Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has made an assessment of the potential merits of increasing the accessibility of Enhertu as a treatment for breast cancer.

Decisions on whether new medicines should be routinely funded by the National Health Service in England are made on the basis of recommendations from the National Institute for Health and Care Excellence (NICE) following an evaluation of a treatment’s costs and benefits. These are very difficult decisions to make, and it is important that they are made independently and on the basis of the available evidence.

NICE has recommended Enhertu (trastuzumab deruxtecan) in advanced breast cancer for treating HER2-positive unresectable or metastatic breast cancer after one or more anti-HER 2 treatments and for treating HER2-positive unresectable or metastatic breast cancer after two or more anti-HER2 therapies. Enhertu is now funded for eligible patients in England in line with NICE’s recommendations.

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 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. Although the deadline for a rapid review has now passed, 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.