Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p272
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 272/476)
Character Range: 2547532–2557888

resonance imaging due to the risk of physical (not psychological) injury to the patient.
                                                                                                                                            The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
                                                                                                                                            Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
                                                                                                                                            For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.
Nevirapine                                                             C4454                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4512                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naïve; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4526                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4526
                                                                                                                                            Initial
                                                                                                                                            Patient must have been stabilised on nevirapine immediate release; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
Nusinersen                                                             C12672                                                               Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment ‑ Loading doses
                                                                                                                                            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.
                                                                                                                                            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 and symptoms of SMA type I, II or IIIa prior to 3 years of age; 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 not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND
                                                                                                                                            Patient must be untreated with gene therapy.
                                                                                                                                            Patient must be 18 years of age or under.
                                                                                                                                            Defined signs and symptoms of type I SMA are:
                                                                                                                                            i) Onset before 6 months of age; and
                                                                                                                                            ii) Failure to meet or regression in