Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets

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; AND

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.