Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential impact of NICE's severity modifier on the availability of Enhertu for patients with secondary breast cancer.

The National Institute for Health and Care Excellence (NICE) considered the impact of its severity modifier as part of its appraisal of Enhertu for HER2-low metastatic breast cancer. However, even with the severity weighting applied, NICE concluded that the treatment was not cost-effective at the price offered by the company and therefore could not recommend it for routine National Health Service use.

The Department recognises the disappointment this decision caused for patients and the breast cancer community, particularly as Enhertu is the only breast cancer treatment that NICE has been unable to recommend for NHS use in the last eight years. In light of NICE’s updated cost-effectiveness threshold, NICE, NHS England, and the manufacturers have resumed discussions to explore whether a commercial agreement can be reached that would make Enhertu available to NHS patients.