Real-world evidence (RWE) is at an important precipice to deliver improved value demonstration and differentiation of products for pharmaceutical and device companies and enhanced population-based analyses and value assessment by health plans and pharmacy benefit managers (PBMs) for both clinical and economic endpoints.

Currently, we are at this juncture in the United States as RWE has gained significant traction from increasing acceptability of RWE regulatory submissions by the US Food and Drug Administration, which released guidelines on its use in submissions with 90% of new drug approvals in the United States including RWE in 2020.¹ In addition, the utility of RWE has increased as a result of improvements in electronic medical record and claims data curation through artificial intelligence and machine learning methods, the ability to integrate all types of data with refined tokenization methods, more rigorous study methods, and the need for companies to demonstrate or evaluate value because of continued health care economic pressures.² These advancements in RWE enable the use of it to complement randomized clinical trial data and leverage the strengths of the evidence generated from each study method.

Recent surveys on US payer perspectives for the use of RWE in health care decision-making revealed that 100% of US payers feel that RWE is a critical component to wholistic value assessment, yet 0% stated that they routinely use it in their appraisals and decisions from the consequence of several factors:

As a result of these findings, AMCP has stepped up to take the lead role in improving the use of RWE in US payer health care decision-making by

Please join me in supporting this quest by AMCP for using the complete body of evidence in health care decision-making to foster how RWE can appropriately supplement evidence endpoints from randomized clinical trials.