Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p418
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 418/476)
Character Range: 3558777–3564677

2 months of therapy; 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.
                                                                                                                                            The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
                                                                                                                                            (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 of major joints:
                                                                                                                                            (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 assessment of response to prior treatment must be documented in the patient's medical records.
                                                                                                                                            The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
                                                                                                                                            (a) an active joint count of at least 2 active joints; and
                                                                                                                                            (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
                                                                                                                                            (c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
                                                                                                                                            The assessment of response to prior treatment must be documented in the patient's medical records.
                                                                                                                                            The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                                                            The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
                                                                                                                                            Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
                                                                                                                                            Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, 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