Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p281
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 281/476)
Character Range: 2613395–2619599

SMA (1 or 2 copies of the SMN2 gene) listing
                                                                                                                                            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; or initiated 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; AND
                                                                                                                                            Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                                            Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND
                                                                                                                                            The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND
                                                                                                                                            The treatment must be given concomitantly with best supportive care for this condition; AND
                                                                                                                                            The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.
                                                                                                                                            Patient must have been 18 years of age or younger at the time of initial treatment with this drug.
                                                                                                                                            Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
                                                                                                                                            In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.
                                                                       C15112                                                               Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listing
                                                                                                                                            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; or initiated 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; AND
                                                                                                                                            Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                                            Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND
                                                                                                                                            The treatment must