Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to engage with the pharmaceutical industry on price negotiations relating to Enhertu; and if he will take steps to help ensure that Enhertu becomes an (a) affordable and (b) accessible treatment option for patients with HER-2 low (i) metastatic and (ii) unresectable breast cancer.

Decisions on whether new medicines should be routinely funded by the NHS 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 been able to recommend Enhertu in advanced breast cancer for treating HER2-positive unresectable or metastatic breast cancer after one or more anti-HER2 treatments, and for treating HER2-positive unresectable or metastatic breast cancer after two or more anti-HER2 therapies.

On 29 July 2024, NICE published final guidance on Enhertu for use in the treatment of HER2-low metastatic breast cancer, and it was unable to recommend this life-extending treatment. The only obstacle to access for NHS patients to Enhertu is price, and the Secretary of State met the manufacturers of Enhertu, AstraZeneca and Daiichi Sankyo, to encourage them to re-enter discussions with NHS England with a view to reaching a price at which NICE would be able to recommend Enhertu. However, despite NICE and NHS England offering unprecedented flexibility, the companies were unable to offer Enhertu at a cost-effective price. NICE’s guidance will therefore remain unchanged, however, 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.