Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p168
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 168/381)
Character Range: 12613452–12620329

times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C12404              P12404         CN12404          Tocilizumab                                                                                                     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; AND
                                                                                                                                                                    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;
                                                                                                                                                                    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).
                                                                                                                                                                    Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
                                                                                                                                                                    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.
                                                                                                                                                                    An adequate response to treatment is defined as
                                                                                                                                                                    (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, cervical spine 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).
                                                                                                                                                                    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