Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

نویسندگان

چکیده

Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well potential health assessment (HTA) solutions to tackle them. This study aims provide guidance Central Eastern European (CEE) countries on how address key HTA MDs with special focus transferability scientific evidence. Methods: As part COMED Horizon 2020 project, a comprehensive list issues related MD were identified based targeted literature review. Health which pose greater challenge or require selected. Draught recommendations these developed discussed group. The then validated wider group experts, including reimbursement decision makers from CEE May June 2020. Results: A consolidated 11 3 major areas: (1) clinical value assessment, focusing use joint EU work, relying real-world evidence, coverage evidence development schemes, transferring foreign addressing learning curve centre effect; (2) economic covering cost calculation complex evaluations MDs; (3) processes, frequent product modifications various indications MDs. Conclusions: limited resources conducting HTA, can benefit methods generated countries. Considering appropriate reuse international materials, still implement even MDs, have more base compared pharmaceuticals.

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ژورنال

عنوان ژورنال: Frontiers in Public Health

سال: 2021

ISSN: ['2296-2565']

DOI: https://doi.org/10.3389/fpubh.2020.612410