Consultation outcome

Changes to NICE regulations: cost-effectiveness threshold - government response

Updated 3 March 2026

Introduction

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.

NICE plays a critical role in ensuring that limited health and care resources deliver maximum health benefit for patients while also maintaining the UK’s position as a world-leading destination for developing and launching innovative new technologies.

In developing its guidance, NICE evaluates treatments against a cost-effectiveness threshold and its methods and decisions centre 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 9 December 2025, the government launched a 5-week consultation, seeking views on proposals to amend the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 (the NICE regulations) to grant a power to the Secretary of State for Health and Social Care to direct NICE with respect to the standard cost-effectiveness threshold that it uses in the development of its guidance and recommendations. The proposed amendments to the NICE regulations are as follows:

• give ministers a limited power of direction to set the core cost-effectiveness threshold that NICE uses in the development of guidance, including technology appraisal and highly specialised technology evaluation recommendations
• remove the requirement for NICE to consult on methods changes where these result from a ministerial direction

This document summarises the responses to the consultation, sets out the government’s response to the feedback received and outlines the policy decisions reached. The intention is for the amendment to the NICE regulations to be made by a statutory instrument that comes into force in March 2026.

Summary of responses

The consultation used an online public survey that was published on GOV.UK. The consultation was open for 5 weeks and closed on 13 January 2026. A link to the survey was published in the weekly Department of Health and Social Care External Affairs bulletin, which is sent by email to 1,450 stakeholders, including workforce and system partners, charities, regulators and patient representative organisations.

The survey consisted of 3 closed questions (quantitative) relating to the proposals, with standardised response options (agree, disagree, neither agree nor disagree, don’t know), which were mandatory to answer. Each of these questions had an associated free text box (qualitative) where respondents could explain their answers (optional). There was also a final free text response section at the end of the survey for any additional comments (optional). The consultation attracted responses from a broad range of interested parties, including the pharmaceutical industry, patient groups, NHS bodies, academics and members of the public.

A total of 203 complete responses were received. Of these:

• 80 (39%) were from individuals sharing their professional views (‘professionals’). Of these, 75% indicated that they worked in the public sector
• 76 (37%) were responses on behalf of an organisation (‘organisations’). Of those respondents who indicated the type of organisation they were responding on behalf of, 49% were representing the views of a business and 39% were representing the views of a not-for-profit organisation. Other organisations included trade associations and public sector bodies
• 47 (23%) were from individuals sharing their personal views (‘individuals’)

When asked whether the proposed ministerial power of direction should be limited to NICE’s standard cost-effectiveness threshold, 57% of respondents selected ‘disagree’. However, the free text responses showed that a considerable number of these respondents did not disagree that the power should be limited, as per the question, but disagreed with the proposal for a power of direction altogether. 40% of written responses cited concerns about political interference; other concerns included potential threats to NICE’s independence and the need for any decisions on changes to the threshold to be evidence based. There were several written responses calling for a broadening of the ministerial power of direction, so that it could be applied to other parts of NICE’s methodology, such as to direct NICE to change the discount rate that is used in the economic evaluations of NICE-appraised treatments, or to allow for a broader economic perspective beyond direct costs to the health and care system.

Around half (53%) of respondents disagreed that the power to direct NICE about the standard cost-effectiveness threshold should apply to all NICE guidance that makes recommendations on health spending. The written responses disagreeing with this proposal most frequently cited concerns regarding the risk of political interference and potential threats to NICE’s independence. The vast majority (89%) of respondents who indicated that they were responding on behalf of a business agreed with the proposals, with the need for consistency across NICE’s work programmes frequently mentioned in their written responses.

76% of respondents disagreed that NICE should not be required to consult on any proposed changes to its procedures that are necessary as a result of a ministerial direction, with 37% of written responses mentioning that stakeholders and/or the public should be allowed to share their views on such proposals. There were also concerns from several respondents regarding potential negative impacts on NICE’s reputation if it did not consult, and the potential undermining of public trust and democratic accountability. 15% of respondents agreed that NICE should not be required to consult, with written responses in favour of this proposal stating that it could avoid delays in NICE’s processes and allow for quicker access to new treatments.

The ‘data analysis’ section gives a more in-depth evaluation of the responses to each question, including any additional comments received.

Government response

The government has considered the consultation responses and will proceed with implementing the proposed changes to the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 (the NICE regulations), which will:

• give ministers a limited power of direction to set the cost-effectiveness threshold that NICE uses in the development of its technology appraisal (TA) and highly specialised technology (HST) evaluation recommendations
• remove the requirement for NICE to consult on methods changes where these result from a ministerial direction on cost-effectiveness thresholds

We acknowledge the concerns raised in the consultation responses regarding potential political interference in NICE’s work and methods, and the need for NICE to remain an independent body. The government considers that the cost-effectiveness threshold that NICE uses in its evaluations is a matter of public policy, reflecting the amount of the healthcare budget that should be apportioned to innovative new treatments, taking into account a range of factors. As such, the ministerial power of direction will be limited to set only the cost-effectiveness threshold that NICE uses in the development of TA and HST guidance.

