The Real-World Evidence Workstream In EUreccA 2025: How the task was addressed.

This is the second in a series of papers that consider the barriers to optimal use of real-world evidence (RWE) in health technology assessment (HTA) and how to overcome them. The work was carried out as part of EUreccA 2025, in particular with the RWE workstream embodied within that collaboration. The starting premises of this workstream were that: 1) the acceptance of RWE by HTA agencies and payers in the assessment of drugs is sub-optimal and variable between jurisdictions; and 2) if that were not the case, the path of new pharmaceuticals to patients could be quicker and less expensive. In the first paper of this series, we set out the conclusions we had reached in the EUreccA RWE workstream. In this paper, we set out the methodology used to conduct the totality of the EUreccA 2025 RWE workstream effort, which led us to those conclusions. The main results, strengths and limitations of the individual parts are discussed further in separate papers in this supplement (Papers 3-5). Through scoping work, we generated four key topics within which to identify and address the barriers to optimal RWE use in HTA. Through pragmatic literature searches, stakeholder engagement and case studies, we suggest ways in which problems identified may be addressed, as a contribution to progress in this area.