A Framework to Guide the Optimal Development and Use of Real World Evidence for Coverage and Formulary Decisions

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.

Click here to read the white paper on ICER’s website!