Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping

Abstract

Background The adoption of digital health care within health systems is determined by various factors, including pricing and reimbursement. The reimbursement landscape for digital health in Europe remains underresearched. Although various emergency reimbursement decisions were made during the COVID-19 pandemic to enable health care delivery through videoconferencing and asynchronous care (eg, digital apps), research so far has primarily focused on the policy innovations that facilitated this outside of Europe. Objective This study examines the digital health reimbursement strategies in 8 European countries (Belgium, France, Germany, Italy, the Netherlands, Poland, Sweden, and the United Kingdom) and Israel. Methods We mapped available digital health reimbursement strategies using a scoping review and policy mapping framework. We reviewed the literature on the MEDLINE, Embase, Global Health, and Web of Science databases. Supplementary records were identified through Google Scholar and country experts. Results Our search strategy yielded a total of 1559 records, of which 40 (2.57%) were ultimately included in this study. As of August 2023, digital health solutions are reimbursable to some extent in all studied countries except Poland, although the mechanism of reimbursement differs significantly across countries. At the time of writing, the pricing of digital health solutions was mostly determined through discussions between national or regional committees and the manufacturers of digital health solutions in the absence of value-based assessment mechanisms. Financing digital health solutions outside traditional reimbursement schemes was possible in all studied countries except Poland and typically occurs via health innovation or digital health–specific funding schemes. European countries have value-based pricing frameworks that range from nonexistent to embryonic. Conclusions Studied countries show divergent approaches to the reimbursement of digital health solutions. These differences may complicate the ability of patients to seek cross-country health care in another country, even if a digital health app is available in both countries. Furthermore, the fragmented environment will present challenges for developers of such solutions, as they look to expand their impact across countries and health systems. An increased emphasis on developing a clear conceptualization of digital health, as well as value-based pricing and reimbursement mechanisms, is needed for the sustainable integration of digital health. This study can therein serve as a basis for further, more detailed research as the field of digital health reimbursement evolves.

Tracing Digital Therapeutics Research Across Medical Specialties: Evidence from ClinicalTrials.gov

“…Recent analyses highlighting heterogeneity in trial design and timing underscore the importance of these efforts 11 . At present, the fragmented landscape of reimbursement and health technology assessment pathways for DTx poses significant challenges to both adoption and successful commercialization of DTx worldwide 34,35 . In the context of the US, the misalignment between the FDA's risk/benefit assessments and payer health economic evaluations can create barriers to both market access and viable reimbursement pathways for DTx products, as evidenced by the bankruptcy of Pear Therapeutics 31…”

“…11 At present, the fragmented landscape of reimbursement and health technology assessment pathways for DTx poses significant challenges to both adoption and successful commercialization of DTx worldwide. 34,35 In the context of the US, the misalignment between the FDA's risk/benefit assessments and payer health economic evaluations can create barriers to both market access and viable reimbursement pathways for DTx products, as evidenced by the bankruptcy of Pear Therapeutics. 31 DTx also offers a great opportunity to gather RWD and generate RWE in order to better understand patient outcomes and intervention effects.…”

Systematically mapping and analysing multi-level policy developments: a methodological toolkit

“…The systematic policy review methodology retains the core elements of a scoping review in the sense that it also involves the establishment of clear inclusion and exclusion criteria, the development of a comprehensive search strategy, and frequently a narrative synthesis [21][22][23][24][25][26][27][28][29][30][31][32]. However, in contrast to traditional scoping reviews, the databases searched are not academic databases but policy databases or repositories.…”

“…A cross-sectional analysis is most appropriate if policies from a short time-period have been mapped or if a policy eld is still emerging in which case longitudinal developments are scarce to non-existent. In a cross-sectional policy mapping article, raw policy data is presented per country in tabulated form (as shown above in Table 3), whereas crosscountry differences are described narratively [31]. For this type of analysis, it is good practice to use several preselected criteria to compare the mapped policies to.…”

“…For this type of analysis, it is good practice to use several preselected criteria to compare the mapped policies to. For instance, in a study on reimbursement processes for digital health, four distinct reimbursement characteristics were studied: (1) whether digital health solutions are recognized as a reimbursable form of health care, (2) what mechanisms are used to reimburse digital health solutions, (3) how digital health solutions are priced and whether value-based health care frameworks are embedded in that process, and (4) whether any funding is available to reimburse digital health solutions outside of public or private insurance policies [31].…”