Reflection and Reaction http://neurology.thelancet.com Vol 6 October 2007 843 NICE judgment: good law risks bad science On August 10, 2007, at the Royal Courts of Justice, Mrs Justice Dobbs 1 ruled in favour, on most counts, of the decision by the UK National Institute for Health and Clinical Excellence (NICE) on the provision of acetylcholinesterase inhibitors to patients with Alzheimer’s disease. The plaintiffs in this case were the pharmaceutical company Eisai (one of the manufacturers of the acetylcholinesterase inhibitors) and, as interested parties, the Alzheimer’s Society and Shire Pharmaceuticals. The legal challenge was not about the decision by NICE—the body that develops guidance to cover all aspects of health care within the National Health Service (NHS)—and the NHS not to fund certain treatments for Alzheimer’s disease, nor about the cost of this treatment. The challenge was made on the basis of three grounds: discrimination, irrationality, and procedural unfairness. We wish to comment on Mrs Justice Dobbs’ ruling on procedural unfairness, which favoured NICE. We believe that, although robust, the judgment undermines the critical excellence that underpins science. Mrs Justice Dobbs ruled that NICE did not breach procedural fairness when they provided only a “read only” version—rather than a fully executable version—of the economic model on which they based their decision. Her reasons for this were: (1) that policy was to supply a read-only version of the model unless the assessment team permitted otherwise; (2) that there was no requirement for consultees to see every document; (3) that because only two members of the appraisal committee had access to the fully executable version, Eisai was in a similar position to other members of the appraisal committee; (4) that the model’s assumptions were disclosed; (5) that the information disclosed allowed for trenchant criticism, and the model was run with alternative assumptions, and its output was comparable with the output from Eisai’s alternative model with the same or similar assumptions; (6) that Eisai’s submission to the appeal panel set out why it was not possible to understand the model yet also detailed reasons why reliance on the model was perverse (which suggested an understanding of the model); (7) that no other body alleged unfairness in relation to the read- only version; (8) that no other consultee asked for a fully executable version. NICE, however, requires an executable version of every health economic model submitted to it by health technology assessment teams or consultees. The reasons for this are so that NICE can make robust checks on implementation, run sensitivity analyses, make between-model comparisons, and enable additional outputs from the model, which might be needed for the most astute scientific scrutiny. If the health economic model is wrong because it is too simplistic or it is marred We have no conflicts of interest. 1 Gros-Louis F, Gaspar C, Rouleau GA. Genetics of familial and sporadic amyotrophic lateral sclerosis. Biochim Biophys Acta 2006; 1762: 956–72. 2 Klein RJ, Zeiss C, Chew EY, et al. Complement factor H polymorphism in age- related macular degeneration. Science 2005; 308: 385–59. 3 Frayling TM. Genome-wide association studies provide new insights into type 2 diabetes aetiology. Nat Rev Genet 2007; 8: 657–62. 4 McPherson R, Pertsemlidis A, Kavaslar N, et al. A common allele on chromosome 9 associated with coronary heart disease. Science 2007; 316: 1488–91. 5 Easton DF, Pooley KA, Dunning AM, et al. Genome-wide association study identifies novel breast cancer susceptibility loci. Nature 2007; 447: 1087–93. 6 van Es MA, Van Vught PW, Blauw HM, et al. ITPR2 as a susceptibility gene in sporadic amyotrophic lateral sclerosis: a genome-wide association study. Lancet Neurol 2007; 6: 869–77. 7 Schymick JC, Scholz SW, Fung HC, et al. Genome-wide genotyping in amyotrophic lateral sclerosis and neurologically normal controls: first stage analysis and public release of data. Lancet Neurol 2007; 6: 322–28. 8 Dunckley T, Huentelman MJ, Craig DW, et al. Whole-genome analysis of sporadic amyotrophic lateral sclerosis. N Engl J Med 2007; 357: 775–88 9 van de Leemput J, Chandran J, Knight MA, et al. Deletion at ITPR1 underlies ataxia in mice and spinocerebellar ataxia 15 in humans. PLoS Genet 2007; 3: e108. Neil Hunt, the Chief Executive of the Alzheimer’s Society, speaks to the press outside the High Court regarding the judgment given on NHS restrictions on Alzheimer’s drugs on August 10, 2007, in London, UK. This case is the first time that NICE guidance has been taken to judicial review. Cate Gillon/Getty Images