ISSUE: Historically, payers have been the main audience for real-world evidence (RWE) in Europe and other major markets. In recent years, however, the value of RWE has garnered greater appreciation from regulatory bodies and health technology assessment (HTA) agencies. Both the European Medicines Agency (EMA) and National Institute for Health & Care Excellence (NICE) have issued various statements, guidance documents and plans for the use of RWE in their decision making. However, payer decisions differ from those of regulators which in turn differ from those of HTAs, and this calls into question whether their perspectives on RWE are aligned.

OVERVIEW: Payer perspectives on RWE have been well chronicled in the literature: data on relative effectiveness of competing interventions in real-world use is an important complement to efficacy data from clinical trials to inform decisions regarding formulary placement and reimbursement. The regulatory perspective in Europe is evolving: in 2019, the EMA published its Operational, Technical, and Methodological (OPTIMAL) framework for use of RWE in regulatory decision making; followed this up with other strategic documents related to RWE; and recently set up a coordination center for the Data Analysis and Real World Interrogation Network (DARWIN EU), for secondary use of existing real-world data. HTA agency perspectives on RWE are coming into focus as well, with NICE releasing its RWE framework to (1) identify how and when RWE can be used to reduce uncertainties and improve guidance, and (2) describe best practices for planning, conducting and reporting RWE to improve quality and transparency. This issue panel will feature 12-minute presentations by Wim Goettsch, Peter Arlett of EMA, and Dalia Dawoud of NICE—representing the payer, regulatory, and HTA perspectives, respectively. The moderator, David Thompson, will drive an interactive discussion to identify areas of alignment and divergence across the three stakeholder perspectives, soliciting audience interaction and feedback.