Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p401
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 401/476)
Character Range: 3469283–3476340

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.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                                                                                            If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle.
                                                                       C10570                                                               Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                            Balance of supply for Initial treatment ‑ Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment.
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                       C12163                                                               Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 1 (new patient)
                                                                                                                                            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 a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
                                                                                                                                            Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at