The Challenge of Sustainable Access to Telemonitoring Tools for People with Diabetes in Europe: Lessons from COVID-19 and Beyond.

Telemedicine in diabetes care has been evolving over several years, particularly since the advent of cloud-connected technologies for diabetes management, such as glucose monitoring devices, including continuous glucose monitoring (CGM) systems, that facilitate sharing of glucose data between people with diabetes and their healthcare professionals in near-real time. Extreme social distancing and shielding in place for vulnerable patients during the COVID-19 pandemic has created both the challenge and the opportunity to provide care at a distance on a large scale. Available evidence suggests that glucose control has in fact improved during this period for people with diabetes who are able to use CGM devices for remote glucose monitoring. The development of telemedicine as part of the standard of care in diabetes faces significant challenges in the European context, particularly in terms of providing consistent and effective care at a distance to large populations of patients while using robust systems that can be supported by large regional and national healthcare services. These challenges include a fragmented approach to healthcare technology assessment and reimbursement, lack of eHealth education and literacy, particularly amongst healthcare professionals, lack of data integration, as well as concerns about electronic health records, patient consent and privacy. Here we review the benefits of and challenges to wider application of telemedicine and telemonitoring in the post-pandemic future, with the aim to ensure that the value of these eHealth services is provided to patients, healthcare providers and health systems.

The transferability of health technology assessment: the European perspective with focus on central and Eastern European countries.

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 judgments of well-established HTA agencies of Western countries. AREAS COVERED: Based on considerations of transferability, the European Network for Health Technology Assessment (EUnetHTA) was built up to harmonize HTA methodologies across the European Union, and to develop an HTA Core Model by focusing on joint production of relative effectiveness assessment, which can be used as a basis for national value assessments. The second approach has been suggested in various forms without considering transferability issues. EXPERT OPINION: Joint clinical assessments reduce duplication of efforts based on appropriate scientific rationale. On the other hand, recent examples show that relying on judgments of HTA agencies from wealthier countries with potentially different health-care priorities can lead to suboptimal allocation decisions. In the short term, some stakeholders may benefit from ignoring transferability, but it will ultimately lead to limited access in other disease areas.

Implementation of Health Technology Assessment in the Middle East and North Africa: Comparison Between the Current and Preferred Status.

INTRODUCTION: Implementation of health technology assessment (HTA) is still in an early stage with some heterogeneity in the Middle East and North Africa (MENA). Our objective was to assess the current and future status of HTA implementation in the MENA region by focusing on regional commonalities. METHODS: Preparatory discussions for the first ISPOR conference in the MENA region indicated some potentially generalizable trends of HTA roadmaps. To widen the perspective, a policy survey was conducted among conference participants by applying an HTA implementation scorecard. Discussion group members helped to validate key conclusions during and after the conference. RESULTS: Health policy experts in MENA countries would like to facilitate HTA implementation and expect significant changes with some generalizable directions in 10 years compared to the current status according. HTA capacity building has to be strengthened by more graduate and postgraduate programs. Increased public budget and enhanced institutionalization are necessary success factors of HTA implementation. The scope of HTA has to be extended from pharmaceuticals to non-pharmaceutical technologies and to revision of previous policy decisions. Although cost-effectiveness with explicit threshold remains the most preferred HTA criterion, several other criteria have to be considered, maybe even by applying an explicit MCDA framework. The role of local evidence and data has to be strengthened in MENA countries, which translates to the extended use of local patient registries and payers' databases. Duplication of efforts can be reduced if international collaboration is integrated into national HTA implementation. DISCUSSION: Our results should be viewed as an initial step in a multi-stakeholder dialogue on HTA implementation. Each MENA country should develop its context-specific HTA roadmap, as such roadmaps are not transferable without taking into account country size, economic status, public health priorities and adopted systems of health care financing.

How Changes in Reimbursement Practices Influence the Financial Sustainability of Medicine Policy: Lessons Learned from Slovakia.

Objectives: The aim of this study was to review the impact of new reimbursement requirements for medicines in the Slovak Republic based on legislation that came into force in January 2018. Methods: The new legislation was reviewed. The reimbursement dossiers for medicines and health technology assessments and appraisals, justifications for reimbursement decisions, final reimbursement decisions, and all aspects of the appeal mechanisms have been transparently published on the website of the Slovak Ministry of Health and were used for this analysis. Results: Based on the new legislation, there was no need to submit information about relative effectiveness and cost-effectiveness of medicines with less than 1:50,000 eligible patients prior to reimbursement decisions, and the cost-effectiveness threshold has been increased for all other medicines. The estimated impact of the 2-year budget for the 59 medicines submitted for reimbursement without relative effectiveness and cost-effectiveness analysis was €181,273,698, based on the published submission dossiers. The estimated impact of the 2-year budget for the 45 medicines with evidence of relative effectiveness and cost-effectiveness was €178,566,634. In contrast to the easier market access criteria for new original medicines, the new legislation enforces stricter price erosion criteria for generic and biosimilar medicines. Consequently, the number of generic and biosimilar entries was reduced from 242 in 2017 to 224 in 2018. Conclusions: Although some of the new reimbursement applications were not approved by the Ministry of Health, many new medicines were added to the Slovak pharmaceutical reimbursement list based on "balanced assessment" requirements; hence, the system became financially unsustainable. It was necessary to change the legislation from January 2019.

