Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
White Paper: Challenges of HTA and Reimbursement Submissions for Medical Devices
Get insights from MTRC White Papers to explore the complexities of reimbursement and HTA submissions for medical devices in Europe and discover practical solutions to overcome these challenges
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Publication Digest: Evaluation of Health Technology Assessment Frameworks for In Vivo Diagnostics: Assessing Methodological Gaps and Implications for Market Access
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest.
In a recent study, De la Fuente et al. examined HTA guidance in 28 countries to understand methodological approaches to in vivo diagnostics for market access and reimbursement, focusing on molecular imaging tracers and contrast media. While in vitro diagnostics were consistently assessed as medical technologies across all countries, in vivo diagnostics were often reviewed under pharmaceutical models, with the diagnostic procedure evaluated separately. Analysis of case studies showed that such variations in methodology and evidence requirements can result in divergent reimbursement decisions, even when clinical data are comparable.
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