This paper is a companion piece to a detailed background paper on the use of real-world evidence in coverage decisions developed for the ICER Policy Summit held in December 2017.
This paper presents a new conceptual framework to address three elements largely missing from these earlier efforts focused on defining “best practices” or “standards” for RWE:
- How to understand the role that contextual factors play in determining how high the evidentiary standard, or “bar” will be in each situation;
- How to tailor key process and methodological approaches to the height of that evidentiary bar; and
- How to ensure that broader process principles that support transparency are integrated successfully throughout the course of any RWE initiative.