Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p110
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 110/381)
Character Range: 12231748–12239782

or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy.
                                                                                                                                                                    Where an assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond, or to have failed to sustain a response 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.
C11918              P11918         CN11918          Guselkumab                                                                                                      Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment - balance of supply
                                                    Ixekizumab                                                                                                      Must be treated by a rheumatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
C11919              P11919         CN11919          Guselkumab                                                                                                      Severe psoriatic 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 psoriatic arthritis; AND
                                                                                                                                                                    Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
                                                                                                                                                                    Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or
                                                                                                                                                                    Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
                                                                                                                                                                    Patient must not receive more than 20 weeks of treatment under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                                                                                    Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent