Gill, Jennifer, Kanavos, Panos 
ORCID: 0000-0001-9518-3089, Albanell, Joan, Dank, Magdolna, Duncombe, Robert, Fink-Wagner, Antje, Hutton, John, Jahnz-Różyk, Karina, Kossler, Ingrid, Podrazilova, Katerina, Schramm, Wolfgang, Spandonaro, Federico, Thomas, Michael and Wartenberg, Markus
(2017)
RWE in Europe Paper II: The use of Real World Evidence in the disease context.
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London School of Economics and Political Science, London, UK.
Abstract
Real World Evidence (RWE), the use of data not collected via traditional randomised controlled trials (RCT) for decision-making, is becoming more interesting to market-access and reimbursement decision-makers, despite potential methodological issues around its use. This paper, the second in a series looking at the use of Real World Evidence (RWE) in Europe, analyses the opinions of a number of key experts in pricing and reimbursement from a selection of countries across Europe. Discussion centred on the use of RWE in licensing, commissioning, clinical decision-making and patient and outcome related decision-making in the context of three different treatment areas – chronic disease, oncology and rare diseases. Results of discussion sessions with ‘RWE experts’ indicated that the associated benefits of RWE are becoming more relevant but there is a need for a well-organised, high quality system for data generation, interpretation and use. It is likely that different treatment areas will have differing RWE requirements and differing levels of utility. In the rare disease arena, RWE may have a role in licensing based decisions, but this is unlikely for chronic disease or oncology. In order to enhance the role of RWE, and to ensure it meets its full potential in all treatment areas, a multi-stakeholder approach at the EU level is required, with collaboration between national and supranational organisations and all stakeholders including patient organisations, manufacturers and reimbursement agencies.
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