Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p14
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 14/20)
Character Range: 46589–50554

in the patient's medical records:
              (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and
              (b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and
              (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
              (d) the eosinophil count and date; and
              (e) Asthma Control Questionnaire (ACQ-5) score.

 1.                Schedule 3, entry for Methadone
     substitute:
Methadone  C16083     Opioid dependence                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 16083
                      The treatment must be within a framework of medical, social and psychological treatment.
                      The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

 1.                Schedule 3, entry for Onasemnogene abeparvovec
         1.            omit:
   C14468     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
              The condition must be pre‑symptomatic SMA, with genetic confirmation that there are 3 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