Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p127
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 127/191)
Character Range: 10846189–10853140

application must be made in writing and must include
                                                                                                                                                                                                                               (1) a completed authority prescription form(s); and
                                                                                                                                                                                                                               (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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.
C9155               P9155          CN9155           Golimumab                                                                                                                                                                  Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient)
                                                    Secukinumab                                                                                                                                                                Must be treated by a rheumatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                                                                                                                                                               Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; 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