1 Recommendations

1.1 Tucatinib with trastuzumab and capecitabine is recommended, within its marketing authorisation, as an option for treating HER2‑positive locally advanced or metastatic breast cancer in adults after 2 or more anti‑HER2 treatment therapies, only if the company provides tucatinib according to the commercial arrangement.

Why the committee made these recommendations

Current treatment for HER2‑positive locally advanced or metastatic breast cancer after 2 or more anti‑HER2 regimens is chemotherapy. Tucatinib with trastuzumab and capecitabine (tucatinib combination) is another anti‑HER2 therapy that could be used after 2 or more anti‑HER2 regimens. Trastuzumab can be given subcutaneously or intravenously, but the subcutaneous injection is easier to administer.

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. But 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. It is likely that tucatinib combination improves people's quality of life before and after their cancer gets worse compared with chemotherapy.

The economic model does not take into account all of the benefits of tucatinib combination, particularly for people with brain metastases. Taking this into account, the cost-effectiveness estimates for tucatinib combination are likely to be within what NICE normally considers an acceptable use of NHS resources. So, tucatinib combination is recommended.

  • National Institute for Health and Care Excellence (NICE)