Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p5
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 5/476)
Character Range: 720604–727355

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 authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
                                                                                                                                            Up to a maximum of 4 repeats will be authorised.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form; and
                                                                                                                                            (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
                                                                                                                                            A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
                                                                       C14524                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; 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
                                                                                                                                            The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
                                                                                                                                            The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                                            The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
                                                                                                                                            Patient must not receive more than 16 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,