authorised.</p><p/>
|
Y
|
N
|
N
| null | null |
N
|
2014-12-01
| 3,671 |
11630_11606_R
|
Subsequent continuing treatment, Face, hand, foot
|
STREAMLINED
| 11,606 | 11,630 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe chronic plaque psoriasis</p><br/><p>Subsequent continuing treatment, Face, hand, foot</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND</p> <p>The treatment must be as systemic monotherapy (other than methotrexate); AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Must be treated by a dermatologist.</p> <p align="justify">An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:</p><p align="justify">(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or</p><p align="justify">(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11637_11524_R
|
Subsequent continuing treatment
|
STREAMLINED
| 11,524 | 11,637 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">A maximum of 24 weeks treatment will be authorised under this restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Complex refractory Fistulising Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug for this condition.</p> <p align="justify">An adequate response is defined as:</p><p align="justify">(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or</p><p align="justify">(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">A maximum of 24 weeks treatment will be authorised under this restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-04-01
| 3,671 |
11643_11642_R
| null |
STREAMLINED
| 11,642 | 11,643 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND</p> <p>The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND</p> <p>The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-05-01
| 3,671 |
11658_11644_R
| null |
RESTRICTED
| 11,644 | 11,658 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; AND</p> <p>Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Ketogenic diet</p><br/><p>Patient must have intractable seizures requiring treatment with a ketogenic diet; or</p> <p>Patient must have a glucose transport protein defect; or</p> <p>Patient must have pyruvate dehydrogenase deficiency; AND</p> <p>Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of: (i) a metabolic physician, (ii) a neurologist.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11673_11673_R
| null |
STREAMLINED
| 11,673 | 11,673 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11681_11681_R
| null |
AUTHORITY_REQUIRED
| 11,681 | 11,681 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND</p> <p>The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe myoclonic epilepsy in infancy (Dravet syndrome)</p><br/><p>Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND</p> <p>The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND</p> <p>Must be treated by a neurologist if treatment is being initiated; or</p> <p>Must be treated by a neurologist if treatment is being continued or re-initiated; or</p> <p>Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; or</p> <p>Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-05-01
| 3,671 |
11682_11680_R
| null |
STREAMLINED
| 11,680 | 11,682 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta-blocker; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic heart failure</p><br/><p>Patient must be symptomatic with NYHA classes II, III or IV; AND</p> <p>Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND</p> <p>Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta-blocker; AND</p> <p>Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or</p> <p>Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND</p> <p>The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11683_11683_R
| null |
RESTRICTED
| 11,683 | 11,683 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11696_11696_R
| null |
AUTHORITY_REQUIRED
| 11,696 | 11,696 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must not be opioid naive; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must not be opioid naive; AND</p> <p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
Y
|
2021-06-01
| 3,671 |
11697_11697_R
| null |
STREAMLINED
| 11,697 | 11,697 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
Y
|
2021-06-01
| 3,671 |
11698_6986_R
|
Continuing
|
STREAMLINED
| 6,986 | 11,698 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Continuing</p><br/><p>Patient must have previously received PBS-subsidised therapy for HIV infection; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11702_11763_R
|
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
|
AUTHORITY_REQUIRED
| 11,763 | 11,702 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have evidence of intestinal inflammation; or</p> <p>Patient must be assessed clinically as being in a high faecal output state; or</p> <p>Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or</p> <p>Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or</p> <p>Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND</p> <p>Patient must have evidence of intestinal inflammation; or</p> <p>Patient must be assessed clinically as being in a high faecal output state; or</p> <p>Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11703_11759_R
|
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
|
AUTHORITY_REQUIRED
| 11,759 | 11,703 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">Two completed authority prescriptions should be submitted with every initial application for this biological medicine.</p><p align="justify"><b>Prescribing the 40 mg presentation:</b></p><p align="justify">One prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.</p><p align="justify"><b>Prescribing the 80 mg presentation:</b></p><p align="justify">One prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11705_11709_R
|
Balance of supply
|
AUTHORITY_REQUIRED
| 11,709 | 11,705 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or subsequent continuing treatment.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or subsequent continuing treatment.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11710_11711_R
|
Subsequent continuing treatment
|
AUTHORITY_REQUIRED
| 11,711 | 11,710 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11712_11761_R
|
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
|
AUTHORITY_REQUIRED
| 11,761 | 11,712 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11714_11717_R
|
Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
|
AUTHORITY_REQUIRED
| 11,717 | 11,714 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 40 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">The PCDAI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 40 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">The PCDAI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11745_11746_R
