Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p278
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 278/476)
Character Range: 2591768–2600811

present during childhood,
                                                                                                                                            (3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.
                                                                       C14370                                                               Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Changing the prescribed therapy
                                                                                                                                            Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient's 19thbirthday; 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.
                                                                                                                                            Patient must be untreated with gene therapy; AND
                                                                                                                                            Patient must not be receiving invasive permanent assisted ventilation 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 prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy.
                                                                       C14421                                                               Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                            Changing the prescribed therapy
                                                                                                                                            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 19thbirthday 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.
                                                                                                                                            Patient must be untreated with gene therapy; AND
                                                                                                                                            Patient must not be receiving invasive permanent assisted ventilation 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 prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy.
                                                                       C14433                                                               Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                            Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood
                                                                                                                                            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.
                                                                                                                                            Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated