Discover the top HTA agencies embracing real-world evidence (Canada, Australia, England) for regulatory decisions and improved healthcare outcomes.
Question
Select the most open health technology assessment agencies to using Real world evidence
A. Canada
B. Germany
C. Australia
D. England
E. France
Answer
A. Canada
C. Australia
D. England
Explanation
The health technology assessment (HTA) agencies most open to using real-world evidence (RWE) are Canada (A), Australia (C), and England (D). Below is a detailed analysis of their RWE integration efforts:
Canada
Canada’s Drug Agency (CDA-AMC) has partnered with Health Canada and other stakeholders to advance RWE adoption, including developing Guidance for Reporting Real-World Evidence to standardize RWE use in regulatory and HTA decisions.
The agency co-chairs a national RWE Steering Committee and emphasizes RWE’s role in addressing evidence gaps for rare diseases and smaller populations.
Australia
Australia’s 2024 HTA Policy and Methods Review prioritized RWE as a key reform, proposing 50 recommendations to enhance RWD infrastructure, cross-jurisdictional data sharing, and standardized analytics.
The review highlights RWE’s importance in resolving uncertainties in managed entry agreements and improving decision-making transparency.
England
The UK’s National Institute for Health and Care Excellence (NICE) expanded its criteria to include RWE from electronic health records and registries alongside clinical trial data.
The MHRA’s 2025 RWE Scientific Dialogue Programme facilitates collaboration between regulators and innovators to refine RWE methodologies for HTA and regulatory evaluations.
Why Not Germany or France?
Germany relies on registries for RWE, but limited high-quality national registries and inconsistent data collection practices hinder broader adoption.
France uses RWE in post-registration studies (PRS) to address uncertainties, but reliance on accelerated clinical trials reduces the robustness of pre-approval evidence.
Canada, Australia, and England lead in institutionalizing RWE through governance frameworks, infrastructure investments, and collaborative initiatives. Germany and France lag due to fragmented data ecosystems and methodological challenges.
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