| null |
RESTRICTED
| 11,746 | 11,745 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>For use in patients receiving palliative care</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11753_11753_R
| null |
AUTHORITY_REQUIRED
| 11,753 | 11,753 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe disabling pain</p><br/><p>Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics; or</p> <p>Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance; AND</p> <p>Patient must be undergoing palliative care.</p> <h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2</h1><p align="justify">Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.</p><p align="justify">Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
Y
|
2021-06-01
| 3,671 |
11754_6985_R
|
Initial
|
STREAMLINED
| 6,985 | 11,754 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>HIV infection</p><br/><p>Initial</p><br/><p>Patient must be antiretroviral treatment naive; AND</p> <p>The treatment must be in combination with other antiretroviral agents.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11756_11815_R
|
Induction treatment
|
AUTHORITY_REQUIRED
| 11,815 | 11,756 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must not exceed 10 doses for induction treatment with this drug for this condition.</p> <p align="justify">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align="justify">i) the previously untreated induction treatment restriction; or</p><p align="justify">ii) the rituximab-refractory re-induction restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Induction treatment</p><br/><p>The condition must be CD20 positive; AND</p> <p>The condition must be previously untreated; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for induction treatment purposes only; AND</p> <p>The treatment must be in combination with chemotherapy; AND</p> <p>The treatment must not exceed 10 doses for induction treatment with this drug for this condition.</p> <p align="justify">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align="justify">i) the previously untreated induction treatment restriction; or</p><p align="justify">ii) the rituximab-refractory re-induction restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11757_11785_R
|
Maintenance therapy
|
AUTHORITY_REQUIRED
| 11,785 | 11,757 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must have been refractory to treatment with rituximab; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the rituximab refractory initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must have been refractory to treatment with rituximab; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS-subsidised re-induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11764_11713_R
|
Balance of supply for paediatric patient
|
AUTHORITY_REQUIRED
| 11,713 | 11,764 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply for paediatric patient</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or subsequent continuing treatment; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Balance of supply for paediatric patient</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; or</p> <p>The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or subsequent continuing treatment; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11766_11767_R
|
First continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
|
AUTHORITY_REQUIRED
| 11,767 | 11,766 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>First continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 40 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">The PCDAI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>First continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 40 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">The PCDAI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
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N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11786_11787_R
|
Maintenance therapy
|
AUTHORITY_REQUIRED
| 11,787 | 11,786 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage II bulky or Stage III/IV follicular lymphoma</p><br/><p>Maintenance therapy</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction; AND</p> <p>The condition must be CD20 positive; AND</p> <p>Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition; AND</p> <p>The treatment must be maintenance therapy; AND</p> <p>The treatment must be the sole PBS-subsidised therapy for this condition; AND</p> <p>The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11788_11704_R
|
First continuing treatment
|
AUTHORITY_REQUIRED
| 11,704 | 11,788 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or</p> <p>Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11800_11699_R
|
Maintenance therapy - Continuing treatment
|
AUTHORITY_REQUIRED
| 11,699 | 11,800 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Maintenance therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing or have undergone a stem cell transplant.</p> <p align="justify">A maximum of 9 cycles will be authorised under this restriction in a lifetime.</p> <p align="justify">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align="justify">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align="justify">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Acute Myeloid Leukaemia</p><br/><p>Maintenance therapy - Continuing treatment</p><br/><p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND</p> <p>Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must not be undergoing or have undergone a stem cell transplant.</p> <p align="justify">A maximum of 9 cycles will be authorised under this restriction in a lifetime.</p> <p align="justify">Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.</p><p align="justify">If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.</p><p align="justify">Progressive disease is defined as the presence of any of the following:</p><ul><li>Leukaemic cells in the CSF;</li><li>Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;</li><li>Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;</li><li>Extramedullary leukaemia.</li></ul> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11802_11759_R
|
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
|
AUTHORITY_REQUIRED
| 11,759 | 11,802 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11803_11762_R
|
Initial treatment - Initial 1 (new patient)
|
AUTHORITY_REQUIRED
