Question to the Department of Health and Social Care:

To ask His Majesty's Government what estimate they have made of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.

HER2‑low breast cancer is managed with treatments for HER2‑negative breast cancer. The National Institute for Health and Care Excellence (NICE) has published guidance recommending a number of medicines for the treatment of HER2-negative breast cancer which are now available for the treatment of National Health Service patients in line with NICE’s guidance.

Trastuzumab deruxtecan (Enhertu) is the first licensed treatment for HER2‑low metastatic or unresectable breast cancer. The Government recognises how disappointing it was for all those affected that NICE was unable to recommend Enhertu for use in the treatment of HER2-low metastatic or unresectable breast cancer. This was because, at the price offered by the company in 2024, the treatment was too expensive for the benefits it provided, and NICE concluded it was not cost effective. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. It is estimated that approximately 1,000 to 1,500 people would have been eligible for treatment with Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy, had NICE been able to recommend it.

As part of the United States and United Kingdom partnership, announced in April 2026, NICE is now using a new higher cost-effectiveness threshold. The update to the NICE cost effectiveness threshold has already made a direct difference for NHS patients with several treatments, including treatments for cancer, that may not have been recommended under the previous threshold. Given these new circumstances, discussions involving NICE, the manufacturers, and NHS England have resumed to try to seek an agreement on a commercial offer that would make Enhertu cost-effective.

The Department has made no assessment on the of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.