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.
Download detailed advice940KB (PDF)
- Medicine name:
- olaparib (Lynparza)
- SMC ID:
As monotherapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy.
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 09 October 2023