Cotter (A Child), R (On the Application Of) v The National Institute for Health And Care Excellence (NICE) & Anor (Rev 1)

For a technology to be appraised under NICE’s Highly Specialised Technology procedure, all seven lawful criteria in the 2017 Guidance must be satisfied. Falling within the statutory definition of a highly specialised health technology is necessary but does not create a presumption of appraisal under that procedure.

The Guidance must be interpreted objectively, in its NHS and statutory context. “Highly specialised service” is a technical NHS expression. It refers to a service commissioned nationally by NHS England and included in the Highly Specialised Services List, not merely a service delivered by highly specialist clinicians. A technology intended for use in a service that does not meet that description fails the relevant criterion.

The claimant, an 11-year-old child with phenylketonuria, challenged NICE’s decision to assess Kuvan under the standard Health Technology Appraisal procedure rather than the Highly Specialised Technology procedure.

The High Court dismissed the judicial review claim: [2020] EWHC 435 (Admin). The appeal concerned the interpretation of three criteria in NICE’s 2017 Guidance, the relevance of the statutory framework, and whether treatment of responsive patients constituted treatment in the context of a highly specialised service.

1. Appeal dismissed. Lord Justice Males delivered the substantive judgment. Lord Justices Phillips and Bean agreed. NICE was entitled to conclude that Kuvan did not satisfy all the criteria for the Highly Specialised Technology procedure.
2. Interpretation of the Guidance. The meaning of a non-statutory policy document is a question for the court. It must be interpreted objectively from its language, read in its proper context, and not as if it were a statute or contract. The court applied the approach in Tesco Stores Ltd v Dundee City Council [2012] UKSC 13, [2012] PTSR 983. The application of the Guidance to facts remains primarily for NICE, subject to public law review.
3. Statutory context. The definition of a highly specialised health technology in Regulation 2 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 was necessary but insufficient for HST appraisal. The seven criteria in the 2017 Guidance were cumulative. The statutory framework did not create a presumption that technologies for conditions listed in Schedule 4 to the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 must use the HST procedure.
4. Criterion 4. In its NHS context, “highly specialised service” was a technical term referring to a service commissioned nationally by NHS England and included in the Highly Specialised Services List. It was distinct from “highly specialist”, which described the expertise delivered by a service. PKU services were specialist and commissioned by NHS England, but were not nationally commissioned as highly specialised services. Criterion 4 was therefore not satisfied.
5. Criterion 2. Males LJ expressed the better view, although it was unnecessary to the result, that patients responsive to Kuvan formed a clinically accepted subgroup. A treatment trial did not prevent the group from being distinct for clinical reasons where responsiveness was assessed by a recognised clinical measure. Criterion 2 would therefore have been satisfied.
6. The court preferred not to determine criterion 1. Since criterion 4 was not satisfied and all criteria were cumulative, that issue could not affect the result. The appeal was dismissed, with no order as to costs apart from detailed assessment of the appellant’s publicly funded costs.

1. Court of Appeal (Civil Division): The appeal was dismissed. The application for permission to appeal to the Supreme Court was refused: [2020] EWCA Civ 1037.
2. High Court of Justice, Queen’s Bench Division, Administrative Court: Mr Justice Cavanagh dismissed the judicial review claim: [2020] EWHC 435 (Admin).