Articlehybrid2018

Real-world evidence for coverage decisions: opportunities and challenges

Adrian Towse · William B Dreitlein · Chris Henshall · Steven D. Pearson

94 citations0/0 files storedJournal of Comparative Effectiveness Research

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Pharmaceutical Economics and Policy Healthcare Policy and Management Health Systems, Economic Evaluations, Quality of Life

Abstract

AIM: To explore current uses of real-world evidence (RWE) in the US healthcare system, summarize key concerns and highlight various opportunities that could be realized through best use of RWE. Materials & methods: Information was gathered via a literature review and interviews to generate a background paper for the 2017 Institute for Clinical and Economic Review Policy Summit meeting. RESULTS: RWE is currently being utilized in drug development decisions, regulatory approval decisions, post-approval monitoring, payer coverage decisions (initial decisions and reassessments) and for outcomes-based contracting. Solutions to key challenges and opportunities for future development are presented. CONCLUSION: Exciting opportunities for the use of RWE exist, yet important reservations remain. Solutions are within reach if effective partnerships between stakeholders can be nurtured.

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References

2007Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report 2010Reporting bias in medical research - a narrative review 2015Standards and guidelines for observational studies: quality is in the eye of the beholder

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