A Decision-Theoretic Framework for the Application of Cost-Effectiveness Analysis in Regulatory Processes

Cost-effectiveness analysis (CEA) represents the most important tool in the health economics literature to quantify and qualify the reasoning behind the optimal decision process in terms of the allocation of resources to a given health intervention. However, the practical application of CEA in the regulatory process is often limited by some critical barriers, and decisions in clinical practice are frequently influenced by factors that do not contribute to efficient resource allocation, leading to inappropriate drug prescription and utilization. Moreover, most of the time there is uncertainty about the real cost-effectiveness profile of an innovative intervention, with the consequence that it is usually impossible to obtain an immediate and perfect substitution of a product with another having a better cost-effectiveness ratio.