Real-world evidence (RWE) is essential to support decision-making by health technology assessment (HTA) bodies and payers, especially for highly innovative medicines. Yet, realizing the full value of RWE requires alignment among all stakeholders involved in its generation and use.
This publication, developed by the multi-stakeholder initiative RWE4Decisions, presents updated actions for HTA bodies, payers, industry, clinicians, patients, and data analytical experts across the EU and Canada to strengthen the role of RWE in health technology assessment. Drawing on focus groups with stakeholders, the paper offers clear, actionable guidance to reduce fragmentation, improve data use, and build trust in the role of RWE.
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