Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p157
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 157/191)
Character Range: 11108846–11116210

biological medicine treatment 3 times in their last treatment cycle; AND
                                                                                                                                                                                                                               The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                                                                                                                                                               The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                                                                                                                               The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
                                                                                                                                                                                                                               Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               Active joints are defined as
                                                                                                                                                                                                                               (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                                                                                                               (ii) shoulder, cervical spine 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).
                                                                                                                                                                                                                               All measures of joint count must be no more than 4 weeks old at the time of this application.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               (1) completed authority prescription form(s); and
                                                                                                                                                                                                                               (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
                                                                                                                                                                                                                               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.
C9477               P9477          CN9477           Tocilizumab                                                                                                                                                                Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of