Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p416
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 416/476)
Character Range: 3548086–3554144

up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
                                                                                                                                            If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                       C14145                                                               Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
                                                                                                                                            Must be treated by a paediatric rheumatologist; OR
                                                                                                                                            Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                            Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                                                                            Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                                            An adequate response to treatment is defined as:
                                                                                                                                            (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                                            (b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
                                                                                                                                            (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).
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                                            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 approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to