Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p300
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 300/476)
Character Range: 2742712–2749235

A pharmacist, nurse or asthma educator.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) details of the proposed prescription; 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).
                                                                                                                                            The following must be provided at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and
                                                                                                                                            (b) details (date and duration of treatment) of prior biological medicine treatment; and
                                                                                                                                            (c) the IgE results and date; and
                                                                                                                                            (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and
                                                                                                                                            (e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
Onasemnogene abeparvovec                                               C12639                                                               Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                                            Use in a patient untreated with disease modifying therapies for this condition
                                                                                                                                            The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
                                                                                                                                            The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
                                                                                                                                            Patient must have experienced at least two of the defined signs/symptoms of Type 1 SMA specified below; OR
                                                                                                                                            The condition must be pre‑symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; 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.
                                                                                                                                            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
                                                                                                                                            Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND
                                                                                                                                            Patient must be undergoing treatment with this pharmaceutical benefit