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 potential merits of developing new NICE criteria for rare conditions that do not meet the 300 patient threshold for the Highly Specialised Technology appraisal system.

Decisions on whether medicines should be evaluated through the National Institute for Health and Care Excellence’s (NICE) highly specialised technologies (HST) programme are taken by NICE itself against a set of published criteria that have been developed through public and stakeholder engagement.

NICE recently reviewed and consulted on updates to its HST criteria and the refined criteria have been implemented since April 2025. The purpose of the review was not to change the number or nature of the topics that are evaluated through the HST Programme, but to ensure that the criteria are sufficiently clear and predictable for companies and patient groups and are aligned to the HST vision.

There are currently no plans for NICE to develop new criteria for conditions that do not meet the 300-patient threshold outlined in the current HST criteria. However, NICE’s standard medicines evaluation process has been proven to be suitable for the evaluation of rare disease medicines, where companies are willing to price their medicines fairly.

NICE’s approval rate for medicines for rare diseases is in line with its overall approval rate for new medicines. Between April 2024 and April 2025, NICE recommended all 15 of the rare disease drugs that it evaluated through its standard technology appraisal programme, which are now available for the treatment of NHS patients.