NICE Cost-Effectiveness Threshold: What Has Changed Six Months On?

Nov 13, 2026 | Pharma, Regulatory

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Written by: LSDN Editorial Team
On behalf of: Life Science Daily News

The NICE cost-effectiveness threshold rose on 31 March 2026, the first increase in more than two decades. Six months on, early data suggest appraisal committees are using the wider range in full. Recommendation rates have risen, and fewer companies are walking away from appraisals. However, the samples are small, and health economists still question who bears the cost.

For medicines appraised by NICE, the standard range moved up by £5,000 at each end. It went from £20,000 to £30,000 per quality-adjusted life year (QALY) gained to £25,000 to £35,000. The government agreed the change on 1 December 2025 as part of the UK-US pharmaceutical deal. That arrangement also secured a 0% tariff on UK pharmaceutical exports to the US for at least three years.

How the NICE Cost-Effectiveness Threshold Was Changed

The change required new law. Until 2026, the health secretary had no legal power to direct NICE on its threshold. The Department of Health and Social Care (DHSC) therefore ran a consultation. It proposed amending NICE’s regulations and ran from 9 December 2025 to 13 January 2026. It published its response on 3 March 2026 and laid the amending regulations the same day.

The National Institute for Health and Care Excellence (Amendment) Regulations 2026 came into force on 24 March 2026. They give ministers a limited power to direct NICE on the standard threshold. They also remove NICE’s duty to consult on procedural changes that follow such a direction. NICE then updated its manual, and the government confirmed the new range took effect on 31 March 2026.

The transitional pause for borderline topics

NICE explained how it would treat appraisals caught mid-process in a statement of intent dated 20 February 2026. A pause applied only where a committee had met, or would meet before the direction arrived. The technology also had to fall short at the old threshold. In addition, the company had to indicate that the new range could support a positive recommendation.

Once the ministerial direction arrived, NICE raised the committee’s maximum acceptable ratio by £5,000 without further discussion. Topics that still fell short received negative guidance as usual. NICE described the approach as transitional.

How Committees Have Used the Wider Range

ISPOR Europe 2026 took place in Vienna from 8 to 11 November. Two posters from the congress show the new NICE cost-effectiveness threshold in practice. Sam Bean, Solen Monteil and Charlie Hewitt of Remap Consulting reviewed positive or optimised recommendations made from 1 April 2026. They compared 12 such appraisals with 13 from April to June 2025.

Exact ratios are confidential, so the team used each final draft guidance to locate the accepted figure within the range. Under the new range, 25% of appraisals sat at the upper end, compared with 15% before. One appraisal (8%) was accepted above the range, against none in the earlier group. Meanwhile, the share at the lower end fell from 31% to 17%.

The authors concluded that committees appear to be applying the full £25,000 to £35,000 range. They also found evidence that committees will exceed the old £30,000 ceiling where it is justified.

Recommendations Up, Non-Submissions Down

A second poster, from Rebecca Andrews and Richard Macaulay of Precision AQ, examined single technology appraisal outcomes. They compared the periods either side of the change with earlier baselines. Between 24 March and 25 June 2026, 54 appraisals produced a recommendation rate of 42.3% on their measure. That compared with 33.0% across 2025 and 36.2% across 2023 to 2025.

Terminations caused by manufacturers not submitting evidence fell to 19.2%, against 24.2% in 2025. According to the authors, non-submissions fell for the first time in three years. They suggested the higher willingness to pay may have eased industry concern about US most favoured nation pricing.

By contrast, the months between announcement and implementation looked weaker. From 1 December 2025 to 24 March 2026, the recommendation rate was 23.3%. Non-submission terminations reached 26.7% over the same period. The authors linked this to companies holding back submissions and to NICE pausing borderline topics. They cautioned that the samples were small and that monitoring must continue.

