Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p345
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 345/476)
Character Range: 3070066–3077509

treatment in a child or adult, but where treatment was initiated during childhood
                                                                                                                                            Patient must be undergoing continuation of existing PBS‑subsidised treatment with this drug; OR
                                                                                                                                            Patient must be undergoing a change in prescribed SMA drug to this drug ‑ the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19th birthday for SMA type IIIB/IIIC; AND
                                                                                                                                            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 concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
                                                                                                                                            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.
                                                                                                                                            Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
                                                                                                                                            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) applies;
                                                                                                                                            3 units where (iii) applies;
                                                                                                                                            3 units where (iv) applies.
                                                                       C14408                                                               Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                            Initial PBS‑subsidised treatment with this drug in a child
                                                                                                                                            Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND
                                                                                                                                            Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC).
                                                                                                                                            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