Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p274
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 274/476)
Character Range: 2565851–2572524

medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); 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; AND
                                                                                                                                            The treatment must be given concomitantly with best supportive care for this condition; AND
                                                                                                                                            The treatment must not be in combination with PBS‑subsidised treatment with risdiplam for this condition.
                                                                                                                                            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
                                                                                                                                            Patient must be undergoing treatment under this Treatment phase listing once only ‑ for continuing treatment beyond this authority application, refer to the drug's relevant 'Continuing treatment' listing for the patient's SMA type.
                                                                                                                                            Patient must have a prior authority approval for any drug PBS‑listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy; OR
                                                                                                                                            Patient must have a prior authority approval for any drug PBS‑listed for pre‑symptomatic SMA, with at least one approval having been for gene therapy.
                                                                                                                                            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 treated with nusinersen.
                                                                                                                                            Definition:
                                                                                                                                            Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.
                                                                                                                                            0. Absence of developmental states (1 to 9) listed below:
                                                                                                                                            1. Rolls from side to side on back;
                                                                                                                                            2. Child holds head erect for at least 3 seconds unsupported;
                                                                                                                                            3. Sitting, but with assistance;
                                                                                                                                            4. Sitting without assistance:
                                                                                                                                            (a) Child sits up straight with the head erect for at least 10 seconds;
                                                                                                                                            (b) Child does not use arms or hands to balance body or support position.
                                                                                                                                            5. Hands and knees crawling:
                                                                                                                                            (a) Child alternately moves forward or backwards on hands and knees;
                                                                                                                                            (b) The stomach does not touch the supporting surface;
                                                                                                                                            (c) There are continuous and consecutive movements at least 3