Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p113
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 113/161)
Character Range: 14400008–14407046

Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
                                                                                   The condition must be diagnosed by optical coherence tomography; or
                                                                                   The condition must be diagnosed by fluorescein angiography; AND
                                                                                   Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or
                                                                                   Patient must have failed prior treatment with VEGF inhibitors; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                   Authority approval for initial treatment of each eye must be sought.
                                                                                   The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include
                                                                                   (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
                                                                                   (a) A completed authority prescription form; and
                                                                                   (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (a) A completed authority prescription form; and
                                                                                   (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                   All reports must be documented in the patient's medical records.
C13432              P13432         CN13432          Pembrolizumab                  Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 13432
                                                                                   Continuing treatment - 3 weekly treatment regimen
                                                                                   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 total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.
C13433              P13433         CN13433          Nivolumab                      Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 13433
                                                                                   Initial combination treatment (with ipilimumab) as first-line drug therapy
                                                                                   The condition must be squamous type non-small cell lung cancer (NSCLC); AND
                                                                                   Patient must not have previously been treated for this condition in the metastatic setting; or
                                                                                   The condition must have progressed after treatment with tepotinib; 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 be in