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 decision to restrict secondary breast cancer patient's access to Enhertu on the grounds of patient wellbeing.

The National Institute for Health and Care Excellence (NICE) makes independent, evidence-based recommendations for the National Health Service in England on whether new licensed medicines should be routinely funded for eligible patients based on an evaluation of clinical and cost effectiveness.

NICE has recommended Enhertu, also known as trastuzumab deruxtecan, for use in the Cancer Drugs Fund for the treatment of women with HER2-positive secondary breast cancer and it is now available for the treatment of eligible patients while further data on its effectiveness is being collected that will inform a NICE decision on routine funding.

NICE published guidance in July 2024 on the use of Enhertu for the treatment of HER-2 low metastatic and unresectable breast cancer and was unfortunately unable to recommend it for routine NHS funding. I understand that NICE and NHS England have sought to apply as much flexibility as they can in their considerations of Enhertu for HER2-low breast cancer and have made it clear to the companies that their pricing of the drug remains the only obstacle to access.

Ministers met with the manufacturers of Enhertu, AstraZeneca and Daiichi Sankyo in November 2024, to encourage them to re-engage in commercial discussions with NHS England. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. NICE’s guidance published in July 2024 will therefore remain unchanged. NICE has reassured me that the door remains open for the companies to enter into a new NICE appraisal if they are willing to offer Enhertu at a cost-effective price.

Since January 2022, NICE has recommended all but one of the treatments for breast cancer that it has assessed. These treatments are now available to eligible National Health Service patients.