Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p419
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 419/476)
Character Range: 3564105–3570544

or serious sepsis.
                                                                                                                                            If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
                                                                                                                                            If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
                                                                                                                                            The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and
                                                                                                                                            (b) the details of prior treatment including dose and duration of treatment.
                                                                                                                                            The following reports must be documented in the patient's medical records where appropriate:
                                                                                                                                            (a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
                                                                                                                                            At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
                                                                                                                                            The assessment of the patient's response to the initial course of treatment 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 this course of treatment in this treatment cycle.
                                                                       C14162                                                               Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 1 (new patient)
                                                                                                                                            Must be treated by a paediatric rheumatologist; OR
                                                                                                                                            Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                                                                                            Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
                                                                                                                                            Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
                                                                                                                                            Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                                            Patient must be under 18 years of age.
                                                                                                                                            Severe intolerance