Statutory Instruments
2026 No. 202
HEALTH AND SOCIAL CARE, ENGLAND AND WALES
The National Institute for Health and Care Excellence (Amendment) Regulations 2026
Made
2nd March 2026
Laid before Parliament
3rd March 2026
Coming into force
24th March 2026
The Secretary of State makes these Regulations in exercise of the powers conferred by sections 237(1) and (2) and 304(9) and (10) of the Health and Social Care Act 2012(1).
Citation, commencement and extent
1.—(1) These Regulations may be cited as the National Institute for Health and Care Excellence (Amendment) Regulations 2026 and comes into force on 24th March 2026.
(2) These Regulations extend to England and Wales.
Amendment of the National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Information Functions) Regulations 2013
2. The National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Information Functions) Regulations 2013(2) are amended as follows.
Amendment to regulation 7
3.—(1) Regulation 7 (NICE technology appraisal recommendations) is amended as follows.
(2) After paragraph (1) insert—
“(1A) The Secretary of State may direct NICE as to the applicable cost-effectiveness threshold to apply to a health technology undergoing appraisal.”.
(3) In paragraph (9) before “NICE must” insert “Subject to paragraph (9A),”.
(4) After paragraph (9) insert—
“(9A) The obligation to consult does not apply to a change to procedures that are necessary to give effect to a direction given by the Secretary of State made under paragraph (1A).”.
(5) After paragraph (14) insert—
“(15) In this regulation and regulation 8—
“cost-effectiveness threshold” means the value, whether expressed as a single figure or a range, against which NICE evaluates the cost-effectiveness or value for money of a health technology or highly specialised health technology.”.
Amendment to regulation 8
4.—(1) Regulation 8 (NICE highly specialised technology recommendations) is amended as follows.
(2) After paragraph (1) insert—
“(1A) The Secretary of State may direct NICE as to the applicable cost-effectiveness threshold to apply to a highly specialised health technology undergoing appraisal.”.
(3) In paragraph (8) before “NICE must” insert “Subject to paragraph (8A),”.
(4) After paragraph (8) insert—
“(8A) The obligation to consult does not apply to a change to procedures necessary to give effect to a direction given by the Secretary of State made under paragraph (1A).”.
Signed by the authority of the Secretary of State for Health and Social Care.
Zubir Ahmed
Parliamentary Under Secretary of State
Department of Health and Social Care
2nd March 2026
2012 c. 7. Sections 237(1) and (2) were amended by the Health and Care Act 2022 (c. 31) section 1 and Schedule 1 paragraph 1. There are no relevant amendments to section 304.
S.I. 2013/259. The relevant amending instruments are S.I. 2022/634 and 2023/98.