A systematic review of coverage decision-making on health technologies-evidence from the real world.

OBJECTIVE Quantitative analysis of real-world coverage decision-making offers insights into the revealed preferences of appraisal committees. Aim of this review was to structure empirical evidence of coverage decisions made in practice based on the components 'methods and evidence', 'criteria and standards', 'decision outcome' and 'processes'. METHODS Several electronic databases, key journals and decision committees' websites were searched for publications between 1993 and June 2011. Inclusion criteria were the analysis of past decisions and application of quantitative methods. Each study was categorized by the scope of decision-making and the components covered by the variables used in quantitative analysis. RESULTS Thirty-two studies were identified. Many focused on pharmaceuticals, the UK NICE or the Australian PBAC. The components were covered comprehensively, but heterogeneously. Seventy-two variables were identified of which the following were more prevalent: specifications of the decision outcome; the indications considered for appraisal, identification of incremental cost-effectiveness ratios, appropriateness of evaluation methods, type of economic or clinical evidence used for assessment, and the decision date. CONCLUSIONS Research was dominated by analysis of decision outcomes and appraisal criteria. Although common approaches were identified, the complexity of coverage decision-making - reflected by the heterogeneity of identified variables - will continue to challenge empirical research.