olaparib (Lynparza)

following a resubmission assessed under the ultra-orphan and end of life process:

olaparib (Lynparza®) is accepted for use within NHS Scotland.

Indication under review: monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Olaparib was assessed in a phase II randomised, placebo-controlled study of patients with high grade serous, recurrent, platinum-sensitive ovarian, fallopian-tube or primary peritoneal cancer in which there had been an objective response to the most recent platinum-based chemotherapy regimen. In a pre-planned analysis of the sub-group of patients with BRCA mutation, olaparib was associated with a significantly improved progression-free survival compared with placebo. An interim analysis of overall survival in the BRCA mutation sub-group (70% maturity) demonstrated a benefit of more than four months for olaparib over placebo.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of olaparib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.