Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p408
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 408/476)
Character Range: 3504913–3510560

Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
                                                                                                                                            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 been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
                                                                                                                                            Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
                                                                                                                                            Patient must not receive more than 16 weeks of treatment under this restriction.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            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 has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
                                                                                                                                            If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
                                                                                                                                            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.
                                                                                                                                            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).
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate