NICE’s new 25K-30K CE threshold: an important shift for the pharmaceutical industry
NICE has confirmed it will increase its cost-effectiveness (CE) threshold for Technology Appraisals from £20,000–£30,000 to £25,000–£35,000 per QALY. This change, stemming from the UK-US Economic Prosperity Deal, was presented to the NICE Board at its public meeting on Wednesday [1].
It remains unclear whether adjustments to the thresholds for Highly Specialised Technologies (HSTs) for ultra-rare diseases are under consideration; NICE will seek advice on this from the Department of Health & Social Care (DHSC).
This unprecedented rise in the NICE CE threshold is an important change that should increase patient access to innovative medicines. NICE predicts it will allow access to 3-5 more treatments or indications per year [2]. Coupled with a proposed 3-year 15% cap on the VPAG rebate, which is significantly lower than the 22.5% rebate for 2025, and comparable with the recently confirmed 14.5% rebate for 2026 [3]; this is the most meaningful change to promote access in recent years and will bring greater certainty for the pharmaceutical industry until 2028.
What happens next?
A consultation [4] has been launched (on 9th December) by the government to introduce powers enabling them to set the new CE threshold. Following which, NICE will initiate a consultation on how the change will be implemented.
In the interim, NICE have stated that any ongoing appraisals will continue to current timelines. However, for ongoing appraisals with scheduled committees prior to NICE implementing the new threshold, if products are not cost effective at the current threshold but would be considered cost effective at the new threshold, the publication of final draft guidance will be paused until NICE can apply the new thresholds (anticipated April 2026 at the earliest) [5]. At that time, NICE will proceed to publication. There is no intention to review historical guidance [5].
The anticipated timeline (subject to consultation) [4]:
Dec 2025 – DHSC consult on proposed regulations change
Early 2026 – In anticipation of regulations change, prior to March, NICE plan to conduct a short consultation on how the change will be implemented
March 2026 - Regulation change gives DHSC power to direct NICE on threshold
March 2026 – NICE directed to implement new threshold
April 2026 – NICE methods Manual updated
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References
https://www.nice.org.uk/about-us/our-board/public-board-meetings
https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-confirmed
Written by Gaia Geraci
Decisive Dialogue 12th December 2025