Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p403
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 403/476)
Character Range: 3479452–3484511

to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
                                                                                                                                            The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
                                                                                                                                            The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
                                                                                                                                            If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
                                                                                                                                            The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
                                                                                                                                            an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
                                                                                                                                            (a) an active joint count of at least 20 active (swollen and tender) joints; or
                                                                                                                                            (b) at least 4 active joints from the following list:
                                                                                                                                            (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 joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
                                                                                                                                            If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) completed authority prescription form(s); and
                                                                                                                                            (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
                                                                                                                                            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 prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later