Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps NICE will take to ensure that responses from stakeholders to the review of its methods and processes are considered as part of that review.

The National Institute for Health and Care Excellence (NICE) is an independent body responsible for the methods and processes used in the development of its recommendations.

NICE assesses the clinical and cost effectiveness of all new medicines and recommends the majority of the medicines it appraises for use in the National Health Service, including medicines for patients with rare diseases. As part of the ongoing review, NICE has given particular consideration to the suitability of its methods and processes for treatments for rare diseases. A number of the changes proposed by NICE are expected to ensure that its methods continue to support patient access to innovative medicines for patients with rare diseases.

NICE has listened to stakeholders throughout the review through a series of consultations on the case for change and proposed changes and is now carefully considering stakeholders’ responses to its latest consultation. In addition to the changes proposed in its methods review to support rare disease patients, NICE is working with the Department to contribute to development of an action plan detailing how the ‘UK Rare Diseases Framework’ can be implemented in England.