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

Daubner-Bendes, Rita; Kovács, Sándor; Niewada, Maciej; Huic, Mirjana; Drummond, Michael; Ciani, Oriana; Blankart, Carl Rudolf; Mandrik, Olena; Torbica, Aleksandra; Yfantopoulos, John; Petrova, Guenka; Holownia-Voloskova, Malwina; Taylor, Rod S.; Al, Maiwenn; Piniazhko, Oresta; Lorenzovici, László; Tarricone, Rosanna; Zemplényi, Antal; Kaló, Zoltán (2021). Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges. Frontiers in Public Health, 8, p. 612410. Frontiers Research Foundation 10.3389/fpubh.2020.612410

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Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence.

Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020.

Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs.

Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Faculty Institutions > sitem Center for Translational Medicine and Biomedical Entrepreneurship > Healthcare Regulation and Management
11 Centers of Competence > KPM Center for Public Management

UniBE Contributor:

Blankart, Carl Rudolf Berchtold


300 Social sciences, sociology & anthropology > 350 Public administration & military science




Frontiers Research Foundation


[UNSPECIFIED] European Commission Horizon 2020


Projects 779306 not found.




Carl Rudolf Berchtold Blankart

Date Deposited:

03 Feb 2021 11:55

Last Modified:

17 Mar 2021 05:32

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