A framework to guide the optimal development and use of real-world evidence for drug coverage and formulary decisions

Author:

Pearson Steven D1,Dreitlein William B1,Towse Adrian2,Hampson Grace2,Henshall Chris2

Affiliation:

1. Institute for Clinical & Economic Review, Boston, MA, 02109, USA

2. Office of Health Economics, Southside, London, SW1E 6QT, UK

Abstract

Aim: To provide a framework for optimizing the development and use of real-world evidence (RWE) in drug coverage decisions. Materials & methods: The Institute for Clinical and Economic Review convened a Policy Summit with representatives from 23 payer and life science companies that compose the Institute for Clinical and Economic Review membership. Results: Summit participants helped refine a new conceptual framework that emphasizes the central role of contextual considerations and the evidentiary argument that the RWE is intended to support in designing the process for the development and interpretation of RWE. Conclusion: This framework may provide a structured way for pharmaceutical manufacturers and payers to develop a shared understanding of the best way to develop RWE that will ultimately be useful in informing coverage and formulary decisions.

Publisher

Future Medicine Ltd

Subject

Health Policy

Reference19 articles.

1. Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report

2. Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?

3. Massachusetts Institute of Technology. MIT NEWDIGS Hosts Design Lab on Efficacy to Effectiveness (E2E) data and decision-making. https://newdigs.mit.edu/news/mit-newdigs-hosts-design-lab-efficacy-effectiveness-e2e-data-and-decision-making.

4. Patient-Centered Outcomes Research Institute. The Aspirin Study. http://theaspirinstudy.org/.

5. Center for Medical Technology Policy. Real-World Evidence Initiative Report. www.cmtpnet.org/green-park-collaborative/published-recommendations/real-world-evidence.

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