Ministers will be able to direct the cost‑effectiveness thresholds that the National Institute for Health and Care Excellence (NICE) applies in technology appraisals and highly specialised technology evaluations from 24 March 2026, under the National Institute for Health and Care Excellence (Amendment) Regulations 2026. The instrument was made on 2 March and laid before Parliament on 3 March; it extends to England and Wales. The Department of Health and Social Care (DHSC) confirmed the policy intent and timetable in its consultation outcome published on 3 March 2026. (gov.uk)
The change inserts a ministerial power of direction into regulations governing NICE’s technology appraisal and highly specialised technology programmes (regulations 7 and 8 of the 2013 Regulations). Government material frames the threshold as a public policy decision about how much of the health budget should be apportioned to new treatments, while reiterating that ministers cannot direct the substance of NICE’s recommendations. (gov.uk)
The Regulations also create a targeted exception to NICE’s duty to consult. Where NICE must change its procedures solely to give effect to a ministerial direction on cost‑effectiveness thresholds, the statutory obligation to consult does not apply. DHSC notes this does not remove NICE’s discretion to consult on implementation where appropriate. (gov.uk)
DHSC’s five‑week consultation, which closed on 13 January 2026, received 203 responses spanning industry, patient groups, NHS bodies and individuals. A majority of business respondents supported the proposals, while 76% of all respondents opposed removing consultation requirements on procedural changes; written comments most frequently raised risks of political interference and to NICE’s independence. (gov.uk)
NICE has already set out how it will handle in‑train evaluations ahead of any threshold change, running a general consultation from 16 to 30 January 2026. DHSC’s response confirms the intention to proceed, with the statutory instrument due to take effect in March 2026. (nice.org.uk)
Once the power is in force and exercised, NICE indicates it will apply an updated standard cost‑effectiveness range of £25,000–£35,000 per QALY, up from £20,000–£30,000, and estimates this could enable an additional three to five medicines or indications to be recommended each year. Operational changes are expected from April 2026, subject to ministerial direction. (nice.org.uk)
Government has limited the new power to threshold‑setting only. Other elements of NICE methodology-such as discount rates or perspective-remain for NICE to determine within its statutory framework; DHSC characterises the threshold itself as a matter for democratic accountability. (gov.uk)
DHSC also plans to update the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG) to reflect any changes to the threshold, signalling alignment between assessment thresholds and commercial arrangements for branded medicines. (gov.uk)
The instrument is signed by Dr Zubir Ahmed MP, Parliamentary Under‑Secretary of State at the Department of Health and Social Care. His ministerial portfolio covers health innovation and safety. (gov.uk)
For NHS England commissioners and integrated care boards, the immediate operational issue is timing. Guidance finalised between late March and April may be issued under two different thresholds depending on when any direction is made. NICE has signalled how it will manage ongoing topics to avoid perverse outcomes, and organisations with appraisals in this window should anticipate rapid recalibration of incremental cost‑effectiveness and, where relevant, commercial arrangements. (nice.org.uk)
Geographically, the Regulations extend to England and Wales. In practice, the statutory funding requirement attaches to NHS England for technology appraisals and highly specialised technologies, while Wales and Northern Ireland typically take NICE guidance into account through their own arrangements. (gov.uk)
Analysis: The reform centralises political accountability for the affordability benchmark while shortening process‑change timelines in a narrow class of cases. DHSC also emphasises that any ministerial decision must be fair and reasonable in public law and that the prohibition on directing the substance of NICE’s guidance remains in place. (gov.uk)