Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p51
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 51/162)
Character Range: 14925237–14930256

Initial treatment - Initial 1 (new patient weighing less than 30 kg)
                                                                                                         Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or
                                                                                                         Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or
                                                                                                         Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 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