Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions his Department has had with NICE on ensuring that patient access to treatment for very rare diseases is not delayed in circumstances where there is uncertainty on the incidence and prevalence of the disease by the consultation entitled Highly specialised technologies: NICE prioritisation board routing criteria.

The Department has regular discussions with the National Institute for Health and Care Excellence (NICE) about a range of issues, including the criteria for routing topics to the Highly Specialised Technologies (HST) programme.

Decisions on whether medicines should be evaluated through the NICE’s HST programme are taken by the NICE against a set of published criteria that have been developed through public and stakeholder engagement. The NICE is currently reviewing the criteria and opened a consultation in December 2024, with a closing date for comments of 30 January 2025. The proposed criteria are intended to make routing decisions more predictable and transparent with the aim of making the process more timely and efficient. We encourage people to respond to the consultation.

The NICE aims, wherever possible, to issue draft guidance on new medicines close to the time of licensing. The National Health Service in England is legally required to fund drugs recommended by the NICE, usually within three months of final guidance.