| 11,762 | 11,803 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:</p><p align="justify">(a) patient must have evidence of intestinal inflammation;</p><p align="justify">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align="justify">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align="justify">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. </p> <p/><p align="justify">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. </p><p/> <p align="justify">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align="justify">Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must be aged 18 years or older; AND</p> <p>Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND</p> <p>Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or</p> <p>Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND</p> <p>Patient must not receive more than 16 weeks of treatment under this restriction; AND</p> <p>Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; or</p> <p>Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; or</p> <p>Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) two completed authority prescription forms; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:</p><p align="justify">(a) patient must have evidence of intestinal inflammation;</p><p align="justify">(b) patient must be assessed clinically as being in a high faecal output state;</p><p align="justify">(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.</p><p align="justify">Evidence of intestinal inflammation includes:</p><p align="justify">(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or</p><p align="justify">(ii) faeces: higher than normal lactoferrin or calprotectin level; or</p><p align="justify">(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.</p> <p align="justify">Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.</p> <p align="justify">All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.</p> <p align="justify">If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. </p> <p/><p align="justify">If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. </p><p/> <p align="justify">Details of the accepted toxicities including severity can be found on the Services Australia website.</p> <p align="justify">Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
|
N
|
N
|
N
|
FULL
|
ALL
|
N
|
2021-06-01
| 3,671 |
11804_11718_R
|
Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
|
STREAMLINED
| 11,718 | 11,804 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 40 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">The PCDAI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe Crohn disease</p><br/><p>Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI</p><br/><p>Patient must have a documented history of severe Crohn disease; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND</p> <p>Patient must have a total PCDAI score of 40 points or less; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 6 to 17 years inclusive; AND</p> <p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist.</p> <p align="justify">The measurement of response to the prior course of therapy must be documented in the patient's medical notes.</p> <p align="justify">The PCDAI assessment must be no more than 4 weeks old at the time of application.</p> <p align="justify">Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11809_11755_R
|
Re-induction treatment
|
AUTHORITY_REQUIRED
| 11,755 | 11,809 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Re-induction treatment</p><br/><p>Patient must not have previously received PBS-subsidised obinutuzumab; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must be refractory to treatment with rituximab for this condition; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for re-induction treatment purposes only; AND</p> <p>The treatment must be in combination with bendamustine; AND</p> <p>The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.</p> <p align="justify">The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.</p> <p align="justify">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align="justify">i) the previously untreated induction treatment restriction; or</p><p align="justify">ii) the rituximab-refractory re-induction restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Follicular lymphoma</p><br/><p>Re-induction treatment</p><br/><p>Patient must not have previously received PBS-subsidised obinutuzumab; AND</p> <p>The condition must be CD20 positive; AND</p> <p>The condition must be refractory to treatment with rituximab for this condition; AND</p> <p>The condition must be symptomatic; AND</p> <p>The treatment must be for re-induction treatment purposes only; AND</p> <p>The treatment must be in combination with bendamustine; AND</p> <p>The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.</p> <p align="justify">The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.</p> <p align="justify">A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under:</p><p align="justify">i) the previously untreated induction treatment restriction; or</p><p align="justify">ii) the rituximab-refractory re-induction restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11819_11784_R
| null |
STREAMLINED
| 11,784 | 11,819 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Chronic migraine</p><br/><p>Must be treated by a neurologist; AND</p> <p>Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for continuing PBS-subsidised treatment; AND</p> <p>Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with botulinum toxin; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align="justify">Contraindications to treatment include known sensitivity to botulinum toxin.</p> <p>Chronic migraine</p><br/><p>Must be treated by a neurologist; AND</p> <p>Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with botulinum toxin type A neurotoxin; AND</p> <p>Patient must have achieved and maintained a 50% or greater reduction from baseline in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for continuing PBS-subsidised treatment; AND</p> <p>Patient must be appropriately managed by his or her practitioner for medication overuse headache, prior to initiation of treatment with botulinum toxin; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate.</p> <p>The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-06-01
| 3,671 |
11829_11939_R
|
Continuing treatment beyond 3 months
|
STREAMLINED
| 11,939 | 11,829 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>Patient must require dose adjustment; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align="justify">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align="justify">Complete response (CR) is disappearance of all target lesions.</p><p align="justify">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align="justify">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align="justify">Stable disease (SD) is small changes that do not meet above criteria.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11830_11915_R
