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1 Recommendations

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1 Recommendations

1.1 Tucatinib with trastuzumab and capecitabine is not recommended, within its marketing authorisation, for treating HER2-positive locally advanced or metastatic breast cancer in adults after at least 2 prior anti-HER2 treatment regimens.

1.2 This recommendation is not intended to affect treatment with tucatinib with trastuzumab and capecitabine 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

Current treatment for HER2‑positive locally advanced or metastatic breast cancer after 2 or more anti‑HER2 regimens includes chemotherapy, such as capecitabine, vinorelbine or eribulin. Tucatinib with trastuzumab and capecitabine (from now, tucatinib combination) is another anti‑HER2 therapy that could be used after 2 or more anti‑HER2 regimens.

Clinical trial evidence shows that tucatinib combination increases the time people have before their cancer gets worse and how long they live compared with trastuzumab with capecitabine. However, trastuzumab with capecitabine is not standard care in the NHS. Comparing tucatinib combination indirectly with chemotherapy suggests it may increase the time people have before their cancer gets worse and how long they live. But the extent of benefit is uncertain because of differences between the trials.

The cost-effectiveness estimates for tucatinib combination are higher than what NICE normally considers an acceptable use of NHS resources. Therefore, it is not recommended.