Report

Impact of RWE on HTA Decision-making

Impact of RWE on HTA Decision-making

Pages 30 Pages

This report examines how real-world evidence (RWE) is increasingly used by health technology assessment (HTA) bodies to inform reimbursement and access decisions. It analyzes how different European HTA agencies evaluate RWE alongside clinical trial data, highlighting variation in acceptance, methodology expectations, and use cases. RWE is most often applied to address uncertainty around effectiveness, long-term outcomes, and real-world utilization. However, challenges remain related to data quality, transparency, and standardization. The report emphasizes the need for early planning, clear research questions, and fit-for-purpose data sources. It concludes that stronger alignment between regulators, HTA bodies, and manufacturers will be critical to maximizing the value of RWE in decision-ma

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