(R1) Unlocking the Value of Real-World Evidence (RWE): Insights for Payers and Manufacturers

Real-world evidence (RWE), generated from real-world data (RWD), is transforming health care by bridging the gap between research and everyday practice. RWD refers to data collected from patients' health status and routine healthcare delivery, while RWE represents clinical insights derived from analyzing RWD. As regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) increasingly consider RWE to inform their regulatory decisions, including post-market safety monitoring and drug approvals, its national and global significance continues to grow. Most pharmaceutical companies are investing in RWE creating opportunities for payers to incorporate RWE into formulary and medical policy decision-making. Furthermore, payers are interested in using RWE as part of their decision-making process but expressed a need for more training on how to assess the quality of RWD for research purposes, evaluate RWE studies, and practically apply it to their decisions.

Through an interactive panel discussion, attendees will learn practical approaches to obtaining RWD, assessing data for quality and research purposes, generating RWE and interpreting findings, and examining diverse applications of RWE throughout the drug lifecycle, from development to post-market evaluation, offering participants a comprehensive understanding of how RWE can inform strategic decision-making.