A framework for developing RWE to inform drug coverage decisions

Understanding the Context, Selecting the Standards: 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 RWE in coverage decisions developed for 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: 1) how to understand the role that contextual factors play in determining how high the evidentiary standard, or “bar” will be in each situation; 2) how to tailor key process and methodological approaches to the height of that evidentiary bar; and 3) how to ensure that broader process principles that support transparency are integrated successfully throughout the course of any RWE initiative.