olaparib (Lynparza)

following an abbreviated submission:

olaparib (Lynparza®) is accepted for restricted use within NHSScotland.

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

SMC restriction: patients with BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Olaparib hard capsules were previously accepted for use within NHS Scotland under the ultra-orphan and end of life process as 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 film-coated tablets will replace olaparib capsules, which are to be discontinued.

Olaparib film-coated tablets demonstrated higher bioavailability compared to olaparib capsules and therefore a dose adjustment is required when switching from capsules to film-coated tablets.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.