Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p396
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 396/476)
Character Range: 3441295–3448070

the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
                                                                       C9407                                                                Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have a break in treatment of 24 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; OR
                                                                                                                                            Patient must not have received PBS‑subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS‑subsidised 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.
                                                                                                                                            At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            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