Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p167
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 167/476)
Character Range: 1871604–1878059

TGA‑approved Product Information, details must be provided at the time of application.
                                                                                                                                            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.
                                                                                                                                            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.
                                                                                                                                            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.
                                                                                                                                            Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                       C13518                                                               Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 1 (new patient)
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                                            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 at a dose of up to 20 mg daily for a minimum period of 3 months; AND
                                                                                                                                            Patient must not receive more than 22 weeks of treatment under this restriction.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            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.
                                                                                                                                            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.
                                                                                                                                            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:
                                                                                                                                            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
                                                                                                                                            either
                                                                                                                                            (a) an active joint count of