Document ID: chunk:federal_register_of_legislation:F2024L01736:schedule:1:p1
Version: federal_register_of_legislation:F2024L01736
Segment Type: schedule
Provision Reference: sch 1 (pt 1/6)
Character Range: 2253–6157

Schedule 1—Amendments

National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)
 1.                    Schedule 1, entry for Abacavir with Lamivudine
     omit:
         Abacavir/         C4527 C4528     60  5
         Lamivudine Mylan

 1.                    Schedule 1, after entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira]
     insert:
         Hyrimoz  C12120 C14061 C14063 C14064 C14107 C14136     See Schedule 2  See Schedule 2

 1.                    Schedule 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg
     omit:
         Ceptolate  C5600 C5653 C9689 C9690     600  5

 1.                    Schedule 1, entry for Risdiplam
          1.            omit from the column headed "Circumstances": C14458
          2.            insert in numerical order in the column headed "Circumstances": C16257
 1.                    Schedule 1, entry for Vedolizumab
          1.            omit from the column headed "Circumstances": C16170
          2.            insert in numerical order in the column headed "Circumstances": C16239
 1.                    Schedule 2, entry for Risdiplam [Maximum quantity: 1; Maximum repeats: 0]
          1.            omit from the column headed "Circumstances": C14458
          2.            insert in numerical order in the column headed "Circumstances": C16257
 1.                    Schedule 2, entry for Vedolizumab [Maximum quantity: 1; Maximum repeats: 2]
          1.            omit from the column headed "Circumstances": C16170
          2.            insert in numerical order in the column headed "Circumstances": C16239
 1.                    Schedule 3, entry for Risdiplam
          1.            omit:
   C14458     Pre‑symptomatic spinal muscular atrophy (SMA)                                                                                                                                                                                                                                                                                                                                                             Compliance with Written Authority Required procedures
              Initial treatment with this drug of pre‑symptomatic spinal muscular atrophy (SMA)
              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
              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) a completed authority prescription form; and
              (b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
              (i) confirmation of genetic diagnosis of