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

High grade epithelial ovarian, fallopian tube or primary peritoneal cancer

Initial subsequent-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

The condition must be platinum sensitive; AND

Patient must have received at least two previous platinum-containing regimens; AND

Patient must have relapsed following a previous platinum-containing regimen; AND

Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; 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.

Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.

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.