Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p207
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 207/476)
Character Range: 2083580–2089141

clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
                                                                                                                                            Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
                                                                                                                                            Patient 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.
                                                                                                                                            Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
                                                                                                                                            Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
                                                                                                                                            An adequate response to treatment is defined as:
                                                                                                                                            an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
                                                                                                                                            AND either of the following:
                                                                                                                                            (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                                            (b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
                                                                                                                                            (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).
                                                                                                                                            The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                                            An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
                                                                                                                                            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