Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of the introduction of the National Care Institute for Health and Care Excellence severity modifier in 2022 on the (a) appraisal of Enhertu for HER2-low secondary breast cancer and (b) availability of new treatments for secondary breast cancer over the next (i) five, (ii) ten and (iii) twenty years.

The National Institute for Health and Care Excellence (NICE) is responsible for developing the methods and processes it uses in its evaluations independently, and in consultation with stakeholders. The severity modifier that the NICE introduced in 2022 is based on evidence of societal preferences, and was introduced as part of a comprehensive review of the NICE’s methods and processes, following extensive public and stakeholder engagement. The severity modifier was designed to be opportunity cost neutral in relation to the end of life modifier that it replaced, and to apply to a broader range of conditions than had benefited from the end of life modifier.

The NICE was unfortunately unable to recommend Enhertu (trastuzumab deruxtecan) for the treatment of HER2-low secondary breast cancer in its final guidance published in July 2024, despite the topic being awarded a severity weighting. Other drugs for advanced cancer, including breast cancer, have been approved using these methods.

No assessment has been made on the likely impact on appraisals of future breast cancer medicines. However, since its introduction, the severity modifier has resulted in a higher approval rate for cancer medicines than under the NICE’s previous methods, and has also allowed greater weight to be applied to non-cancer medicines that address a broader range of severe diseases, enabling the NICE to recommend medicines for conditions such as cystic fibrosis and hepatitis D. The NICE is keeping the impact of the severity modifier under review and is scoping further research into society’s preferences on how much additional weighting to give to health benefits for people with severe diseases.