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 adequacy of the availability of Enhertu for the treatment of (a) HER2-positive and (b) HER2-low breast cancer.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations for the National Health Service on whether new licensed medicines should be routinely funded by the NHS based on 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 based on the available evidence. The NHS in England is legally required to fund medicines recommended by NICE.

NICE has been able to recommend Enhertu 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 2 or more anti-HER2 therapies. Enhertu is now available for NHS patients in line with NICE’s recommendations.

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 my Rt. Hon. Friend, the Secretary of State for Health and Social Care, 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 for the moment. However, NICE remains open to being as flexible as possible with commercial partners and are willing to enter into a new NICE appraisal if there is movement on pricing.