Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p196
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 196/476)
Character Range: 2026305–2030967

must not receive more than 22 weeks of treatment under this restriction; AND
                                                                                                                                            The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder 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).
                                                                                                                                            All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
                                                                                                                                            If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
                                                                                                                                            Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
                                                                                                                                            Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) the active joint count, ESR and/or CRP result and date of result;
                                                                                                                                            (b) the most recent biological agent and the date of the last continuing prescription.
                                                                                                                                            (c) If applicable, the new baseline scores.
                                                                                                                                            To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                                            Where a response assessment is not conducted within the required