Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p14
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 14/381)
Character Range: 11515596–11529254

52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
C10297              P10297         CN10297          Atezolizumab                                                                                                    Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 10297
                                                                                                                                                                    Continuing treatment - 3 weekly treatment regimen
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                                                                                                    Patient must have stable or responding disease.
C10306              P10306         CN10306          Binimetinib                                                                                                     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10306
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously been issued with an authority prescription for this drug; AND
                                                                                                                                                                    Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND
                                                                                                                                                                    Patient must have stable or responding disease.
C10309              P10309         CN10309          Trifluridine with tipiracil                                                                                     Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 10309
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have a WHO performance status of 1 or less; AND
                                                                                                                                                                    Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; or
                                                                                                                                                                    Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-VEGF agent and an anti-EGFR agent for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.
C10310              P10310         CN10310          Trifluridine with tipiracil                                                                                     Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10310
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
C10317              P10317         CN10317          Darunavir with cobicistat, emtricitabine and tenofovir alafenamide                                              HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10317
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised therapy for HIV infection; AND
                                                                                                                                                                    The treatment must not be in combination with ritonavir.
C10324              P10324         CN10324          Darunavir with cobicistat, emtricitabine and tenofovir alafenamide                                              HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10324
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND
                                                                                                                                                                    Patient must be antiretroviral treatment naive; or
                                                                                                                                                                    Patient must have experienced