Document ID: chunk:federal_register_of_legislation:F2025L00222:schedule:1:p1
Version: federal_register_of_legislation:F2025L00222
Segment Type: schedule
Provision Reference: sch 1 (pt 1/4)
Character Range: 2292–6313

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (PB 31 of 2024)

      1.                    Subsection 27(3)

     omit: 99(3)(b) substitute: 99AAAB(1)(b)

      1.                    Schedule 1, Part 1, entry for Blinatumomab
      1.               omit from the column headed "Circumstances": C14587 C14588 C14631
      2.              insert in numerical order in the column headed "Circumstances": C16292 C16308 C16334 C16341

      1.                    Schedule 1, Part 2, entry for Blinatumomab [Maximum Amount: 651 mcg; Number of Repeats: 0]
     omit from the column headed "Purposes": P14588 substitute: P16292

      1.                    Schedule 1, Part 2, entry for Blinatumomab [Maximum Amount: 784 mcg; Number of Repeats: 1]
     omit from the column headed "Purposes": P14587 P14631 substitute: P16308 P16334 P16341

      1.                    Schedule 2, entry for Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain
     omit from the column headed "Form": Vial containing powder for intravesical administration approximately 5 x 108 CFU
     substitute: Vial containing powder for intravesical administration approximately 500 million CFU

      1.                    Schedule 3, Part 1, omit entry for Circumstances Code "C14587"

      2.                    Schedule 3, Part 1, omit entry for Circumstances Code "C14588"

      3.                    Schedule 3, Part 1, omit entry for Circumstances Code "C14631"

      4.                    Schedule 3, Part 1, after entry for Circumstances Code "C16280"
         insert:
C16292  P16292  Blinatumomab  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                              Induction treatment
                              The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
                              The condition must not be present in the central nervous system or testis; AND
                              Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
                              Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
                              Patient must not have received more than 1 line of salvage therapy; AND
                              The condition must be one of the following: (i) untreated with this drug for Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL), (ii) treated with this drug for Pre-B-cell ALL, but the condition has not relapsed within 6 months of completing that course of treatment; AND
                              The condition must have more than 5% blasts in bone marrow; AND
                              The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                              According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
                              An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may