Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p85
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 85/191)
Character Range: 10471548–10485303

treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C7433               P7433          CN7433           Axitinib                                                                                                                                                                   Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7433
                                                                                                                                                                                                                               Continuing treatment beyond 3 months
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                                                                               A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C7446               P7446          CN7446           Erlotinib                                                                                                                                                                  Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7446
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease;
                                                                                                                                                                                                                               Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.
C7447               P7447          CN7447           Gefitinib                                                                                                                                                                  Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 7447
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease.
C7458               P7458          CN7458           Pazopanib                                                                                                                                                                  Advanced (unresectable and/or metastatic) soft tissue sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 7458
                                                                                                                                                                                                                               Continuing treatment beyond 3 months
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
C7459               P7459          CN7459           Pazopanib                                                                                                                                                                  Advanced (unresectable and/or metastatic) soft tissue sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 7459
                                                                                                                                                                                                                               Continuing treatment beyond 3 months
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
                                                                                                                                                                                                                               Patient must require dose adjustment; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
C7471               P7471          CN7471           Sunitinib                                                                                                                                                                  Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 7471
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have disease progression; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy.
                                                                                                                                                                                                                               A patient