Explanatory note

These Regulations amend the National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Functions) Regulations 2013 (S.I. 2013/259) (“2013 Regulations”). The purpose of these amendments is to introduce a power for the Secretary of State to direct the National Institute of Health and Care Excellence (“NICE”) with regard to the cost-effectiveness threshold NICE is to apply to health technologies when carrying out technology appraisals under regulation 7 of the 2013 Regulations or appraising highly specialised health technologies under regulation 8 of the 2013 Regulations.

Regulation 3 amends regulation 7 of the 2013 Regulations to introduce a power of direction to specify the cost-effectiveness threshold NICE must apply to technology appraisals it carries out. Regulations 3(3) and (4) introduce amendments that relieve NICE of its obligation to consult under regulation 7(9) of the 2013 Regulations where relevant changes to procedures are necessary to give effect to a direction concerning the cost-effectiveness threshold.

Regulation 4 amends regulation 8 of the 2013 Regulations to introduce a power of direction to specify the cost-effectiveness threshold NICE must apply to highly specialised health technology appraisals it carries out. Regulations 4(3) and (4) introduce amendments that relieve NICE of its obligation to consult under regulation 8(8) of the 2013 Regulations where the relevant changes to procedures are necessary to give effect to a direction concerning the cost-effectiveness threshold.

An impact assessment relating to this instrument has been prepared and copies can be obtained from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU and is available on the www.legislation.gov.uk website.