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 exercise by the National Institute for Health and Care Excellence of its discretionary power to show flexibility in relation to its (a) Standard Technology Appraisal and (b) Highly Specialised Technologies programme routing decisions in circumstances where there is (i) uncertainty on the incidence and prevalence of the disease and (ii) high unmet clinical need to ensure fair and equitable access to innovative new treatments for patients living with rare diseases.

The Department has regular discussions with the National Institute for Health and Care Excellence (NICE) about a range of issues, including about the delivery of public commitments. The NICE will consult on proposed changes to its criteria for highly specialised technology appraisals in 2024/25.

We have made no assessment of the extent to which the NICE has demonstrated flexibility in making decisions on whether new medicines should be routed to its highly specialised technologies (HST) programme. Decisions on whether topics should be routed to the HST programme are taken independently of the Department by the NICE’s Prioritisation Board, in line with the routing criteria set out in the NICE’s published prioritisation framework, and through engagement with experts and other interested parties. The board’s decisions are published on the NICE’s website.

This Government is aware of the challenges facing those living with rare diseases, including access to specialist care, treatment, and medicines. The NICE is actively monitoring the impact of the changes that it made to its methods and processes in 2022 on the availability of medicines for rare diseases, and is planning to publish a report by the end of 2024.