Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p247
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 247/312)
Character Range: 17024956–17030211

adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS-subsidised treatment with this drug for this condition; 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 prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug for this condition if the patient has received non-PBS-subsidised treatment for at least 12 weeks; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                           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 at least 20 active (swollen and tender) joints; or
                                                                                                                           (b) at least 4 active joints from the following list of major joints:
                                                                                                                           (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).
                                                                                                                           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. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
                                                                                                                           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