Proposed changes to the UK regulations on setting cost-effectiveness threshold by NICE

The National Institute for Health and Care Excellence (NICE) is the executive, non-departmental public body sponsored by the Department of Health and Social Care (DHSC) that develops authoritative, evidence-based guidance for the health and care system to support best practice and secure the best use of the health and care system’s resources.

In developing its guidance, NICE evaluates treatments against a cost-effectiveness threshold and its methods and decisions center on whether a specified product is a clinically and a cost-effective use of the health budget compared to other potential uses of that budget.

On December 9, 2025, the DHSC launched a consultation on the government’s proposals to amend the NICE and the Health and Social Care Information Centre Regulations (2013) as follows:

• Giving ministers a limited power of direction to set the standard cost-effectiveness threshold that NICE uses in the development of guidance, including technology appraisal and highly specialised technology evaluation recommendations;
• Removing the requirement for NICE to consult on changes to its procedures where these result from a ministerial direction.

The proposed change would give ministers limited power to set the relevant cost-effectiveness threshold through secondary legislation, while preserving NICE’s independence to develop the methods that it uses in developing its guidance. The proposals balance the need for democratic accountability for decisions that have significant implications for NHS resource allocation and wider government objectives with independent evidence-based decision making. 

NICE’s independence to develop its guidance and recommendations within the established framework remains critical and there are no plans to change the existing provisions that prohibit ministers from directing NICE as to the substance of its guidance and recommendations.

Comments on proposed changes can be submitted online by January 13, 2026.

See the full details here.

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