Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p422
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 422/476)
Character Range: 3580834–3587590

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.
                                                                       C14179                                                               Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14179
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                                                                                            An adequate response to treatment is defined as:
                                                                                                                                            (a) in a patient with polyarticular course disease:
                                                                                                                                            (i) 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
                                                                                                                                            (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
                                                                                                                                            ‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                            ‑ 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).
                                                                                                                                            (b) in a patient with refractory systemic symptoms:
                                                                                                                                            (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
                                                                                                                                            (ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
                                                                                                                                            (iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
                                                                                                                                            The assessment