Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p404
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 404/476)
Character Range: 3484264–3490277

an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
                                                                                                                                            Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                       C12436                                                               Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            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 paediatric rheumatologist; OR
                                                                                                                                            Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                                                                                            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 under 18 years of age.
                                                                                                                                            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.
                                                                                                                                            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