Document ID: chunk:federal_register_of_legislation:F2024L01397:schedule:1
Version: federal_register_of_legislation:F2024L01397
Segment Type: schedule
Provision Reference: sch 1
Character Range: 2307–4964

Schedule 1—Amendments

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

     1.            Schedule 1, Part 1, entry for Avelumab
        1.            omit from the column headed "Circumstances": C8947 C10023
        2.            insert in numerical order in the column headed "Circumstances": C16053 C16085

     1.            Schedule 1, Part 2, entry for Avelumab [Maximum Amount: 1200 mg; Number of Repeats: 8]
       omit from the column headed "Purposes": P8947 substitute: P16053

     1.            Schedule 1, Part 2, entry for Avelumab [Maximum Amount: 1200 mg; Number of Repeats: 11]
       omit from the column headed "Purposes": P10023 substitute: P16085

     1.            Schedule 3, Part 1, omit entry for Circumstances Code "C8947"

     2.            Schedule 3, Part 1, omit entry for Circumstances Code "C10023"

     3.            Schedule 3, Part 1, after entry for Circumstances Code "C15832"
       insert:
C16053  P16053  Avelumab  Stage IV (metastatic) Merkel Cell Carcinoma                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16053

                          Initial treatment

                          The treatment must be the sole PBS-subsidised therapy for this condition; AND

                          The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction; OR

                          The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.

                          The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C16085  P16085  Avelumab  Stage IV (metastatic) Merkel Cell Carcinoma                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16085

                          Continuing treatment

                          The treatment must be the sole PBS-subsidised therapy for this condition; AND

                          Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

                          Patient must not have developed disease progression while being treated with this drug for this condition; AND

                          The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction; OR

                          The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.