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

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.

Mapping Factors That Affect the Uptake of Digital Therapeutics Within Health Systems: Scoping Review.

BACKGROUND: Digital therapeutics are patient-facing digital health interventions that can significantly alter the health care landscape. Despite digital therapeutics being used to successfully treat a range of conditions, their uptake in health systems remains limited. Understanding the full spectrum of uptake factors is essential to identify ways in which policy makers and providers can facilitate the adoption of effective digital therapeutics within a health system, as well as the steps developers can take to assist in the deployment of products. OBJECTIVE: In this review, we aimed to map the most frequently discussed factors that determine the integration of digital therapeutics into health systems and practical use of digital therapeutics by patients and professionals. METHODS: A scoping review was conducted in MEDLINE, Web of Science, Cochrane Database of Systematic Reviews, and Google Scholar. Relevant data were extracted and synthesized using a thematic analysis. RESULTS: We identified 35,541 academic and 221 gray literature reports, with 244 (0.69%) included in the review, covering 35 countries. Overall, 85 factors that can impact the uptake of digital therapeutics were extracted and pooled into 5 categories: policy and system, patient characteristics, properties of digital therapeutics, characteristics of health professionals, and outcomes. The need for a regulatory framework for digital therapeutics was the most stated factor at the policy level. Demographic characteristics formed the most iterated patient-related factor, whereas digital literacy was considered the most important factor for health professionals. Among the properties of digital therapeutics, their interoperability across the broader health system was most emphasized. Finally, the ability to expand access to health care was the most frequently stated outcome measure. CONCLUSIONS: The map of factors developed in this review offers a multistakeholder approach to recognizing the uptake factors of digital therapeutics in the health care pathway and provides an analytical tool for policy makers to assess their health system's readiness for digital therapeutics.

A Conceptual Framework for Evaluating National Organ Donation and Transplantation Programs.

Conceptual frameworks are valuable resources that can be used to guide the planning, evaluation, and development of healthcare services. However, there are currently no comprehensive frameworks focused on organ donation and transplantation that identify the critical factors underlying a successful national program. To address this knowledge gap, we developed a conceptual framework that takes into account all major domains of influence, including political and societal aspects as well as clinical implementation. The framework was initially constructed based on a targeted review of the relevant medical literature. Feedback provided by a panel of international experts was incorporated into the framework via an iterative process. The final framework features 16 essential domains that are critical for initiating and maintaining a successful program and improving the health of patients with organ failure. Of particular note, these domains are subject to three overarching health system principles: responsiveness, efficiency, and equity. This framework represents a first attempt to develop a whole-system view of the various factors that contribute to the success of a national program. These findings provide a useful tool that can be adapted to any jurisdiction and used to plan, evaluate, and improve organ donation and transplantation programs.

Ten Lessons From the Spanish Model of Organ Donation and Transplantation.

The organ donation and transplantation program in Spain has long been considered the gold standard worldwide. An in-depth understanding of the Spanish program may promote the development and reform of transplant programs in other countries. Here, we present a narrative literature review of the Spanish organ donation and transplantation program supplemented by expert feedback and presented according to a conceptual framework of best practices in the field. Core features of the Spanish program include its three-tiered governing structure, close and collaborative relationships with the media, dedicated professional roles, a comprehensive reimbursement strategy, and intensive tailored training programs for all personnel. Several more sophisticated measures have also been implemented, including those focused on advanced donation after circulatory death (DCD) and expanded criteria for organ donation. The overall program is driven by a culture of research, innovation, and continuous commitment and complemented by successful strategies in prevention of end-stage liver and renal disease. Countries seeking ways to reform their current transplant systems might adopt core features and may ultimately aspire to include the aforementioned sophisticated measures. Countries intent on reforming their transplant system should also introduce programs that support living donation, an area of the Spanish program with potential for further improvement.

Lessons From the Portuguese Solid Organ Donation and Transplantation System: Achieving Success Despite Challenging Conditions.

Over the past two decades, Portugal has become one of the world leaders in organ donation and transplantation despite significant financial constraints. This study highlights how Portugal achieved success in organ donation and transplantation and discusses how this information might be used by other countries that are seeking to reform their national programs. To accomplish this goal, we performed a narrative review of relevant academic and grey literature and revised our results after consultation with two national experts. Our findings were then synthesized according to a conceptual framework for organ donation and transplantation programs. Our results revealed several key strategies used by the Portuguese organ donation and transplantation program, including collaboration with Spain and other European nations, a focus on tertiary prevention, and sustained financial commitment. This report also explores how cooperative efforts were facilitated by geographical, governmental, and cultural proximity to Spain, a world leader in organ donation and transplantation. In conclusion, our review of the Portuguese experience provides insight into the development of organ donation and transplantation systems. However, other countries seeking to reform their national transplant systems will need to adapt these policies and practices to align with their unique cultures and contexts.

Solid Organ Donation and Transplantation in the United Kingdom: Good Governance is Key to Success.

