niraparib tosylate monohydrate (Zejula)

following a full submission assessed under the end of life and orphan medicine process:

niraparib tosylate monohydrate (Zejula®) is accepted for restricted use within NHSScotland.

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

SMC restriction: to patients who do not have a germline BRCA mutation.

Niraparib was assessed in a double blind, randomised, placebo controlled phase III 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. Niraparib maintenance was associated with a significantly improved progression free survival when compared with placebo.

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

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