Core value dossiers for medical technologies
Essential tool to support market access and marketing efforts through the lifecycle of the product
White Paper: Market access for medical devices in Europe: England, France, Germany, Italy and Spain
Get insights from MTRC White Papers to advance your understanding of European market access for medical devices
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Publication Digest: Requirements for patient-reported outcomes and data analytics in health technology assessment in England, France and Germany, and the need for methods harmonization across European markets: a qualitative interview study
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 publication, DiModica et al. explored the role of patient-reported outcomes (PRO) in HTA decision-making across England, France, and Germany. Through 12 expert interviews supported by a targeted literature review, the authors showed that PRO guidance differs substantially between countries, creating uncertainty for evidence generation and submission planning.
The study found a stronger perceived influence of PRO data in Germany and a more context-dependent impact in England and France. The authors also highlighted misalignment between national HTA expectations and emerging Joint Clinical Assessment guidance as an additional barrier to harmonized evidence use across Europe.
Access the full-text article here.