Developing evidence that is fit for purpose: a framework for payer and research dialogue

Abstract

Objectives: Matching the supply and demand of evidence requires an understanding of when more evidence is needed, as well as the type of evidence that will meet this need. This article describes efforts to develop and refine a decision-making framework that considers payers' perspectives on the utility of evidence generated by different types of research methods, including real-world evidence.

Study design: Conceptual framework development with subsequent testing during a roundtable dialogue.

Methods: The framework development process included a literature scan to identify existing frameworks and relevant articles on payer decision making. The framework was refined during a stand-alone roundtable in December 2013 hosted by the research team, which included representatives from public and private payers, pharmacy benefit management, the life sciences industry, and researchers. The roundtable discussion also included an application of the framework to 3 case studies.

Results: Application of the framework to the clinical scenarios and the resulting discussion provided key insights into when new evidence is needed to inform payer decision making and what questions should be addressed. Payers are not necessarily seeking more evidence about treatment efficacy; rather, they are seeking more evidence for relevant end points that illustrate the differences between treatment alternatives that can justify the resources required to change practice. In addition, payers are interested in obtaining new evidence that goes beyond efficacy, with an emphasis on effectiveness, longer-term safety, and delivery system impact.

Conclusions: We believe that our decision-making framework is a useful tool to increase dialogue between evidence generators and payers, while also allowing for greater efficiency in the research process.