|
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
|
AUTHORITY_REQUIRED
| 11,915 | 11,830 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align="justify">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.</p> <p align="justify">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11831_11890_R
|
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
|
AUTHORITY_REQUIRED
| 11,890 | 11,831 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy.</p> <p align="justify">Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND</p> <p>Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy.</p> <p align="justify">Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response to treatment with this drug.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11832_11981_R
|
Initial treatment - Initial 1 (new patient)
|
AUTHORITY_REQUIRED
| 11,981 | 11,832 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11833_11834_R
|
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
|
AUTHORITY_REQUIRED
| 11,834 | 11,833 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">All measures of joint count, ESR and/or CRP must be no more than 4 weeks old at the time of application.</p> <p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align="justify">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">All measures of joint count, ESR and/or CRP must be no more than 4 weeks old at the time of application.</p> <p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align="justify">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.</p> <p align="justify">To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11835_11835_R
| null |
STREAMLINED
| 11,835 | 11,835 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Prevention of preterm birth</p><br/><p>Patient must have a singleton pregnancy; AND</p> <p>Patient must have at least one of: (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND</p> <p>The treatment must be administered no earlier than at 16 weeks gestation.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11837_11960_R
|
Existing pregnancy to birth
|
AUTHORITY_REQUIRED
| 11,960 | 11,837 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Existing pregnancy to birth</p><br/><p>Patient must be pregnant; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND</p> <p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must not be undergoing further treatment with this drug as a PBS benefit, post-partum in the absence of actively trying to conceive a subsequent child/a known subsequent pregnancy; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously).</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)</p><br/><p>Existing pregnancy to birth</p><br/><p>Patient must be pregnant; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%; AND</p> <p>Must be treated by a metabolic physician; or</p> <p>Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND</p> <p>Patient must not be undergoing further treatment with this drug as a PBS benefit, post-partum in the absence of actively trying to conceive a subsequent child/a known subsequent pregnancy; AND</p> <p>Patient must not be undergoing simultaneous treatment with this drug under another non-maternal PBS-listing (apply under either listing type, but not both simultaneously).</p> <p align="justify">Request an appropriate maximum quantity (with the number of packs being a whole number) to provide approximately 30 days treatment duration per dispensing, based on dosing no greater than 20 mg/kg per day.</p> <p align="justify">Request an appropriate number of repeats (whole number) relative to the expected birth date such that treatment is not continued post-partum by a whole prescription quantity. If the expected birth date is within the next 30 days at the time of the authority application, do not request repeats.</p> <p align="justify">This PBS listing intends to subsidise treatment only whilst the patient is pregnant. Treatment is to be discontinued upon birth under this listing. Whilst a patient may benefit from continued treatment post-partum, continued treatment with this drug post-partum is not PBS subsidised in the absence of actively trying to conceive again/a known subsequent pregnancy.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11849_11966_R
|
Continuing treatment - balance of supply
|
AUTHORITY_REQUIRED
| 11,966 | 11,849 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11850_11853_R
|
Subsequent continuing treatment
|
AUTHORITY_REQUIRED
| 11,853 | 11,850 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11856_9715_R
|
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
|
AUTHORITY_REQUIRED
| 9,715 | 11,856 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11859_9064_R
|
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
|
AUTHORITY_REQUIRED
| 9,064 | 11,859 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11862_11867_R
|
First continuing treatment
|
AUTHORITY_REQUIRED
| 11,867 | 11,862 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11863_11865_R
|
Subsequent continuing treatment
|
AUTHORITY_REQUIRED
| 11,865 | 11,863 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Subsequent continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug within this treatment cycle, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11876_11974_R
|
Initial treatment
|
STREAMLINED
| 11,974 | 11,876 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align="justify">Patients who have developed intolerance to sunitinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised pazopanib.</p> <p>Patients who have progressive disease with pazopanib are no longer eligible for PBS-subsidised pazopanib.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11877_11937_R
|
Continuing treatment beyond 3 months
|
STREAMLINED
| 11,937 | 11,877 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align="justify">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align="justify">Complete response (CR) is disappearance of all target lesions.</p><p align="justify">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align="justify">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align="justify">Stable disease (SD) is small changes that do not meet above criteria.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11881_11975_R
|
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
|
AUTHORITY_REQUIRED
