Across-Country Variations of Real-World Data and Evidence for Drugs: A 5-European-Country Study

Published:January 25, 2023DOI:
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      • Using a combination of desk research and expert opinion collated by country experts in England, France, Germany, Italy, and Sweden, this paper aims to provide the reader with an understanding of the use of real-world evidence for HTA and reimbursement decisions in each geography. The paper also helps identify key issues shared across the countries and identify areas of improvement that might reduce scepticism and promote more efficient use of real-world evidence.



      To describe the role of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) in five European countries; to identify the hurdles to the acceptance of RWE and suggest directions towards its more effective use.


      Authors from France, Germany, Italy and Sweden used a common template to extract evidence. For England, the Cancer Drugs Fund (CDF) was described and analysed as a particular model for the use of RWD to provide evidence for coverage decisions and managed entry agreements.


      In all countries except Germany, HTA bodies acknowledged the relevance of RWD/RWE to address post-launch uncertainties. In Germany, evidence from randomized controlled trials remains the gold standard, and evidence based on RWD is generally rejected. Multiple sources of RWD exist, but the quality, the immediate relevance of existing sources, and their interoperability limit their adaptation to the specifics of a given drug. This leads to scepticism about the validity of the evidence. Timing is also a key issue: the production of evidence may not be synchronized with the HTA and pricing bodies’ agendas. The CDF case emphasizes that a strong partnership between all stakeholders and a pragmatic use of existing data, alongside clinical evidence provided by companies, are key success factors.


      A continuous investment in national health information systems is a key issue for providing valid RWE. Processes and aids to guide the acceptability and usage of RWE derived from pairing between sources and questions are essential.


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