(R5) Bridging the Gap: Development of Real-World Evidence (RWE) Standards to Facilitate Communication Between Manufacturers and Payers through the AMCP RWE Initiative

Real-world evidence (RWE), generated from real-world data (RWD), is gaining prominence in health care research as a source of information that reflects the diversity of patients treated under usual clinical care. According to the FDA, RWD is defined as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” that may include data from electronic health records, claims, registries, or other sources such as wearable devices and other digital health technologies. RWE, then, is the evidence derived from analysis of RWD.

Under AMCP, the AMCP Research Institute has launched a new RWE Initiative to develop a set of RWE standards that will facilitate efficient communication and ensure that RWE produced by pharmaceutical manufacturers meets the expectations and needs of payers and formulary decision-makers. To achieve this goal, focus groups have been convened, and a national survey was conducted to gather input on knowledge, experience, and best practices for using RWE in decision-making. The focus groups engaged payers, formulary experts, and representatives from pharmaceutical manufacturers to explore the use of RWE in decision-making processes, the types of RWE that are most informative, and the barriers and facilitators to incorporating RWE.

Faculty will discuss the findings from the focus groups and survey, provide insights on different types of RWE, and describe an initial framework and emerging RWE standards, along with future goals to support RWE in managed care.