| 11,975 | 11,881 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="left">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>Patient must have a Mayo clinic score greater than or equal to 6; or</p> <p>Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(1) a completed authority prescription form; and</p><p align="justify">(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:</p><p align="justify">(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and</p><p align="justify">(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.</p> <p align="left">The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.</p> <p align="justify">An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A maximum of 16 weeks of treatment with this drug will be approved under this criterion.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11885_11886_R
|
Continuing treatment - balance of supply
|
AUTHORITY_REQUIRED
| 11,886 | 11,885 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11887_11919_R
|
Initial treatment - Initial 1 (new patient)
|
AUTHORITY_REQUIRED
| 11,919 | 11,887 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 1 (new patient)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND</p> <p>Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or</p> <p>Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p>Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.</p> <p>Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.</p> <p align="justify">The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: </p><p align="justify">an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and</p><p align="justify">either</p><p align="justify">(a) an active joint count of at least 20 active (swollen and tender) joints; or</p><p align="justify">(b) at least 4 active joints from the following list of major joints:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p><p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11888_11979_R
|
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
|
AUTHORITY_REQUIRED
| 11,979 | 11,888 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align="justify">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND</p> <p>Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND</p> <p>The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or</p> <p>The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND</p> <p>The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND</p> <p>Patient must not receive more than 20 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.</p> <p align="justify">If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.</p> <p/><p align="justify">Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. </p><p/> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11889_9172_R
|
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
|
AUTHORITY_REQUIRED
| 9,172 | 11,889 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11907_8555_R
|
Induction treatment
|
STREAMLINED
| 8,555 | 11,907 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Induction treatment</p><br/><p>The condition must not have previously been treated; AND</p> <p>The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.</p> <p align="justify">Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.</p> <p align="justify">The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p align="justify">Combination treatment with ipilimumab and nivolumab is associated with an increased incidence and severity of immune-related adverse reactions compared with monotherapy with these agents. Monitoring at least prior to each dose is recommended.</p> <p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Induction treatment</p><br/><p>The condition must not have previously been treated; AND</p> <p>The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.</p> <p align="justify">Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.</p> <p align="justify">The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.</p> <p align="justify">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p> <p align="justify"><i>A</i> prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk score can be calculated here: https://www.mdcalc.com/imdc-international-metastatic-rcc-database-consortium-risk-model-metastatic-renal-cell-carcinoma.</p><p align="justify">One point is assigned for each of:</p><p align="justify">(i) a time of diagnosis to systemic therapy of less than 1 year</p><p align="justify">(ii) a Karnofsky Performance Status of less than 80%</p><p align="justify">(iii) a haemoglobin less than the lower limit of normal</p><p align="justify">(iv) a corrected calcium level greater than the upper limit of normal</p><p align="justify">(v) a neutrophil count greater than the upper limit of normal</p><p align="justify">(vi) a platelet count greater than the upper limit of normal</p><p align="justify">Stated normal reference ranges may vary depending on the laboratory providing the measurement. 'Normal' here refers to the individual laboratory's stated normal reference range.</p><p align="justify">Favourable IMDC risk is a score of 0.</p><p align="justify">Intermediate IMDC risk is a score of 1 to 2.</p><p align="justify">Poor IMDC risk is a score of 3 to 6.</p><p align="justify">Document any IMDC risk score assessment in the patient's medical records.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11908_11930_R
| null |
STREAMLINED
| 11,930 | 11,908 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable malignant mesothelioma</p><br/><p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with PBS-subsidised nivolumab for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Unresectable malignant mesothelioma</p><br/><p>Patient must have a WHO performance status of 0 or 1; AND</p> <p>The treatment must be in combination with PBS-subsidised nivolumab for this condition; AND</p> <p>Patient must not have developed disease progression while being treated with this drug for this condition; AND</p> <p>The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.</p> <p align="justify">In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11914_11878_R
|
Initial treatment
|
STREAMLINED
| 11,878 | 11,914 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Initial treatment</p><br/><p>The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND</p> <p>Patient must have a WHO performance status of 2 or less; AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align="justify">Patients who have developed intolerance to pazopanib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.</p> <p align="justify">Patients who have progressive disease with sunitinib are no longer eligible for PBS-subsidised sunitinib.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11920_9172_R
