Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p20
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 20/69)
Character Range: 328325–337801

this condition; AND
                                                                                                                The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
C11985              P11985         Nivolumab                                                                    Unresectable malignant mesothelioma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 11985
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be in combination with PBS‑subsidised ipilimumab, unless an intolerance to ipilimumab of a severity necessitating permanent treatment withdrawal of ipilimumab; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                The treatment must not exceed a maximum total of 24 months in a lifetime for this condition.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C12016              P12016         Cetuximab                                                                    Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 12016
                                                                                                                Continuing treatment
                                                                                                                Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of first‑line chemotherapy; OR
                                                                                                                Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of treatment with first‑line pembrolizumab for dMMR mCRC; AND
                                                                                                                Patient must not have progressive disease; 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.
C12035              P12035         Panitumumab                                                                  Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 12035
                                                                                                                Continuing treatment
                                                                                                                Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of first‑line chemotherapy; OR
                                                                                                                Patient must have received an initial authority prescription for this drug for treatment of RAS wild‑type metastatic colorectal cancer after failure of treatment with first‑line pembrolizumab for dMMR mCRC; AND
                                                                                                                Patient must not have progressive disease; 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.
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