The National Institute for Health and Care Excellence (Amendment) Regulations 2026

• Citation: S.I. 2026/202
• Sections: 4

Section 1 Citation, commencement and extent

(1) These Regulations may be cited as the National Institute for Health and Care Excellence (Amendment) Regulations 2026 and come into force on 24th March 2026.

(2) These Regulations extend to England and Wales.

Section 2 Amendment of the National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Information Functions) Regulations 2013

The National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Information Functions) Regulations 2013 are amended as follows.

Section 3 Amendment to regulation 7

(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.

Section 4 Amendment to regulation 8

(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).