Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made representations to the National Institute for Health and Care Excellence on the availability of Enhertu for patients with HER2-low breast cancer.

The National Institute for Health and Care Excellence (NICE) makes recommendations on whether new medicines should be routinely funded by the National Health Service in England independently on the basis of the available evidence of costs and benefits and through engagement with the NHS, manufacturers, patient groups and other interested parties.

The Department regularly meets with colleagues in NICE to discuss a range of issues, including Enhertu for patients with HER2-low breast cancer. However, the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 provide that Ministers must not direct NICE as to the substance of its recommendations. These are very difficult decisions to make. NICE recognises that its decisions have important implications for patients and their families and only publishes final guidance on the use of a drug after a very careful consideration of the evidence and extensive engagement with interested parties including patients and clinicians. Therefore, it would not be appropriate for Ministers to intervene.