Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the NHS commercial framework for new medicines, updated on 29 January 2025, what assessment he has made of the potential impact of the requirement to provide value at or below the National Institute for Health and Care Excellence cost-effectiveness threshold on access to treatments for (a) rare and (b) ultra-rare diseases.

Indication-specific pricing can support access to treatments, including for rare conditions, by enabling companies to propose a specific price for smaller indications that would otherwise be commercially unviable under a uniform price.

In January 2025, following public consultation, NHS England published an updated NHS Commercial Framework for New Medicines, setting out their approach for assessing the eligibility of medicines with multiple indications to qualify for indication-specific pricing.

The National Institute for Health and Care Excellence (NICE) has been able to recommend many medicines licensed for the treatment of rare and very rare diseases through its standard technology appraisal process which are now available to National Health Service patients in England. In addition, NICE operates a separate Highly Specialised Technologies evaluation programme for medicines that meet specific criteria for very rare conditions. This programme applies a higher cost-effectiveness threshold than standard appraisals to support access to treatments for very rare conditions.

As set out in the Life Sciences Sector plan, we will be introducing a new and proportionate approach to NICE appraisals and NHS indication-specific based pricing agreements for medicines with large numbers of indications, strong long-term outcome data, and low affordability risk.

The NHS Commercial Framework encourages early and open dialogue between companies and NHS England where indication-specific pricing or other commercial flexibilities may be needed to support access to treatments. NHS England is open to providing early guidance on such arrangements and to working with companies to explore suitable commercial options.