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The Department of Health and Social Care (DHSC) has confirmed that it will go ahead with changes to regulations for the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold, despite opposition to the proposals from the majority of consultation responses.
The government launched the five-week consultation in December 2025, which asked sought opinions on proposals to give ministers a limited power of direction to set the core cost-effectiveness threshold that NICE uses in the development of guidance.
It also asked for views on the removal of requirement for NICE to consult on methods changes where these resulted from a ministerial direction.
NICE has not formally increased its thresholds since its establishment in 1999.
In a statement published on 1 December 2025, ahead of the consultation launch, NICE said the adjusted threshold could allow the approval of an additional three to five medicines for use on the NHS in England each year.
It said the changes would also allow the NHS to spend £25,000 to £35,000 per quality-adjusted life year (QALY) gained by the use of a new drug, compared with the previous thresholds of between £20,000 and £30,000.
Responses to the consultation, published on 3 March 2026, revealed that 57% of 203 respondents said they disagreed with a proposal that ministerial power of direction should be limited to NICE’s standard cost-effectiveness threshold.
The government also reported that free-text responses showed that a considerable number of these respondents did not disagree that the power should be limited, but disagreed with the proposal for a power of direction altogether.
Just over half (53%) of respondents disagreed that the power to direct NICE on the standard cost-effectiveness threshold should apply to all NICE guidance that makes recommendations on health spending. Written responses disagreeing with this proposal most frequently cited concerns over the risk of political interference and potential threats to NICE’s independence.
Three-quarters (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.
Despite these results, the DHSC said it will proceed with implementing the proposed changes to the regulations.
“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,” it added.
“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 [technology appraisal] and [highly specialised technologies] guidance.
“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.”
The DHSC added that 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”.
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