Cotter v NICE

When a public body applies non-statutory guidance, the court determines the guidance’s meaning objectively, in context and by reference to its language. The decision-maker retains evaluative judgment where the criteria involve questions of degree or specialist expertise.

Judicial review does not permit the court to substitute its own view. The intensity of irrationality review reflects both the decision’s impact and the decision-maker’s expertise, but irrationality remains a high threshold.

For NICE’s highly specialised technology process, a clinically distinct patient group must be identifiable before treatment, not defined only by its response to a treatment trial. “Highly specialised service” refers to the NHS commissioning model, not merely a service involving highly specialist expertise. “Very few centres” must be assessed in the context of comparable highly specialised services.

The claimant, an 11-year-old child with phenylketonuria, challenged NICE’s decision to assess sapropterin (Kuvan) under the standard health technology appraisal process rather than the highly specialised technology process.

NICE’s published guidance required all seven selection criteria for the highly specialised technology process to be satisfied. NICE concluded that three criteria were not met: the target group was not clinically distinct, the technology was not expected to be used exclusively in a highly specialised service, and treatment would not usually be concentrated in very few NHS centres.

The central issues were whether NICE had interpreted and applied those criteria lawfully and whether its conclusions were irrational.

1. The application for judicial review was dismissed. The claimant had to succeed on all three challenged criteria, and the finding on the second criterion was independently sufficient to defeat the claim.

2. The meaning of non-statutory guidance is a matter for the court. It must be interpreted objectively, according to the language used and its proper context, although it should not be construed as if it were a statute or contract. Its primary intended readership may also assist in understanding the language.

3. The intensity of irrationality review lay between the parties’ submissions. The decision had a very significant impact on patients, favouring careful scrutiny. However, the criteria required expert judgment, and NICE was institutionally better placed to make the relevant evaluations. Proper respect was therefore due to its conclusions, while the court retained its supervisory role. The threshold for irrationality remained high.

4. Criterion 2 required the target patient group to be clinically distinct before treatment. Patients identified only by a treatment trial, and by a threshold involving medical judgment, were not a clinically distinct group. The criterion served the practical purpose of enabling NICE to identify the relevant population and conduct a cost-benefit assessment in advance.

5. Criterion 4 referred to services commissioned nationally by NHS England as highly specialised services. It did not refer merely to services delivered by highly specialist practitioners or services listed as highly specialist in the relevant regulations or manual. PKU treatment was provided through specialist metabolic disorder services, not a nationally commissioned highly specialised service.

6. Criterion 1 involved a contextual value judgment as to whether treatment would usually be concentrated in very few centres. NICE was entitled to understand “very few” by reference to the number of centres in which comparable highly specialised services were normally provided. Treatment available through nine hub centres, with further spoke centres, did not satisfy the criterion. NICE had asked itself the correct question and its conclusion was not irrational.