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

Autori
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

Izvornik
Frontiers in Public Health (2296-2565) 8 (2021); 612410, 10

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Central-Eastern Europe (CEE) ; health technology assessement (HTA) ; medical device (MD) ; methodological challenge ; real world evidence (RWE) ; transferability ; value assessment.

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Javno zdravstvo i zdravstvena zaštita

Napomena
The European Union's Horizon 2020 research and
innovation programme _ Grant Agreement #779306
(COMED—Pushing the Boundaries of Cost and Outcome
Analysis of Medical Technologies)

POVEZANOST RADA