Ministers to be granted power to set NICE cost thresholds

Ministers will be granted formal powers to set the National Institute for Health and Care Excellence (NICE) cost-effectiveness thresholds used to assess medicines, the government has confirmed.

The Department of Health and Social Care (DHSC) said that it did not consider that any concerns raised during a five-week consultation, launched in December 2025, should ‘materially change the proposals that were consulted on’.

It said that the government will proceed with the following changes to NICE regulations:

• Give ministers ‘limited power of direction’ to set the NICE cost-effectiveness threshold for new medicines and medical technology;
• Remove the requirement for NICE to consult publicly before implementing ministerial directions on the threshold.

Under current regulations the threshold can only be changed by a decision of the NICE board, with the government having no legal power to direct NICE to amend this.

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The government's decision comes despite more than half of the 203 consultation responses (57%) saying they disagreed with the proposal that ministerial power of direction should be limited to NICE’s standard cost-effectiveness threshold.

The DHSC also said that the free text responses showed that a ‘considerable number’ of respondents did not disagree that the power should be limited but disagreed with the proposal for a power of direction altogether.

Two-in-five of the written responses (40%) were concerned about political interference and other concerns included threats to NICE’s independence and the need for any decisions on changes to the threshold to be evidence based, the DHSC added.

It said: ‘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 [technology appraisal] and HST [highly specialised technology] guidance.’

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The government also recognised the broad opposition to removing the requirement for NICE to consult publicly before implementing ministerial directions on the threshold.

But it added: ‘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 consultation was launched after the government announced the NICE cost-effectiveness threshold would increase as part of a UK-US trade deal.

In early December the DHSC confirmed that NICE will apply new thresholds of £25,000-£35,000 per quality-adjusted life year (QALY), a 25% increase from the current range of £20,000-£30,000 that has been in place since 1999.

NICE confirmed the move, but in a Q&A on its website, when asked if it will have to consult to change the manual, NICE said 'the details of how this change will be made will be confirmed in due course'.

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The threshold increase was presented as part of a wider economic agreement with the US that includes 0% tariffs on UK pharmaceutical exports worth at least £5bn a year for three years.

The aim of the deal is to expand NHS access to vital drugs, safeguard medicine supply chains and drive investment, the government said.