Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p413
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 413/476)
Character Range: 3531330–3537798

authority approval is required for each strength requested.
                                                                                                                                            An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to 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 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.
                                                                       C14091                                                               Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with this drug for this condition in the previous 12 months; AND
                                                                                                                                            Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug more than once during the current treatment cycle; AND
                                                                                                                                            Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                                            Patient must be under 18 years of age.
                                                                                                                                            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