Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p410
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 410/476)
Character Range: 3515817–3521643

(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.
                                                                                                                                            Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment 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 approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
                                                                                                                                            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 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.
                                                                       C14083                                                               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 must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have had a break in treatment of 12 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
                                                                                                                                            The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
                                                                                                                                            Patient must not