|
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
|
AUTHORITY_REQUIRED
| 9,172 | 11,920 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11921_11959_R
|
Continuing treatment
|
AUTHORITY_REQUIRED
| 11,959 | 11,921 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
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<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment</p><br/><p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND</p> <p>Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND</p> <p>Patient must have demonstrated an adequate response to treatment with this drug; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">An adequate response to treatment is defined as:</p><p align="justify">an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and</p><p align="justify">either of the following:</p><p align="justify">(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or</p><p align="justify">(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:</p><p align="justify">(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or</p><p align="justify">(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).</p> <p align="justify">The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.</p> <p align="justify">The authority application must be made in writing and must include:</p><p align="justify">(a) a completed authority prescription form(s); and</p><p align="justify">(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p><p align="justify">Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au</p><p align="justify">Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos</p><p align="justify">Or mailed to:</p><p align="justify">Services Australia</p><p align="justify">Complex Drugs</p><p align="justify">Reply Paid 9826</p><p align="justify">HOBART TAS 7001</p>
|
N
|
N
|
Y
|
FULL
|
ALL
|
N
|
2021-07-01
| 3,671 |
11928_11903_R
|
First continuing treatment
|
AUTHORITY_REQUIRED
| 11,903 | 11,928 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>First continuing treatment</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or</p> <p>Must be treated by a paediatrician; or</p> <p>Must be treated by a specialist paediatric gastroenterologist; AND</p> <p>Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND</p> <p>Patient must be 6 years of age or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align="justify">Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.</p>
|
N
|
N
|
N
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11929_11906_R
|
Continuing treatment - balance of supply
|
AUTHORITY_REQUIRED
| 11,906 | 11,929 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Severe psoriatic arthritis</p><br/><p>Continuing treatment - balance of supply</p><br/><p>Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or</p> <p>Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND</p> <p>The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND</p> <p>Must be treated by a rheumatologist; or</p> <p>Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11935_11826_R
|
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
|
AUTHORITY_REQUIRED
| 11,826 | 11,935 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab intravenous form continuing treatment restriction; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed within 4 weeks prior to completing their current course of treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Moderate to severe ulcerative colitis</p><br/><p>Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form</p><br/><p>Must be treated by a gastroenterologist (code 87); or</p> <p>Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or</p> <p>Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND</p> <p>Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; or</p> <p>Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab intravenous form continuing treatment restriction; AND</p> <p>Patient must not receive more than 24 weeks of treatment under this restriction; AND</p> <p>Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or</p> <p>Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND</p> <p>Patient must be aged 18 years or older.</p> <p align="justify">Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.</p> <p align="justify">Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.</p> <p align="justify">At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.</p> <p align="justify">An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.</p> <p align="justify">The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed within 4 weeks prior to completing their current course of treatment.</p> <p align="justify">Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.</p> <p align="justify">If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.</p> <p align="justify">A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.</p> <p align="justify">Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).</p>
|
N
|
N
|
Y
|
IMMEDIATE
|
ALL
|
N
|
2021-07-01
| 3,671 |
11938_11875_R
|
Continuing treatment beyond 3 months
|
STREAMLINED
| 11,875 | 11,938 |
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p>
|
<h1>Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1</h1><p>Stage IV clear cell variant renal cell carcinoma (RCC)</p><br/><p>Continuing treatment beyond 3 months</p><br/><p>Patient must have received an initial authority prescription for this drug for this condition; AND</p> <p>Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND</p> <p>The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.</p> <p align="justify">A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. </p> <p align="justify">PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.</p> <p align="justify">Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:</p><p align="justify">Complete response (CR) is disappearance of all target lesions.</p><p align="justify">Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.</p><p align="justify">Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.</p><p align="justify">Stable disease (SD) is small changes that do not meet above criteria.</p>
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N
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N
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N
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IMMEDIATE
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ALL
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N
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2021-07-01
| 3,671 |
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