Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p302
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 302/476)
Character Range: 2756368–2763279

Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)
                                                                                                                                            The treatment must be given concomitantly with best supportive care for this condition; AND
                                                                                                                                            The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.
                                                                                                                                            Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND
                                                                                                                                            Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
                                                                                                                                            Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND
                                                                                                                                            Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND
                                                                                                                                            Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.
                                                                                                                                            Patient must be no older than 9 months of age; AND
                                                                                                                                            Patient must have symptomatic Type 1 SMA; OR
                                                                                                                                            Patient must have pre-symptomatic SMA with 1-2 copies of SMN2 gene.
                                                                                                                                            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).
                                                                                                                                            Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.
                                                                                                                                            Confirm that a previous PBS authority application has been approved for one of the following:
                                                                                                                                            (i) Symptomatic Type 1 SMA; or
                                                                                                                                            (ii) Pre-symptomatic SMA with 1-2 copies of SMN2 gene.
                                                                                                                                            State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.
                                                                                                                                            Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.
                                                                       C15989                                                               Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                                            Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)
                                                                                                                                            The treatment must