Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p311
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 311/312)
Character Range: 17461340–17469007

P16279         CN16279          Temazepam                                                              For prescribing by certain health practitioners
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.
C16280              P16280         CN16280          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 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 7 doses under this restriction.
C16282              P16282         CN16282          Selpercatinib                                                          Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 16282
                                                                                                                           The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; AND
                                                                                                                           Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           Patient must be initiating treatment with this drug. or
                                                                                                                           Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.
                                                                                                                           Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.
                                                                                                                           Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.
C16285              P16285         CN16285          Saxagliptin with dapagliflozin                                         Diabetes mellitus type 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance