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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Olaparib (alone or with endocrine therapy) is not recommended, within its marketing authorisation, for the adjuvant treatment of HER2-negative high-risk early breast cancer that has been treated with neoadjuvant or adjuvant chemotherapy in adults with germline BRCA1 or 2 mutations.

1.2 This recommendation is not intended to affect treatment with olaparib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with BRCA mutation-positive HER2-negative high-risk early breast cancer usually have chemotherapy followed by surgery (neoadjuvant chemotherapy), or surgery followed by chemotherapy (adjuvant chemotherapy).

Clinical trial evidence shows that, compared with placebo, olaparib after neoadjuvant or adjuvant chemotherapy decreases the chance of the cancer returning or getting worse, and increases the length of time people live.

But the cost-effectiveness estimates for olaparib are above what NICE considers to be an acceptable use of NHS resources. So, olaparib cannot be recommended.