Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
PICO in EU Joint Clinical Assessments for Medical Devices (Report 37)
Gain a comprehensive understanding of the PICO scoping process and its implications for medical device manufacturers
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EU HTA Publication Digest: Between Rigor and Relevance: Why the EU HTA Guidelines on Indirect Comparisons Miss the Mark
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest.
In a recent publication, Aballéa et al. critically reviewed the EU HTA Coordination Group guidelines on direct and indirect treatment comparisons in the context of joint clinical assessments. The authors found that the guidance imposes restrictive methodological positions and substantial operational requirements, while limiting the use of unanchored, population-adjusted, Bayesian, and non-randomized comparisons. These methods may be particularly important in rare or rapidly evolving indications. The authors concluded that a more flexible and empirically grounded framework is needed to support consistent assessments and timely access to innovative therapies.
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