Several responses to the consultation called for the ministerial power of direction to be broadened to allow for ministers to direct NICE on other aspects of its methodology (for example, to consider a broader economic perspective in its evaluations). The policy intention is for the power of direction to safeguard NICE’s independence as it will only provide for ministers to be able to direct NICE on elements of its methodology that are a matter of public policy and for the elected government to make decisions on. The ability for NICE to set its other methods and processes independently of ministers and in an evidence-based way is vitally important and NICE will remain responsible for setting these in line with the Health and Social Care Act 2012 and associated regulations.

The consultation responses expressed broad opposition to the removal of the requirement for NICE to consult on methods changes where these result from a ministerial direction. We consider that where ministers direct NICE to change the cost-effectiveness threshold it uses in its evaluations, NICE could not meaningfully consult on the substance of this change, as it would undermine the position that determining the cost-effectiveness threshold is a decision for the elected government.

However, there were several responses, particularly from those responding on behalf of a business, that expressed a desire for NICE to be able to consult specifically on the implementation, and not the substance, of such changes to its methods. Removal of the requirement for NICE to consult would not remove its discretion to do so, and it may be appropriate for NICE to consult on the implementation of a direction from ministers to change the threshold. In fact, in January 2026, NICE launched its consultation on its proposed implementation approach to managing ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds.  

Any decisions taken by ministers must conform to the law governing public administration and must therefore be fair and reasonable. As such, the government intends to engage as appropriate with interested parties and stakeholders in any future use of the ministerial power of direction.

Additionally, the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG) will be updated to reflect any changes to the standard cost effectiveness threshold used by NICE that arise from the use of the ministerial power of direction.

Conclusion

In making its decisions, the government has thoroughly considered the responses to the consultation. As set out above, we do not consider that any concerns raised in the consultation responses should materially change the proposals that were consulted on. As such, the government will proceed with changes to the NICE regulations, to give ministers a limited power of direction to set the cost-effectiveness threshold that NICE uses in the development of its TA and HST evaluation recommendations and to remove the requirement for NICE to consult on methods changes where these result from a ministerial direction on cost-effectiveness thresholds.

Data analysis 

This section provides a breakdown of the responses to each of the questions in the survey, including the main themes that arose from the free text responses for each question.

We would like to note that there were some minor data quality concerns where the response to the initial quantitative question (agree or disagree) did not align with the associated qualitative response received from some respondents, specifically for the first question concerning the proposed limitation to the ministerial power of direction. However, we consider that the thematic analysis of qualitative responses has allowed for the overall sentiment to the proposals to be derived and accounted for in decision making.

Proposal 1

Do you agree or disagree that a ministerial power of direction, as outlined under proposal 1 above, should be limited to the NICE standard cost-effectiveness threshold?

Of the 203 responses to this question:

• 48 respondents (24%) agreed
• 115 respondents (57%) disagreed
• 33 respondents (16%) neither agreed nor disagreed
• 7 respondents (3%) didn’t know

Table 1: breakdown of responses by respondent category

Respondent category	Agree	Disagree	Neither agree or disagree	Don’t know
Professionals	14	49	13	4
Organisations	27	32	15	2
Individuals	7	34	5	1

For organisations specifically, the majority (62%) of respondents who indicated that they were responding on behalf of a business, disagreed with the proposal to limit a ministerial power of direction to the NICE standard cost-effectiveness threshold. Those in support of a broader application of the power cited how it may increase the attractiveness of the UK market and allow for alignment with wider government objectives, namely:

• the government commitment to increase new medicines spend to 0.6% of gross domestic product (GDP) in the next 10 years
• 10 Year Health Plan and Life Sciences Sector Plan commitments
• alignment with NHS priorities

Around half (55%) of respondents who indicated that they were responding on behalf of a not-for-profit organisation, agreed that the power of direction should be limited, with 22% disagreeing.

Of those respondents who provided a qualitative response to this question, 40% expressed concerns about political interference in NICE’s methods. Other concerns included threats to NICE’s independence and the need for any decisions on changes to the threshold to be evidence based. 

There were several responses calling for the power to be applied to other parts of NICE’s methodology, specifically regarding: 

• the relaxation of opportunity cost neutrality principles in decision making
• reduction of the discount rate
• allowing a broader perspective beyond health and social care costs or direct health costs

There were broad concerns about the effects on NHS budgets and/or redistribution of public funds if the ministerial power was used to increase the cost-effectiveness threshold, and the potential net loss of population health as a result. 

Do you agree or disagree that the power to direct NICE about the standard cost-effectiveness threshold should apply to all NICE guidance that makes recommendations on health spending?

