Health Boards
Here is a copy of the prescribing restrictions from the pbs for psa. How does this fit with you? I will be contacting the PBS for clarification:
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Severe active psoriatic arthritis
Treatment Phase: Initial 3 - grandfather treatment
Clinical criteria:
Patient must have a documented history of severe active psoriatic arthritis,
AND
Patient must have received non-PBS treatment with this drug for this condition prior to 1 October 2016,
AND
Patient must be receiving treatment with this drug for this condition at the time of application,
AND
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
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
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
Patient must have demonstrated an adequate response to treatment with this drug,
AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Population criteria:
Patient must be aged 18 years or older.
Treatment criteria:
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
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
either of the following:
(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
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to response, or to have failed to sustain a response to treatment with this drug.
Patients may qualify for PBS-subsidised treatment under this restriction once only. Further applications for treatment with this drug will be assessed under the continuing treatment restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement; and
(4) the date of commencement of this drug; and
(5) results of the baseline patient assessment prior to commencing treatment with this drug.
Note
Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at NO LINKS ALLOWED
Applications for authority to prescribe should be forwarded to:
Department of Human Services
Complex Drugs
Reply Paid 9826
HOBART TAS 7001 >
<
Severe active psoriatic arthritis
Treatment Phase: Initial 3 - grandfather treatment
Clinical criteria:
Patient must have a documented history of severe active psoriatic arthritis,
AND
Patient must have received non-PBS treatment with this drug for this condition prior to 1 October 2016,
AND
Patient must be receiving treatment with this drug for this condition at the time of application,
AND
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
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
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
Patient must have demonstrated an adequate response to treatment with this drug,
AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Population criteria:
Patient must be aged 18 years or older.
Treatment criteria:
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
An adequate response to treatment is defined as:
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
either of the following:
(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
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to response, or to have failed to sustain a response to treatment with this drug.
Patients may qualify for PBS-subsidised treatment under this restriction once only. Further applications for treatment with this drug will be assessed under the continuing treatment restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement; and
(4) the date of commencement of this drug; and
(5) results of the baseline patient assessment prior to commencing treatment with this drug.
Note
Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at NO LINKS ALLOWED
Applications for authority to prescribe should be forwarded to:
Department of Human Services
Complex Drugs
Reply Paid 9826
HOBART TAS 7001 >