International practices in health technology assessment and public financing of digital health technologies: recommendations for Hungary.

Background: Evaluating and integrating digital health technologies is a critical component of a national healthcare ecosystem in the 2020s and is expected to even increase in significance. Design: The paper gives an overview of international practices on public financing and health technology assessment of digital health technologies (DHTs) in five European Union (EU) countries and outlines recommendations for country-level action that relevant stakeholders can consider in order to support uptake of digital health solutions in Hungary. A scoping review was carried out to identify and gather country-specific classifications and international practices on the financing DHTs in five pioneering EU countries: Germany, France, Belgium, the United Kingdom and Finland. Results: Several frameworks have been developed for DHTs, however there is no single, unified framework or method for classification, evaluation, and financing of digital health technologies in European context. European countries apply different taxonomy, use different assessment domains and regulations for the reimbursement of DHTs. The Working Group of the Hungarian Health Economic Society recommends eight specific points for stakeholders, importantly taking active role in shaping common clinical evidence standards and technical quality criteria across in order for common standards to be developed in the European Union single market. Conclusion: Specificities of national healthcare contexts must be taken into account in decisions to allocate public funds to certain therapies rather than others.

Outcome-based reimbursement in Central-Eastern Europe and Middle-East.

Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower income countries rely mainly on financial based agreements to manage uncertainties associated with new therapies. We performed a survey, an exploratory literature review and an iterative brainstorming in parallel about potential barriers and solutions to outcome-based agreements in Central and Eastern Europe (CEE) and in the Middle East (ME). A draft list of recommendations deriving from these steps was validated in a follow-up workshop with payer experts from these regions. 20 different barriers were identified in five groups, including transaction costs and administrative burden, measurement issues, information technology and data infrastructure, governance, and perverse policy outcomes. Though implementing outcome-based reimbursement models is challenging, especially in lower income countries, those challenges can be mitigated by conducting pilot agreements and preparing for predictable barriers. Our guidance paper provides an initial step in this process. The generalizability of our recommendations can be improved by monitoring experiences from pilot reimbursement models in CEE and ME countries and continuing the multistakeholder dialogue at national levels.

Delayed payment schemes in Central-Eastern Europe and Middle-East.

The need for innovative payment models for health technologies with high upfront costs has emerged due to affordability concerns across the world. Early technology adopter countries have been experimenting with delayed payment schemes. Our objective included listing potential barriers for implementing delayed payment models and recommendations on how to address these barriers in lower income countries of Central and Eastern Europe (CEE) and the Middle East (ME). We conducted a survey, an exploratory literature review and an iterative brainstorming about potential barriers and solutions to implement delayed payment models in these two regions. A draft list of recommendations was validated in a virtual workshop with payer experts from the two regions. Eight barriers were identified in 4 areas, including transaction costs and administrative burden, payment schedule, information technology and data infrastructure, and governance. Fifteen practical recommendations were prepared to address these barriers, including recommendations that are specific to lower income countries, and recommendations that can be applied more universally, but are more crucial in countries with severe budget constraints. Conclusions of this policy research can be considered as an initial step in a multistakeholder dialogue about implementing delayed payment schemes in CEE and ME countries.