Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p350
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 350/476)
Character Range: 3102562–3110174

mg/kg
                                                                                                                                            (ii) 2 months to less than 2 years of age: 0.20 mg/kg
                                                                                                                                            (iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
                                                                                                                                            (iv) 2 years of age and older weighing 20 kg or more: 5 mg
                                                                                                                                            In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
                                                                                                                                            1 unit where (i) applies;
                                                                                                                                            2 units where (ii) applies;
                                                                                                                                            3 units where (iii) applies;
                                                                                                                                            3 units where (iv) applies.
                                                                       C15095                                                               Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)
                                                                                                                                            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 nusinersen for this condition; AND
                                                                                                                                            The treatment must not be in combination with PBS-subsidised treatment with nusinersen 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; AND
                                                                                                                                            The treatment must be given concomitantly with best supportive care for this condition.
                                                                                                                                            Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; 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 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 nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.
                                                                                                                                            The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.
                                                                                                                                            The approved Product Information recommended dosing is as follows:
                                                                                                                                            (i) 16 days to less than 2 months of age: 0.15 mg/kg
                                                                                                                                            (ii) 2 months to less than 2 years of age: 0.20 mg/kg
                                                                                                                                            (iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
                                                                                                                                            (iv) 2 years of age and older weighing 20 kg or more: 5 mg
                                                                                                                                            In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
                                                                                                                                            1 unit where (i) applies;
                                                                                                                                            2 units where (ii)