Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent discussions officials in his Department have had with representatives from (a) NICE and (b) NHS England on the potential merits for rare disease patients of the proposed changes to accepting greater uncertainty, as set out in NICE’s ongoing review of its methods and processes.

The Department regularly discuss a range of issues with colleagues in the National Institute for Health and Care Excellence (NICE) and NHS England and NHS Improvement, including NICE’s methods review. However, NICE is an independent body and is responsible for its own methods and processes.

NICE has consulted on a range of proposals although it is too soon to comment on the changes that may be implemented. However, NICE expects to consult on the draft programme manual in the summer, with implementation of the changes from early 2022. NICE and NHS England and NHS Improvement are working together on the development of proposals for the Innovative Medicines Fund. We expect NHS England and NHS Improvement and NICE to lead an engagement exercise later this year. A detailed timescale for this will be confirmed in due course.