Randomised controlled trials (RCT), traditionally seen as the gold standard in drug approval requirement terms, are becoming more difficult to conduct due to, among other reasons, budget constraints, increasing complexities and the shrinking of patient populations.
Real world evidence (RWE), data used for decision making that is not derived from traditional RCT, may in future play an increasing role in market access and reimbursement decisions.
Using the Medical Technology Research Group’s expertise and extensive network, this project developed a series of Ad Boards to capture insight on the use of RWE in a number of European countries from key experts, including representatives from academia, health services, government bodies, payers and patient associations.
Paper I: The Use of Real World Evidence in the European Context
Authors: Jennifer Gill, Bernard Avouac, Robert Duncombe, John Hutton, Karina Jahnz-Różyk, Wolfgang Schramm, Federico Spandonaro, Michael Thomas & Panos Kanavos
This paper analyses key pricing and reimbursement stakeholders’ opinions of RWE across five European countries via a focus group-style discussion. Areas probed included regulatory implications and the role of RWE in the study countries, RWE processes and implementation on decision making, meaningful outcomes from RWE and priorities for future focus and industry support.
Paper II: The Use of Real World Evidence in the Disease Context
Authors: Jennifer Gill, Joan Albanell, Magdolna Dank, Robert Duncombe, Antje Fink-Wagner, John Hutton, Karina Jahnz-Różyk, Ingrid Kossler, Katerina Podrazilova, Wolfgang Schramm, Federico Spandonaro, Michael Thomas, António Vaz Carneiro, Markus Wartenberg & Panos Kanavos
This paper 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.
Paper III: A Roadmap for RWE
Authors: Jennifer Gill, Joan Albanell, Bernard Avouac, Karin Berger, Finn Boerlum Kristensen, Heiner Bucher, Robert Duncombe, Antje Fink-Wagner, John Hutton, Karina Jahnz-Różyk, Ingrid Kossler, Katerina Podrazilova, Federico Spandonaro, Michael Thomas, António Vaz Carneiro, Markus Wartenberg & Panos Kanavos
This paper outlines the discussions held between key opinion leaders in pricing and reimbursement across a number of European countries at a roundtable-style meeting.
Paper IV: Engaging Pharma in the RWE Roadmap
Authors: Jennifer Gill, Daniela d’Angela, Karin Berger, Magdolna Dank, Robert Duncombe, Antje Fink-Wagner, John Hutton, Ingrid Kossler, Katerina Podrazilova, Michael Thomas & Panos Kanavos
This report describes discussions at the most recent meeting held in October 2017 in Zurich where the objectives were to gain insights into new approaches in RWE; share experiences and expertise in RWE initiatives; and define the way forward for the group.
Paper V: Policy Challenges around Real World Evidence Adoption in Europe
Authors: Bregtje Kamphuis, Bernard Avouac, Ramon Colomer, Antje Fink-Wagner, Holger Gothe, John Hutton, Martina Jänicke, Katerina Podrazilova, Federico Spandonaro, Jaroslav Štěrba, António Vaz Carneiro & Panos Kanavos
This fifth paper outlines the perceived challenges for the adoption of RWE in Europe, the potential role for the pharmaceutical industry to support the adoption of RWE, and how RWE can provide key data in HTA decision-making where other sources are less feasible.
Journal of Health Policy & Outcomes Research - RWE in Europe: An Analysis
24 March 2018