Non-submission matters because it had been rising. IQVIA analysts reported an average annual termination rate of 18.95% between 2019 and 2025. That was more than double the 8.95% average between 2008 and 2018. Most terminations, 87.8%, involved companies submitting no evidence at all.

The Industry Count: Nine Medicines in Three Months

The Association of the British Pharmaceutical Industry (ABPI) has gone further. Its 2026 competitiveness report, published on 10 September 2026, credits the change with nine additional approvals. It states these medicines were approved in England and Wales between April and June 2026.

NICE had projected that the new NICE cost-effectiveness threshold would add three to five medicines or indications a year. It already recommends about 91% of the medicines it evaluates, roughly 70 a year. The ABPI figure is an industry attribution. A search on 12 November 2026 found no NICE count of approvals driven by the new threshold.

Dr Richard Torbett, chief executive of the ABPI, struck a cautious note in the report’s foreword. He wrote that the sector’s recovery “is not yet secure”.

Vorasidenib and the Cases That Test the Change

Vorasidenib (Voranigo), from Servier Laboratories, illustrates the shift. NICE’s draft guidance in October 2025 did not recommend the brain tumour drug. On 31 March 2026, final draft guidance recommended it within the Cancer Drugs Fund. It covers people aged 12 and over with IDH1 or IDH2 mutated astrocytoma or oligodendroglioma after surgery.

The Pharmaceutical Journal reported vorasidenib as one of the first two cancer drugs approved after the NICE cost-effectiveness threshold rose. Its cost-effectiveness ratio remains confidential, so the threshold’s exact role cannot be confirmed. Even so, Dr Karen Noble, director of research, policy and innovation at Brain Tumour Research, linked the two. “We are already seeing the impact of this shift,” she said. The Brain Tumour Charity estimates that about 300 people in England may be eligible.

The Alzheimer’s drugs donanemab (Kisunla) and lecanemab (Leqembi) present a sterner test. NICE’s final draft guidance in June 2025 rejected both as too costly for their benefit. Following an appeal, the appraisal returned to NICE on 20 March 2026. The committee was asked to look again at carer quality of life and unpaid care costs.

A committee meeting was first scheduled for 10 June 2026. An Eisai spokesperson told The Pharmaceutical Journal that it expected the increased thresholds to apply. The committee met on 8 July 2026. According to NICE, Eisai then accepted the committee’s assumptions as the basis for commercial talks with NHS England. Lilly had yet to do so, and no decision deadline had been set. A search on 12 November 2026 found no published outcome.

The Opportunity Cost Argument

The change has not won over every health economist. On announcement day, Professor Karl Claxton of the University of York called it “a catastrophe for all NHS patients”. His concern is displacement. Money spent on new medicines is money not spent on other NHS care.

Mike Paulden of the University of Alberta set out the arithmetic in PharmacoEconomics in January 2026. He cited UK studies estimating that each £6,000 to £15,000 spent on new medicines removes about one QALY elsewhere. On that basis, a medicine near the old £30,000 ceiling could displace roughly twice the health it provides.

Dr Huseyin Naci of the London School of Economics questioned the access argument itself. He said raising the threshold “won’t necessarily mean more drugs become available for patients”. The Office of Health Economics, however, welcomed a formal mechanism for changing the threshold. Its authors argued that any ministerial power should be narrowly defined.

The government rejected the displacement concern at the time. Wes Streeting, then health secretary, said in December 2025 that NHS services would not be cut to fund the change.

VPAG, Quality of Life Scoring and the Wider Package

The higher NICE cost-effectiveness threshold was one part of a broader settlement. Under the voluntary scheme for branded medicines, known as VPAG, the newer medicines payment rate fell to 14.5% for 2026. It had been 22.9% in 2025. The government has capped the headline rate at 15% until the scheme ends on 31 December 2028.

Ministers have also committed to raise spending on innovative medicines from 0.3% to 0.6% of GDP over ten years. According to the ABPI, interim targets are 0.35% by 2028 and 0.4% by 2030.