The United Kingdom (UK) supports a highly successful organ donation and transplantation program. While the UK originally had one of the lowest organ donation rates in Europe, sustained reforms have resulted in steady improvement. Of note, the UK nearly doubled its rate of deceased donations between 2008 and 2018. In this report, we present a case study of the UK organ donation and transplantation program as an example of a complete system with sound and inclusive governing structures that are strongly integrated with critical programs focused on training and research. This study was based on an initial targeted review of the literature led by a UK expert that included guidelines, national reports, and academic papers. Feedback solicited from other European experts was incorporated into our findings via an iterative process. Overall, the study highlights the stepwise evolution of the UK program that ultimately became successful largely due to ongoing collaborative efforts carried out at all levels. Centralized coordination of all aspects of the program remains a key driver of improved rates of organ donation and transplantation. The designation and empowerment of expert clinical leadership have helped to maintain focus and promote ongoing quality improvement.

The National Organ Donation and Transplantation Program in Greece: Gap Analysis and Recommendations for Change.

Greece has fallen far behind many comparable European countries in the field of organ donation and transplantation and has made little progress over the past decade. Despite efforts to improve its organ donation and transplantation program, systemic problems persist. In 2019, the Onassis Foundation commissioned a report to be prepared by the London School of Economics and Political Science that focused on the state of the Greek organ donation and transplantation program and proposed recommendations for its improvement. In this paper, we present our analysis of the Greek organ donation and transplantation program together with an overview of our specific recommendations. The analysis of the Greek program was undertaken in an iterative manner using a conceptual framework of best practices developed specifically for this project. Our findings were further developed via an iterative process with information provided by key Greek stakeholders and comparisons with case studies that featured successful donation and transplantation programs in Croatia, Italy, Portugal, Spain, and the United Kingdom. Because of their overall complexity, we used a systems-level approach to generate comprehensive and far-reaching recommendations to address the difficulties currently experienced by the Greek organ donation and transplantation program.

Organ Donation in Croatia: The Importance of a National Champion, a Comprehensive Plan, and International Collaborations.

The Republic of Croatia is a global leader in organ donation and transplantation despite having fewer resources and more modest healthcare expenditures than other countries in the European Union. The results of an extensive literature review were combined with expert input in an iterative multi-step data collection and evaluation process designed to assess trends in Croatian organ donation and transplantation and identify key elements, policy changes, and drivers of the system that have contributed to its success. Multiple sources of evidence were used in this study, including primary documents, national and international transplantation reports, and insights from critical informants and content experts. The results highlight several key organizational reforms that have substantially improved the performance of the Croatian transplant program. Our findings emphasize the importance of strong central governance led by an empowered national clinical leader acting under the direct auspices of the Ministry of Health and a comprehensive and progressive national plan. The Croatian transplant system is notable for its integrated approach and efficient manner of managing scarce health resources. Collectively, the results suggest that Croatia has become nearly self-sufficient due to its systematic implementation of the guiding principles for organ donation and transplantation.

How to Structure a Successful Organ Donation and Transplantation System in Eight (Not So Easy) Steps: An Italian Case Study.

Valuable information can be obtained from a systematic evaluation of a successful national transplant program. This paper provides an overview of Italy's solid organ transplantation program which is coordinated by the National Transplant Network (Rete Nazionale Trapianti) and The National Transplant Center (Centro Nazionale Trapianti). The analysis is based on a system-level conceptual framework and identifies components of the Italian system that have contributed to improving rates of organ donation and transplantation. A narrative literature review was conducted and the findings were validated iteratively with input from subject matter experts. The results were organized into eight critical steps, including 1) generating legal definitions of living and deceased donation, 2) taking steps to ensure that altruistic donation and transplantation become part of the national culture and a point of pride, 3) seeking out existing examples of successful programs, 4) creating a situation in which it is easy to become a donor, 5) learning from mistakes, 6) working to diminish risk factors that lead to the need for organ donation, 7) increasing the rate of donations and transplantations via innovative strategies and policies, and 8) planning for a system that supports growth.

The future of oncology policy.

To ensure the previous progress seen in cancer survival rates continues as we move through the 21st Century it is important to determine future effective policy related to oncology healthcare delivery and funding. Recent successes with, for example, the COVID vaccine response, the decision-making agility exhibited by governments and healthcare systems and the effective use of telehealth and real-world evidence highlight the progress that can be made with pooled efforts and innovative thinking. This shared approach is the basis for the European Beating Cancer Plan which outlines action points for governments and health systems for the period 2021-2025. It focuses on a whole government approach, centred on patients, maximising the potential of new technologies and insights across policy areas including employment, education, transport and taxation, enabling the tackling of cancer drivers in schools, workplaces, research labs, towns and cities and rural communities. Despite the plan there are still concerns that oncology policy has not adequately responded to the pace of innovation and the unique challenges generated by innovative oncological technologies. There needs to be focus on: gaining consensus on the most appropriate methods to assess and price combination therapies and cell and gene therapies, developing effective outcome-based payment models for personalised medicine and developing consensus on the ideal approach for multiple indication pricing. Finally, future policy needs to ensure pharmaceutical companies and other research organisations are adequately rewarded for innovation to ensure continued R&D and the development of innovative oncological products.