The maturation of use of real-world evidence (RWE) in decision making requires substantiation and growth in several areas including data sources and catalogs, data quality, governance, analytic methods, reporting standards, transparency, replicability, and fit-for-purpose specifications.^{1, 2, 3} During the past few years, recent guidance documents from the US Food and Drug Administration, European Medicines Agency, and many other agencies and societies have begun to address these areas.^{4, 5, 6} Health technology assessment (HTA) agencies or coalitions such as the National Institute for Health and Care Excellence in the United Kingdom, European Network for Health Technology Assessment, Real-World Data in Asia for Health Technology Assessment in Reimbursement, and Canadian Agency for Drugs and Technologies in Health have also issued guidance.^{7, 8, 9, 10} Although the promulgation of guidance is a critical step toward framing the use of RWE in health-related innovation, regulation, and HTA, the actual use of RWE for these purposes is still very much in its nascency.

This Value in Health supplement elucidates the current state of practice regarding the generation and use of RWE for HTA purposes in several European countries, identifying barriers and specific suggestions for facilitating better practice. The articles were generated by the European initiative of new Reimbursement and Access Approaches (EUreCCA) 2025, a stakeholder forum of academics, policy, and payer experts funded by Novartis. This group “seeks to advance constructive engagement between healthcare system stakeholders on the growing challenges in European healthcare to bringing effective new medicines to the patients that need them, embracing both regulation and funding.” The 5 articles herein are the product of its RWE workstream.