Document ID: chunk:federal_register_of_legislation:F2023L01752:schedule:1:p1
Version: federal_register_of_legislation:F2023L01752
Segment Type: schedule
Provision Reference: sch 1 (pt 1/2)
Character Range: 2265–5889

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

    [1]           Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
    omit:
         Bortezomib‑AFT  AE  MP  C11099 C13745  D

    [2]           Schedule 1, Part 1, entry for Obinutuzumab
    insert in numerical order in the column headed "Circumstances": C14764

    [3]           Schedule 1, Part 1, entry for Pembrolizumab
       (a)           omit from the column headed "Circumstances": C10687
       (b)           omit from the column headed "Circumstances": C10695
       (c)           insert in numerical order in the column headed "Circumstances: C14770 C14786

    [4]           Schedule 1, Part 2, entry for Obinutuzumab [Maximum Amount: 1000 mg; Number of Repeats: 5]
insert in numerical order in the column headed "Purposes": P14764

    [5]           Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200 mg; Number of Repeats: 7]
       (a)           omit from the column headed "Purposes": P10687 P10695
       (b)           insert in numerical order in the column headed "Purposes": P14770 P14786

    [6]           Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
    omit:
         APO‑Ondansetron ODT  TX  MP  C5743     4  0  C

    [7]           Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
    omit:
         Ondansetron APOTEX  GX  MP  C5778     4  0  C

    [8]           Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg
    omit:
         APO‑Ondansetron ODT  TX  MP  C5743     4  0  C

    [9]           Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
    omit:
         Ondansetron APOTEX  GX  MP  C5778     4  0  C

    [10]       Schedule 3
omit:
GX  Apotex Pty Ltd  52 096 916 148

    [11]       Schedule 4, entry for Obinutuzumab
  insert in numerical order after existing text:
   C14764  P14764  Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14764
                   For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapy
                   The condition must be untreated; AND
                   The treatment must be in combination with PBS-subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses).

    [12]       Schedule 4, entry for Pembrolizumab
       (a)           omit:
   C10687  P10687  Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                  Compliance with Authority Required procedures
                   Initial treatment ‑ 3 weekly treatment regimen
                   The treatment must be adjuvant to complete surgical resection; AND
                   Patient must have a WHO performance status of 1 or less; AND
                   The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                   Patient must not have received prior PBS‑subsidised treatment for this condition; AND
                   The treatment must commence within 12 weeks of complete resection; AND
                   Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy.

       (b)           omit:
   C10695  P10695  Resected Stage IIIB, Stage IIIC or