Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p2
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 2/69)
Character Range: 171770–184137

this drug is no longer eligible for PBS‑subsidised treatment with this drug.
C4785               P4785          Cetuximab                                                                    Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 4785
                                                                                                                Initial treatment
                                                                                                                The treatment must be in combination with radiotherapy; AND
                                                                                                                Patient must be unable to tolerate cisplatin.
C4788               P4788          Cetuximab                                                                    Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 4788
                                                                                                                Continuing treatment
                                                                                                                The treatment must be in combination with radiotherapy; AND
                                                                                                                Patient must be unable to tolerate cisplatin; OR
                                                                                                                Patient must have a contraindication to cisplatin according to the TGA‑approved Product Information.
C4793               P4793          Arsenic                                                                      Acute promyelocytic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 4793
                                                                                                                Induction and consolidation treatment
                                                                                                                The condition must be characterised by the presence of the t(15:17) translocation or PML/RAR‑alpha fusion gene transcript; AND
                                                                                                                The condition must be relapsed; AND
                                                                                                                Patient must be arsenic naive at induction.
C4794               P4794          Cetuximab                                                                    Stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 4794
                                                                                                                Initial treatment
                                                                                                                The treatment must be for the week prior to radiotherapy; AND
                                                                                                                Patient must have a contraindication to cisplatin according to the TGA‑approved Product Information.
C4908               P4908          Cetuximab                                                                    Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4908
                                                                                                                Initial treatment
                                                                                                                Patient must have RAS wild‑type metastatic colorectal cancer; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The condition must be previously untreated; AND
                                                                                                                The treatment must be in combination with first‑line chemotherapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
C4912               P4912          Cetuximab                                                                    Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4912
                                                                                                                Continuing treatment
                                                                                                                Patient must have received an initial authority prescription for this drug for first‑line treatment of RAS wild‑type metastatic colorectal cancer; AND
                                                                                                                Patient must not have progressive disease; AND
                                                                                                                The treatment must be in combination with first‑line chemotherapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
C5130                              Mesna                                                                        Urothelial toxicity
                                                                                                                Prophylaxis or reduction of toxicity
                                                                                                                The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.
C5452               P5452          Panitumumab                                                                  Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 5452
                                                                                                                Continuing treatment
                                                                                                                Patient must have received an initial authority prescription for panitumumab for first‑line treatment of RAS wild‑type metastatic colorectal cancer; AND
                                                                                                                Patient must not have progressive disease; AND
                                                                                                                The treatment must be in combination with first‑line chemotherapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
                                                                                                                Patients who have