title: Decision making by NICE: examining the influences of evidence, process and context.
abstract: The National Institute for Health and Clinical Excellence (NICE) provides guidance to the National Health Service (NHS) in England and Wales on funding and use of new technologies. This study examined the impact of evidence, process and context factors on NICE decisions in 2004-2009. A data set of NICE decisions pertaining to pharmaceutical technologies was created, including 32 variables extracted from published information. A three-category outcome variable was used, defined as the decision to 'recommend', 'restrict' or 'not recommend' a technology. With multinomial logistic regression, the relative contribution of explanatory variables on NICE decisions was assessed. A total of 65 technology appraisals (118 technologies) were analysed. Of the technologies, 27% were recommended, 58% were restricted and 14% were not recommended by NICE for NHS funding. The multinomial model showed significant associations (p ⩽ 0.10) between NICE outcome and four variables: (i) demonstration of statistical superiority of the primary endpoint in clinical trials by the appraised technology; (ii) the incremental cost-effectiveness ratio (ICER); (iii) the number of pharmaceuticals appraised within the same appraisal; and (iv) the appraisal year. Results confirm the value of a comprehensive and multivariate approach to understanding NICE decision making. New factors affecting NICE decision making were identified, including the effect of clinical superiority, and the effect of process and socio-economic factors.
authors.affiliation: 1 Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors.forename: Karin H
authors.initials: KH
authors.lastname: Cerri
authors.affiliation: 2Professor of Social Policy, Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Knapp
authors.forename: José-Luis
authors.initials: JL
authors.lastname: Fernández
authors.affiliation: 3Principal Research Fellow, Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors.forename: Jose-Luis
authors.initials: JL
authors.lastname: Fernandez
mesh_terms: D003362:Cost-Benefit Analysis; D003657:Decision Making; D004739:England; D006801:Humans; D018803:Models, Economic; D055553:Prescription Drugs / Q000191:economics*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013222:State Medicine / Q000191:economics / Q000941:ethics / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000941:ethics / Q000458:organization & administration*
chemical_list: D055553:Prescription Drugs