Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p135
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 135/191)
Character Range: 10900762–10909820

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.
C9180               P9180          CN9180           Tocilizumab                                                                                                                                                                Active giant cell arteritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must not exceed 52 weeks in total including initial and continuing applications.
C9183               P9183          CN9183           Certolizumab pegol                                                                                                                                                         Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient)
                                                                                                                                                                                                                               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 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
                                                                                                                                                                                                                               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