title: NICE technology appraisals: working with multiple levels of uncertainty and the potential for bias.
abstract: One of the key roles of the English National Institute for Health and Clinical Excellence (NICE) is technology appraisal. This essentially involves evaluating the cost effectiveness of pharmaceutical products and other technologies for use within the National Health Service. Based on a content analysis of key documents which shed light on the nature of appraisals, this paper draws attention to the multiple layers of uncertainty and complexity which are latent within the appraisal process, and the often socially constructed mechanisms for tackling these. Epistemic assumptions, bounded rationality and more explicitly relational forms of managing knowledge are applied to this end. These findings are discussed in the context of the literature highlighting the inherently social process of regulation. A framework is developed which posits the various forms of uncertainty, and responses to these, as potential conduits of regulatory bias-in need of further research. That NICE's authority is itself regulated by other actors within the regulatory regime, particularly the pharmaceutical industry, exposes it to the threat of regulatory capture. Following Lehoux, it is concluded that a more transparent and reflexive format for technological appraisals is necessary. This would enable a more robust, defensible form of decision-making and moreover enable NICE to preserve its legitimacy in the midst of pressures which threaten this.
authors.affiliation: Department of Sociology and Anthropology, University of Amsterdam, Oudezijds Achterburgwal 185, 1012 DK, Amsterdam, The Netherlands. p.r.brown@uva.nl
authors.forename: Patrick
authors.initials: P
authors.lastname: Brown
authors.forename: Michael
authors.initials: M
authors.lastname: Calnan
mesh_terms: D015982:Bias; D016265:Conflict of Interest; D003362:Cost-Benefit Analysis; D003657:Decision Making; D006291:Health Policy; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013222:State Medicine / Q000941:ethics* / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000941:ethics* / Q000458:organization & administration*; D035502:Trust; D006113:United Kingdom