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Real-world evidence for coverage decisions: opportunities and challenges
Grace Hampson1, Adrian Towse1, William B Dreitlein2
1Office of Health Economics, Southside, London, SW1E 6QT, UK.
Journal of Comparative Effectiveness Research
|November 10, 2018
Summary
Real-world evidence (RWE) is used in US healthcare for drug development, regulatory approvals, and payer decisions. Addressing concerns and fostering partnerships can unlock RWE
Area of Science:
- Health Services Research
- Pharmacoeconomics
- Clinical Informatics
Background:
- Real-world evidence (RWE) is increasingly integrated into the US healthcare system.
- Key stakeholders are exploring current applications and future potential of RWE.
Purpose of the Study:
- To examine the current utilization of RWE in the US healthcare landscape.
- To identify significant concerns and opportunities associated with RWE.
- To inform best practices for RWE implementation.
Main Methods:
- A comprehensive literature review was conducted.
- Interviews with key stakeholders were performed.
- Findings were synthesized into a background paper for a policy summit.
Main Results:
- RWE is actively employed in drug development and regulatory approval processes.
- Applications include post-approval monitoring, payer coverage decisions, and outcomes-based contracting.
- Key challenges and opportunities for RWE advancement were identified.
Conclusions:
- Significant opportunities exist for leveraging RWE in healthcare.
- Important reservations regarding RWE use require careful consideration.
- Effective stakeholder partnerships are crucial for realizing the full potential of RWE.
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