Of the 203 responses to this question:

• 70 respondents (34%) agreed
• 107 respondents (53%) disagreed
• 20 respondents (10%) neither agreed nor disagreed
• 6 respondents (3%) didn’t know

Table 2: breakdown of responses by respondent category

Respondent category	Agree	Disagree	Neither agree or disagree	Don’t know
Professionals	14	54	9	3
Organisations	50	17	7	2
Individuals	6	36	4	1

Responses to this question were polarised, with most respondents either supporting the power to apply the threshold to all NICE guidance or to none of it. Consistent with the consultation responses as a whole, opinions tended to be divided between those responding on behalf of businesses, and members of the public sharing their personal or professional views, with the vast majority of responses from industry representatives agreeing with the proposal.

Several respondents who thought that the power should be applied to all NICE guidance wrote that it would avoid inequities in access, ensure consistency across all NICE programmes and reduce uncertainty for industry.

For those who opposed the power altogether, the most cited reasons were concerns that it would be a threat to NICE’s independence and the risk of political interference in NICE’s decision-making processes.

Many respondents specifically mentioned which of NICE’s work programmes, in addition to the standard TA programme, they thought that ministers should have the power to direct the cost-effectiveness threshold of. In most cases, this was the HST programme, to avoid disadvantaging people with rare diseases. The second most mentioned programme was HealthTech.

Several respondents mentioned desires for safeguards to be put in place so that ministers could not over-exert their powers. A smaller number of responses called for transparency and accountability.

Some respondents mentioned concerns regarding implications for other bodies. Most frequently this was the potential impact on the NHS. A couple of respondents mentioned implications for the Joint Committee on Vaccination and Immunisation (JCVI), calling for vaccines programmes to be considered in any decision making.

Proposal 2

Do you agree or disagree that NICE should not be required to consult on any proposed changes to its procedures that are necessary as a result of a ministerial direction on cost-effectiveness thresholds?

Of the 203 responses to this question:

• 29 respondents (14%) agreed
• 155 respondents (76%) disagreed
• 15 respondents (7%) neither agreed nor disagreed
• 4 respondents (2%) didn’t know

Table 3: breakdown of responses by respondent category

Respondent category	Agree	Disagree	Neither agree or disagree	Don’t know
Professionals	12	61	5	2
Organisations	8	60	6	2
Individuals	11	34	2	0

The majority of respondents disagreed that NICE should not be required to consult, most frequently citing the need for stakeholders and the public to be able to share their views on any proposals. 

Many respondents thought that consultations aid transparency and that to not consult could undermine public trust and democratic accountability. The reputational risk to NICE if it did not consult was also frequently mentioned. Several respondents thought that the threshold could not be seen in isolation from NICE’s other methods, and that consulting would help to avoid any unintended consequences.

Some respondents said that any consultation should focus on the implementation of changes to the cost-effectiveness threshold. Some also commented that it is good practice to consult and that it should be a requirement of all regulators and/or health technology assessment bodies.

15% of respondents agreed that NICE should not be required to consult, most commonly citing how it could speed up access to treatments. A few respondents thought that consultations should not be required for simple or procedural changes, or that the time spent consulting should be proportionate to the change being made.

Additional comments

The additional comments covered a broad number of themes, often not directly relating to the proposals outlined in the consultation document. A lot of the additional comments displayed a negative sentiment towards the proposals, with concerns over political interference in NICE being a dominant theme, although many respondents presented a balanced view of both the potential pros and cons of the proposals. 

Many respondents identified additional parts of NICE’s methodology that they thought needed to be addressed. Most commonly, this was the gap, or ‘cliff edge’, between thresholds for TA and HST, and the need for NICE to consider the wider economic and societal impacts of medicines in its appraisals. 

There were a broad range of concerns over the potential redirection of NHS budgets or increased public expenditure if ministers used a power of direction to increase the cost-effectiveness threshold, including potential increases in health inequalities as a consequence. 

Of those respondents who held a positive view of the proposals, reasons given included a view that this is an overdue change to NICE’s methods, and that the proposals would increase the attractiveness of the UK life sciences market and would lead to improvements in medicines access.

Several respondents thought that there should be better consultation on changes to NICE’s methods and there were several requests for an impact assessment to be published for any future changes to the threshold.

Many respondents named specific areas of the commercial environment that they thought still needed to be addressed, namely: 

• challenges regarding adoption
• investment into research infrastructure and clinical trials
• the need for a focus on rare disease medicines in the UK Rare Diseases Framework
• ministerial direction over NHS England’s commercial framework to remove the ‘at or below’ principle
• a commitment to eliminate the VPAG rebate in a future scheme

Several responses displayed concerns that industry is being prioritised over patients, and concerns over wider NHS impacts, specifically potential disparities in access, or health inequalities that may arise if the power of direction was used. 

Although threats to NICE’s independence was identified as a core theme, many responses identified broader, potential negative effects on NICE’s reputation, namely surrounding:

• its credibility
• the perceived fairness and transparency of its decision making
• the importance of NICE’s evidence-based approach