Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p342
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 342/476)
Character Range: 3047327–3053773

up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions.
                                                                                                                                            Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats.
                                                                                                                                            The assessment of the patient's response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated.
                                                                                                                                            Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
Risdiplam                                                              C14368                                                               Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                                            Initial PBS‑subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood
                                                                                                                                            Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND
                                                                                                                                            Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS‑subsidised).
                                                                                                                                            Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
                                                                                                                                            Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
                                                                                                                                            Patient must be undergoing initial PBS‑subsidised treatment with this drug for untreated disease; OR
                                                                                                                                            Patient must be undergoing initial PBS‑subsidised treatment, but the patient has initiated treatment via non‑PBS supply (e.g. clinical trial, sponsor compassionate access); AND
                                                                                                                                            Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
                                                                                                                                            The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
                                                                                                                                            The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
                                                                                                                                            Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
                                                                                                                                            Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
                                                                                                                                            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