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][2005][2006][2007][2008][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.

Still Elegantly Muddling Through? NICE and Uncertainty in Decision Making About the Rationing of Expensive Medicines in England

“…48 Limitations: This study explored the decision-making across the three of the four committees which might be significant as it became evident that each of the committees -making heavily influenced by the chair, suggesting that there may be variations in recommendations by committee. Cerri and colleagues 13 found in their statistical analysis that a large majority of technological two s and one conditional or restricted yes, suggesting that the appraisals included in our study might not be typical. However, in the pilot and feasibility stages of this research a number of other technological appraisal meetings were observed and the process, at the least, appeared to be similar to those that were observed in the main study.…”

“…Certainly, the extent of information provided seems to create further complexities rather than resolving uncertainty and straightforwardly facilitating rational decision making. 42 There was common recognition that some forms of uncertainty were ignored and not addressed, as they could not be managed and that, in order to reach a decision, deliberations ultimately needed to focus down on a relatively small number of issues, with wider potentially problematic There was evidence of a plurality of legitimate perspectives for evaluating evidence, decisions and outcomes but calculative approaches in NICE decision making were particularly emphasised in the discussions on the strength of the evidence to support cost effectiveness 13 and thus the uncertainties related to that issue were paramount. One primary concern was whether the drug manufacturers analysis had been carried out using the most appropriate methodology and addressed the salient pre-agreed appraisal questions and whether the submission was transparent and accessible enough to be critically assessed.…”

“…The STA process relies on manufacturerprovided information 13 This threshold has become an explicit and formal norm but appears not to have a rational basis. Decision making is primarily consensual although on some occasions voting is used in the last resort.…”

“…11,12 Evidence from statistical analyses suggests that while the demonstration of clinical and economic value is central to NICE decisions, the variability in these decision-outcomes about whether they recommend a technology or not can also be explained by other process and socio-economic factors. 13 This may be due, at least in part, to the very nature of bureaucratic judgements amidst uncertainty, where reliance on and correspondingly trust in people and systems is unavoidable. 14 Whether it is confidence in research paradigms and approaches, trust in expert panels, or weighing up the evidence presented by different expert patients, leading clinicians, or drug company representatives a range of sociallyconstructed assumptions, might influence attributions of validity, competency and/or motives, 15 which could bear decisively on appraisal decisions.…”

Cost Effectiveness of a Pharmacist-Led Information Technology Intervention for Reducing Rates of Clinically Important Errors in Medicines Management in General Practices (PINCER)

“…Some cross-country variations are explained by considerations of therapeutic value [24], disease severity [25] and economic considerations [22,26,27]. Clinical considerations have been shown to be significant predictors of funding recommendations in Canada, the UK and Poland [28][29][30][31], with clinical uncertainty being significant in Belgium and Wales [32,33] and not significant in Scotland [34]. Cost effectiveness was a significant influence on funding recommendations in all countries except Wales [33].…”