Document ID: chunk:federal_register_of_legislation:F2025L00067:schedule:1:p1
Version: federal_register_of_legislation:F2025L00067
Segment Type: schedule
Provision Reference: sch 1 (pt 1/2)
Character Range: 2308–6292

Schedule 1—Amendments

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

     1.            Schedule 1, Part 1, entry for Paclitaxel, nanoparticle albumin‑bound
    insert in the columns in the order indicated, and in alphabetical order for the column headed "Brand":
         nab-PACLITAXEL JUNO  C4657 C6106 C6119

     1.            Schedule 1, Part 1, entry for Pembrolizumab
        1.            omit from the column headed "Circumstances": C13431
        2.            omit from the column headed "Circumstances": C13436
        3.            insert in numerical order in the column headed "Circumstances": C16264 C16280

     1.            Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200 mg; Number of Repeats: 6]
             1.            omit from the column headed "Purposes": P13431
             2.            insert in numerical order in the column headed "Purposes": P16280

     2.            Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400 mg; Number of Repeats: 3]
             1.            omit from the column headed "Purposes": P13436
             2.            insert in numerical order in the column headed "Purposes": P16264

     3.            Schedule 3, Part 1, omit entry for Circumstances Code "C13431"

     4.            Schedule 3, Part 1, omit entry for Circumstances Code "C13436"

     5.            Schedule 3, Part 1, after entry for Circumstances Code "C16197"
       insert:
C16264  P16264  Pembrolizumab  Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16264
                               Initial treatment - 6 weekly treatment regimen
                               Patient must not have previously been treated for this condition in the metastatic setting; OR
                               The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; AND
                               Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
                               Patient must have a WHO performance status of 0 or 1; AND
                               The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND

                               The treatment must not exceed a total of 4 doses under this restriction.
C16280  P16280  Pembrolizumab  Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16280
                               Initial treatment - 3 weekly treatment regimen
                               Patient must not have previously been treated for this condition in the metastatic setting; OR
                               The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; AND
                               Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
                               Patient must have a WHO performance status of 0 or 1; AND
                               The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an