A second methods change may cut the other way for some products. On 27 August 2026, NICE published an interim methods statement confirming it will adopt the EQ-5D-5L value set. Treatments that extend survival tend to look more cost-effective under the new scoring. Those that improve quality of life without extending it tend to look less so. An ABPI review of 71 past appraisals found some medicines could lose access or face restrictions.

What the NICE Cost-Effectiveness Threshold Has Not Changed

Several limits remain. NICE does not routinely revisit negative decisions, so earlier rejections stand. A company can request a new appraisal only where there is good reason, such as significant new evidence.

The highly specialised technologies programme for ultra-rare conditions keeps its separate threshold of £100,000 to £300,000 per QALY. NICE has also said it is awaiting government detail on extending the change to its HealthTech and guideline work. In Scotland, the Scottish Medicines Consortium does not use a fixed threshold. The ABPI says it has nonetheless recognised the new range.

What to Watch Next

The six-month evidence is encouraging for industry but thin. Both ISPOR analyses relied on small samples and on ratios inferred from published guidance. Full-year data will show whether the rise in recommendations holds and whether non-submissions keep falling.

The interaction between the NICE cost-effectiveness threshold and the EQ-5D-5L switch will also shape outcomes from 2027. For now, committees are using the extra headroom. Whether the NHS can absorb the cost without displacing other care remains the open question.

    References:
    1. GOV.UK (Department for Business and Trade and Department of Health and Social Care), 2026, NHS patients and British businesses to benefit from historic changes to medicines access following pharmaceutical partnership with USA, https://www.gov.uk/government/news/nhs-patients-and-british-businesses-to-benefit-from-historic-changes-to-medicines-access-following-pharmaceutical-partnership-with-usa
    2. Department of Health and Social Care, 2026, Changes to NICE regulations: cost-effectiveness threshold (consultation outcome), https://www.gov.uk/government/consultations/changes-to-nice-regulations-cost-effectiveness-threshold
    3. NICE, 2025, Changes to NICE’s cost-effectiveness thresholds confirmed, https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-confirmed
    4. Bean S, Monteil S, Hewitt C, 2026, How have NICE committees applied the new cost effectiveness thresholds of £25,000 to £35,000 per QALY? ISPOR Europe 2026, abstract HTA238 (Value in Health 29(12S)), https://www.ispor.org/heor-resources/presentations-database/presentation-cti/ispor-europe-2026/poster-session-3-4/how-have-nice-committees-applied-the-new-cost-effectiveness-thresholds-of-25-000-to-35-000-per-qaly
    5. Andrews R, Macaulay R, 2026, Have NICE’s increased cost-effectiveness thresholds improved technology appraisal outcomes? ISPOR Europe 2026, abstract HTA319 (Value in Health 29(12S)), https://www.ispor.org/heor-resources/presentations-database/presentation-cti/ispor-europe-2026/poster-session-4-4/have-nice-s-increased-cost-effectiveness-thresholds-improved-technology-appraisal-outcomes
    6. Association of the British Pharmaceutical Industry, 2026 (published 10 September 2026), UK pharmaceutical investment competitiveness report 2026, https://www.abpi.org.uk/publications/uk-pharmaceutical-investment-competitiveness-report-2026/
    7. The Pharmaceutical Journal, 2026 (published 30 July 2026), Pharmaceutical companies in talks with NICE about access to Alzheimer’s drugs, https://pharmaceutical-journal.com/article/news/pharmaceutical-companies-in-talks-with-nice-about-access-to-alzheimers-drugs
    8. Paulden M, 2026, Economic consequences of increasing the NICE cost-effectiveness threshold, PharmacoEconomics 44(1):5-8, https://doi.org/10.1007/s40273-025-01579-9
    All content is published for informational purposes only and does not constitute medical, legal, or investment advice. For more information, see our Terms and Conditions.

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