RWE in Europe - An Analysis

• Autorzy: Jennifer L Gill , Panos G Kanavos
• Języki publikacji: EN

Abstrakty

EN

Background - This paper outlines findings from four roundtable discussions involving a number of stakeholders. They aimed to improve understanding of the use of real world evidence (RWE) across Europe. They focused on the development of a three-year roadmap for the increased incorporation of RWE, increasingly recognized as a valuable source of information for market access and reimbursement, in decision-making. Methods - The meetings involved participants from 12 European countries. Participants had significant knowledge of specialist disease areas and commissioning of care and prior experience in the field of RWE. All four meetings involved plenary sessions with opportunity for discussion and feedback from participants. Specific topics of interest included the role of RWE in licensing, commissioning, clinical and patients and outcomes in chronic disease, oncology and rare diseases. Results - We garnered significant insight into the current and future use of RWE across Europe, developing a three-year roadmap of initiatives for the enhanced use of RWE in decision-making. Four initiatives were seen to be the most important at this stage: actively engaging in early dialogue with payers on RWE needs; a consensus exercise on RWD/RWE in clinical decisions; developing a definition of Patient Reported and Patient Relevant Outcomes (PRO); and developing a model approach for the collection of PRO. Conclusions - The roundtable discussions generated a wealth of information around the current and future value of RWE across Europe. Significant work is required in the areas of data generation, interpretation and use to make its inclusion in commissioning and licensing based decision-making more mainstream. (original abstract)

Słowa kluczowe

EN

Market; Patient rights protection; Health

PL

Rynek; Ochrona praw pacjenta; Zdrowie

• Czasopismo: Journal of Health Policy and Outcomes Research
• Rocznik: 2017
• Numer: nr 2
• Strony: 4--9

Twórcy

autor

Jennifer L Gill

• London School of Economics and Political Science, London

autor

Panos G Kanavos

• London School of Economics and Political Science, London

Bibliografia

• Makady A, Stegenga H, Ciaglia A, Debray TPA, Lees M, Happich M, Ryll B, Abrams K, Thwaites R, Garner S, Jonsson P, Goettsch W on behalf of GetReal Work Packages 1 & 4 (2017). Practical Implications of Using Real-World Evidence (RWE) in Comparative Effectiveness Research: Learnings from IMI-GetReal. Journal of Comparative Effectiveness Research doi.org/10.2217/cer-2017-0044
• Pietri G. & Masoura P. (2014) Market Access and Reimbursement: The Increasing Role of Real-World Evidence. Value in Health 17, A450-A1.
• Griffiths E.A. & Vadlamudi N.K. (2016) Not ready for the real world? The role of non-RCT evidence in health technology assessment. Value in Health 19, A286.
• Neville S. (2017) GSK 'real world' study offers new model for drug trials. In: Financial Times, London

Identyfikatory

DOI

10.7365/JHPOR.2018.1.1