olaparib (Lynparza)

following a full submission assessed under the orphan medicine process:

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

Indication Under Review: as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have human epidermal growth factor receptor 2 (HER2)-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

In a phase III study, adjuvant olaparib after the completion of neoadjuvant or adjuvant chemotherapy, significantly improved invasive disease-free survival compared with placebo in patients with high-risk, HER2-negative early breast cancer with a germline BRCA1/2-mutation.

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.

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