Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p21
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 21/69)
Character Range: 336287–348047

C12045              P12045         Cetuximab                                                                    Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 12045
                                                                                                                Initial treatment
                                                                                                                Patient must have RAS wild‑type metastatic colorectal cancer; AND
                                                                                                                Patient must have a WHO performance status of 2 or less; AND
                                                                                                                The condition must have failed to respond to first‑line chemotherapy; OR
                                                                                                                The condition must have progressed following first‑line treatment with pembrolizumab for dMMR mCRC; AND
                                                                                                                The treatment must be as monotherapy; OR
                                                                                                                The treatment must be in combination with chemotherapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
                                                                                                                Patients who have progressive disease on panitumumab are not eligible to receive PBS‑subsidised cetuximab.
                                                                                                                Patients who have developed intolerance to panitumumab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised cetuximab.
C12066              P12066         Panitumumab                                                                  Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 12066
                                                                                                                Initial treatment
                                                                                                                Patient must have RAS wild‑type metastatic colorectal cancer; AND
                                                                                                                Patient must have a WHO performance status of 2 or less; AND
                                                                                                                The condition must have failed to respond to first‑line chemotherapy; OR
                                                                                                                The condition must have progressed following first‑line treatment with pembrolizumab for dMMR mCRC; AND
                                                                                                                The treatment must be as monotherapy; OR
                                                                                                                The treatment must be in combination with chemotherapy; AND
                                                                                                                The treatment must be the sole PBS‑subsidised anti‑EGFR antibody therapy for this condition.
                                                                                                                Patients who have progressive disease on cetuximab are not eligible to receive PBS‑subsidised panitumumab.
                                                                                                                Patients who have developed intolerance to cetuximab of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised panitumumab.
C12271              P12271         Durvalumab                                                                   Unresectable Stage III non‑small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 12271
                                                                                                                Continuing treatment
                                                                                                                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 be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
                                                                                                                The treatment must not exceed 12 months in total for this condition under the initial and continuing restriction combined; AND
                                                                                                                The treatment must be once in a lifetime with this drug for this condition.
C12470              P12470         Cetuximab                                                                    Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 12470
                                                                                                                Continuing treatment
                                                                                                                The treatment must be in combination with PBS‑subsidised encorafenib for this condition.
C12483              P12483         Cetuximab                                                                    Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 12483
                                                                                                                Initial treatment
                                                                                                                The treatment must be in combination with PBS‑subsidised encorafenib for this condition.
C12559              P12559         Gemtuzumab ozogamicin                                                        Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Induction treatment
                                                                                                                Patient must have confirmed CD33‑positive AML prior to initiation of treatment; AND
                                                                                                                The condition must be de novo; AND
                                                                                                                The condition