Background: Despite international initiatives on collaboration within the field of rare diseases, patient access to orphan medicinal products (OMPs) and healthcare services differ greatly between countries. This study aimed to create a comprehensive and in-depth overview of rare diseases policies and reimbursement of OMPs in a selection of 12 countries in the Western Eurasian region: Armenia,

Introduction: Lower income European countries have a worse health status and less funds for health care compared to Western Europe. Despite their limited human and financial capacities for conducting Health Technology Assessment (HTA), the need for evidence-based decision-making is growing. Two main approaches emerged as potential solutions: joint clinical assessments on the European level, and simplified procedures relying on the judgements of well-established HTA agencies of Western countries.

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.

Aim To develop pragmatic recommendations for Central and Eastern European (CEE) policymakers about transferability assessment of integrated care models established in higher income European Union (EU) countries. Methods Draft recommendations were developed based on Horizon 2020-funded SELFIE project deliverables related to 17 promising integrated care models for multimorbid patients throughout Europe, as well as on an online survey among CEE stakeholders on the relevance of implementation barriers. Draft recommendations were discussed at the SELFIE transferability workshop and finalized together with 22 experts from 12 CEE countries. Results Thirteen transferability recommendations are provided in three areas. Feasibility of local implementation covers the identification and prioritization of implementation barriers and proposals for potential solutions. Performance measurement of potentially transferable models focuses on the selection of models with proven benefits and assurance of performance monitoring. Transferability of financing methods for integrated care explores the relevance of financing methodologies and planning of adequate initial and long-term financing. Conclusions Implementation of international integrated care models cannot be recommended without evidence on its local feasibility or scientifically sound and locally relevant performance assessment in the country of origin. However, if the original financing method is not transferable to the target region, development of a locally relevant alternative financing method can be considered.

ObjectivesThe need for improving healthcare decision making by implementing health technology assessment (HTA) has been a top priority in Ukraine since 2016. This study sought to provide a tailor-made HTA implementation roadmap, drawing on insights from national stakeholders.MethodsWe conducted a survey using a questionnaire already applied in previous HTA research. We assessed the status of HTA when reforms were initiated in 2016 and examined perspectives on possible future developments among policy makers and representatives of pharmaceutical companies and patient organizations.ResultsThirty-two respondents answered the survey. Forty-eight percent of respondents were not aware of HTA training in Ukraine, but 91 percent preferred having either a graduate or postgraduate training. Experts stated that funding for HTA research and for critical appraisal of HTA submissions was limited, but in the future, they would increase funding mainly from public sources. A public HTA agency with academic support was the most preferred organizational structure. Eighty-eight percent of respondents opted for full transparency, making the HTA agency's recommendations and the related appraisal reports publicly available. A great majority of participants preferred mandating the use of local data in certain categories and indicated the importance of evaluating the transferability of international evidence. Healthcare priority and cost-effectiveness were the most important criteria for decisions, applied with a soft explicit threshold.ConclusionsUkraine is in the early phase of implementing HTA and our study provides a clear vision of national stakeholders about the future directions. In addition, learning from the experiences of other countries may help the implementation process.