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 HTA solutions to tackle them. This study aims to provide guidance to Central and Eastern European countries on how to address methodological 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. HTA issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draft 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 : Overall, 31 experts representing 14 late technology adopter countries contributed to a consolidated list of 11 recommendations 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 : Late adopter CEE 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 to pharmaceuticals.