Real-world evidence for coverage decisions: opportunities and challenges. (9th November 2018)

• Record Type: Journal Article
• Authors: Hampson, Grace; Towse, Adrian; Dreitlein, William B; Henshall, Chris; Pearson, Steven D
• Is Part Of: Journal of comparative effectiveness research. Volume 7:Number 12(2018)
• Page Start: 1133
• Page End: 1143
• Publication Date: 2018-11-09
• Subjects: comparative effectiveness -- data generation -- evidence -- healthcare -- health technology assessment -- real-world data -- real-world evidence -- safety -- value; Medical care -- Research -- Periodicals; Medical care -- Research -- Evaluation -- Periodicals; Medical care -- Decision making -- Periodicals; Evidence-based medicine -- Periodicals; Medicine, Comparative -- Periodicals; 362.1072
• DOI: 10.2217/cer-2018-0066
• Languages: English
• ISSNs: 2042-6305

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.