Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p15
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 15/20)
Character Range: 50268–53816

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 once only in a lifetime; AND
              Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.
              Patient must be no older than 9 months of age.
              The authority application must be made in writing and must include:
              (1) a completed authority prescription form; 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).
              State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.
              Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:
              (i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or
              (ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.
              Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).
              Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.
   C15458     Spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
              Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen to onasemnogene abeparvovec)
              The treatment must be given concomitantly with best supportive care for this condition; 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.
              Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND
              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)