Abstract

Acceptance of real-world evidence (RWE) is one key challenge in HTA. The upcoming European HTA will set new standards on the European level. Hence, recently published guidelines by EUnetHTA on RWE might have an impact on the national level. This study analyzes (1) the current problems in accepting RWE in (national) HTAs, (2) the methods are set out by EUnetHTA, and (3) the implications for upcoming national appraisals post 2025. German HTA will be analyzed here, as it can be considered one of the most rigorous national HTA within Europe.

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