Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make representations to NICE on their decision to no longer offer Enertu for women suffering from metastatic HER2-LOW breast cancer.

Decisions on whether new medicines should be routinely funded by the National Health Service in England are taken by the National Institute for Health and Care Excellence (NICE) on the basis of an evaluation of a treatment’s costs and benefits. NICE’s methods are internationally respected, and have been developed through extensive work with industry, academics and the public to ensure they appropriately capture the costs and benefits, and best reflect social values. These are very difficult decisions to make, and it is important that they are made independently and based on the available evidence.

We understand that despite NICE instigating an exceptional pause in the process to allow for commercial negotiations to take place with the companies, Daiichi Sankyo and AstraZeneca, a deal to enable patient access to this treatment on the NHS in England has not been reached.

We know NICE’s announcement has come as a blow to many women and their families. We understand that NICE and NHS England have already sought to apply as much flexibility as they can in their considerations of Enhertu and have made it clear to the companies that their pricing of the drug remains the main obstacle to access.

Within 16 weeks of the publication of final guidance, companies can also request a rapid review to consider new patient access scheme proposals, with the aim of establishing a pricing agreement that would improve cost-effectiveness and enable patient access to high-cost medicines. The Government wants to see a deal reached to make Enhertu available. NICE and NHS England remain open to considering an improved offer from the companies through the rapid review process, and we strongly encourage the companies to come back to the table.