R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27

Paul Arora; Sreeram V Ramagopalan

doi:10.57264/cer-2026-0144

July 14, 2026Journal of Comparative Effectiveness ResearchOpen Access

R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27

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Key Points

This update aims to outline the current progress and implications of real-world evidence in health technology assessment.
Review of the US FDA's updated compendium of real-world evidence in medical device regulatory decisions.
Analysis of real-world evidence in Canadian drug reimbursement submissions.
Examination of the Institute for Clinical and Economic Review's use of real-world evidence for US Medicare drug price negotiations.
US FDA updated guidelines reflect increased reliance on real-world evidence for medical device approvals.
Canadian drug reimbursement submissions increasingly incorporate real-world evidence, enhancing decision-making.
Real-world evidence plays a crucial role in Medicare drug price negotiations under the Inflation Reduction Act.

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Implication

Update reviews developments in real-world evidence influencing medical device and drug reimbursement decisions.

Abstract

In this update, we review the US FDA's updated compendium of real-world evidence (RWE) use in medical device regulatory decisions, a comprehensive scan of RWE utilization in Canadian drug reimbursement submissions, and Institute for Clinical and Economic Review's use of RWE to inform US Medicare drug price negotiations under the Inflation Reduction Act.

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Arora et al. (2026) studied this question.

synapsesocial.com/papers/6a5875842b46c88ba9ad149c https://doi.org/10.57264/cer-2026-0144

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R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27

Key Points

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Cite This Study

R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27

Key Points

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Implication

Abstract

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Cite This Study

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