Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p353
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 353/476)
Character Range: 3125290–3135807

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.
                                                                                                                                            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
                                                                                                                                            The condition must have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND
                                                                                                                                            The condition must be pre-symptomatic; AND
                                                                                                                                            The treatment must be given concomitantly with best supportive care for this condition; AND
                                                                                                                                            Patient must be untreated with gene therapy.
                                                                                                                                            Patient must be aged under 36 months prior to commencing treatment.
                                                                                                                                            Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:
                                                                                                                                            (a) details of the proposed prescription; and
                                                                                                                                            (b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
                                                                                                                                            (i) confirmation of genetic diagnosis of SMA; and
                                                                                                                                            (ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)
                                                                                                                                            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.
Ritonavir                                                              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
Romiplostim                                                            C13396                                                               Severe thrombocytopenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Second or Subsequent Continuing treatment
                                                                                                                                            The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            Patient must have previously