Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting.

Economic evaluations are increasingly conducted alongside randomised controlled trials, providing researchers with individual patient data to estimate cost effectiveness.However, randomised trials do not always provide a sufficient basis for economic evaluations used to inform regulatory and reimbursement decisions. For example, a single trial might not compare all the available options, provide evidence on all relevant inputs, or be conducted over a long enough time to capture differences in economic outcomes (or even measure those outcomes). In addition, reliance on a single trial may mean ignoring evidence from other trials, meta-analyses, and observational studies. Under these circumstances, decision analytical modelling provides an alternative framework for economic evaluation. Decision analytical modelling compares the expected costs and consequences of decision options by synthesising information from multiple sources and applying mathematical techniques, usually with computer software. The aim is to provide decision makers with the best available evidence to reach a decision—for example, should a new drug be adopted? Following on from our article on trial based economic evaluations, we outline issues relating to the design, conduct, analysis, and reporting of economic evaluations using decision analytical modelling. Defining the question