Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p21
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 21/31)
Character Range: 68796–73130

to commencing treatment with this drug for this condition; AND
                      The treatment must be the sole PBS-subsidised therapy for this condition; AND
                      Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
                      Patient must be undergoing treatment with this drug class for the first time; OR
                      Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.
                      A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
                      Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.

         (c)           insert in numerical order after existing text:
   C14741  P14741     High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                      Initial first-line maintenance therapy (BRCA1/2 gene mutation)
                      The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND
                      Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; AND
                      Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
                      Patient must be undergoing treatment with this drug class for the first time; OR
                      Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.
                      A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
                      Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.
   C14742  P14742     High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                      Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)
                      Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND
                      Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                      The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.
   C14743  P14743     High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                      Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)
                      The condition must be