Highlights
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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.
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Publication history
Publication stage
In Press Accepted ManuscriptFootnotes
Author contributions
Concept and design: Akehurst, Murphy, Solà-Morales, Cunningham, Mestre-Ferrandiz, de Pouvourville, Fricke
Acquisition of data: Murphy, de Pouvourville, Mantovani, Lindgren
Analysis and interpretation of data: Akehurst, Murphy, Solà-Morales, Cunningham, Mestre-Ferrandiz, de Pouvourville, Mantovani, Lindgren
Drafting of the manuscript: Akehurst, Murphy, Solà-Morales, Cunningham, Mestre-Ferrandiz, de Pouvourville, Fricke
Critical revision of the paper for important intellectual content: Akehurst, Murphy, Solà-Morales, Cunningham, Mestre-Ferrandiz, de Pouvourville, Mantovani, Fricke, Lindgren
Statistical analysis:
Provision of study materials or patients: Mantovani, Lindgren
Obtaining funding: Akehurst, Murphy, Solà-Morales, Cunningham, Mestre-Ferrandiz, de Pouvourville
Administrative, technical, or logistic support:
Supervision:
Other:
Conflict of Interest Disclosure statement:
Dr Akehurst and Dr Murphy are employees of Lumanity, which received funding from Novartis AG for the work submitted. Lumanity also received funding from Novartis AG outside the submitted work. Dr Solà-Morales reported receiving institutional fees from Novartis AG for the work submitted. He has also reported received institutional fees from Novartis AG outside the submitted work. Dr Cunningham, Dr de Pouvourville, Dr Fricke, and Dr Mestre-Ferrandiz reported receiving personal fees from Novartis AG for the work submitted. Dr Cunningham, Dr Fricke and Dr de Pouvourville reported received personal fees from Novartis AG outside the submitted work. Dr Lindgren reports receiving grants from Novartis AG for the work submitted; and grants from AstraZeneca, MSD, EFPIA and IPHA outside the submitted work. Dr Mantovani reports personal fees from Novartis during the conduct of the study. He also reported receiving grants and personal fees from Biogen, Novartis, Almirall; Roche; Bayer, and personal fees from Pfizer, outside the submitted work. The authors declare no patents or copyrights. No other disclosures were reported.
Support/Funding: Novartis
Acknowledgements
The RWE Steering group: Jorge Mestre-Ferrandiz, Silvia Meije, Sorcha Corry, Ron Akehurst, Oriol Solal-Moralès, Mary Harney, Luka Voncina
Lumanity support group: Ann-Marie Chapman, Linda Murphy, Jake Horgan.
