Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p13
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 13/476)
Character Range: 763744–769430

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 injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. 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 details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                                                            The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
                                                                                                                                            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 within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. 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 approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
                                                                                                                                            If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle.
                                                                       C14063                                                               Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more 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