gms | German Medical Science

Background: Although the Medical Research Council (MRC) framework recommends several methods for the economic evaluation of complex interventions, only some, if any, are commonly used. The majority of studies examine the cost-effectiveness of interventions, but only a minority investigates additional aspects, fully reflecting the complex nature of evidence-based interventions (EBIs). One reason for this discrepancy is the lack of comprehensive methodological guidelines for evaluating complex interventions and best-practice examples for health economic evaluation. Therefore, we aim to demonstrate the practical application of several approaches recommended by the MRC framework. The approaches presented are currently being used alongside a randomized controlled trial (RCT) investigating the effectiveness and cost-effectiveness of a complex prevention intervention for patients at high risk of psychosis.

Hypothesis: Further descriptions of the practical application of the MRC framework methods recommended for health economic evaluation of complex interventions are needed to promote their widespread use and the development of general guidelines.

Methods: The cost-effectiveness of the intervention compared to the control group is assessed in a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) with a time horizon of 12 months. We use the primary endpoint of the RCT and quality-adjusted life years (QALYs) derived from the EuroQol-5-Dimensions 3 Level as effect measures. Analyses will be conducted from a societal and payer’s perspective. In addition, we will use a cost-consequence analysis (CCA) to show further health economic consequences of the intervention and thus inform decision-makers comprehensively. To provide information beyond the stated time horizon, a health economic logic model, a dark logic model, and a system map are built as the theoretical basis for our CCA and long-term modeling.

Results: Using the example of a complex prevention intervention for patients at high risk of psychosis, we outline several approaches, in particular logic modeling, system mapping, and CCA, that could complement traditional health economic evaluation methods. We describe how we used these approaches to capture the complex nature of our intervention and its context. We also discuss their advantages and disadvantages in health economic evaluation. Finally, we describe how the results of these methods can inform the sustainability of EBIs.

Discussion: An undeniable discrepancy between the recommended standard and the actual state of economic evaluation leads to inappropriate guidance for decision-makers. This undermines the purpose of any evaluation. Consequently, guidelines for the practical application of methodologies are urgently needed to improve the quality of guidance to decision-makers, resulting in overall improvements and savings, as the effects of complex interventions are not limited to one sector.

Implications: This contribution demonstrates the practical application of some MRC framework methods to promote the further development of general health economic evaluation guidelines, so that future analyses better reflect the complex nature of the majority of EBIs.

Funding: Innovationsfonds/Versorgungsforschung; CARE, FKZ 01NVF20004