Identifying the Need for Good Practices in Health Technology Assessment: Summary of the ISPOR HTA Council Working Group Report on Good Practices in HTA.

The systematic use of evidence to inform healthcare decisions, particularly health technology assessment (HTA), has gained increased recognition. HTA has become a standard policy tool for informing decision makers who must manage the entry and use of pharmaceuticals, medical devices, and other technologies (including complex interventions) within health systems, for example, through reimbursement and pricing. Despite increasing attention to HTA activities, there has been no attempt to comprehensively synthesize good practices or emerging good practices to support population-based decision-making in recent years. After the identification of some good practices through the release of the ISPOR Guidelines Index in 2013, the ISPOR HTA Council identified a need to more thoroughly review existing guidance. The purpose of this effort was to create a basis for capacity building, education, and improved consistency in approaches to HTA-informed decision-making. Our findings suggest that although many good practices have been developed in areas of assessment and some other key aspects of defining HTA processes, there are also many areas where good practices are lacking. This includes good practices in defining the organizational aspects of HTA, the use of deliberative processes, and measuring the impact of HTA. The extent to which these good practices are used and applied by HTA bodies is beyond the scope of this report, but may be of interest to future researchers.

Value-Based Pricing in Latin America: How Far Away Are We?

In February and September of 2017, the International Society for Pharmacoeconomics and Outcomes Research Health Technology Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.

IS THE EUNETHTA HTA CORE MODEL® FIT FOR PURPOSE? EVALUATION FROM AN INDUSTRY PERSPECTIVE.

OBJECTIVES: The HTA Core Model® was developed to improve the transferability of health technology assessment (HTA) between settings. The model has been used by HTA agencies but is also of interest to manufacturers, for improving internal evidence generation and communicating with other HTA stakeholders. To establish if the model is fit for purpose from an industry perspective, the pharmaceutical company Roche, collaborating with the European Network for HTA (EUnetHTA), conducted an assessment of the model. METHODS: A questionnaire was developed to evaluate all assessment elements in the HTA Core Model v2.0 for their usefulness in meeting payers' evidence needs and demonstrating value. The questionnaire was completed by country affiliate teams working in evidence generation and reimbursement submissions for pharmaceuticals. Survey results were discussed in workshops to ensure consistency and alignment between teams. RESULTS: The questionnaire was completed by six teams. An additional team from global pricing and market access participated in workshops. Model domains pertaining to the health problem and current technology use, technology description, clinical effectiveness, and economic value were considered most important because they meet payers' evidence needs. Overall, the model was considered useful to improve the efficiency of HTA evidence generation, share evidence internally, and communicate value to payers and HTA agencies. CONCLUSIONS: From an industry perspective, the HTA Core Model provides a useful framework and common terminology for efficient generation of transferable HTA evidence. The timeliness, efficiency, and transparency of HTA processes could be improved by a more standardized approach to HTA across settings.

The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

BACKGROUND AND OBJECTIVES: The HTA Core Model® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. METHODS: It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. RESULTS: The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. CONCLUSION: The HTA Core Model is now available for everyone around the world as a framework for assessing value.

European collaboration on relative effectiveness assessments: What is needed to be successful?

OBJECTIVE: The objective of this study is to identify the possible barriers and critical success factors for the implementation of European collaboration in the field of relative effectiveness assessment (REA) of drugs. METHODS: Data were gathered through semi-structured interviews with representatives from eight European health technology assessment (HTA) organisations involved in assessment of drugs for coverage decision-making (AAZ, AIFA, AHTAPol, HAS, HVB, IQWIG, NICE and ZiN). RESULTS: Potential barriers identified mainly relate to methodology, resources and challenges with implementation in the respective national processes (e.g. legal restrictions). The most critical success factors for production of cross-border assessments were the continuous cooperation of competent partners, and the quality and timely availability of the assessment. CONCLUSION: Further adaptation of the process and methods is required for optimal collaboration. In the near future it can be expected that cross-border assessments will meet in particular the needs of smaller/middle-sized European countries and also European countries with less developed HTA systems as the potential efficiency/quality gains are the highest for these countries. Therefore, national implementation of cross-border assessments is especially likely in these countries in the coming years. Once more experience is gained with cross-border assessments, and successes become more evident, efficiency/quality gains may also be likely for some larger countries with well established processes.

Improving the contribution of regulatory assessment reports to health technology assessments--a collaboration between the European Medicines Agency and the European network for Health Technology Assessment.

In response to a recommendation from the Pharmaceutical Forum, the European Medicines Agency and the European network for Health Technology Assessment initiated a collaboration with the aim to improve the contribution regulatory assessment reports can make to the assessment of relative effectiveness of medicinal products by health technology assessment bodies. This collaboration on improving European Public Assessment Reports (EPARs) started in February 2010 and was performed over 2 years. As a result, the templates for preparing EPARs were revised to better address the needs of heath technology organizations. The better understanding of information needs was a key outcome of the collaboration. To ascertain whether these template changes led to the inclusion of relevant information, a review of a small set of EPARs for recently approved medicinal products was carried out in parallel by both the European network for Health Technology Assessment and the European Medicines Agency. This report provides an account of this project on improving EPARs, which is part of the ongoing dialogue between regulators and health technology assessment bodies on a European level to support policymaker decisions in the future.

Health technology assessment: research trends and future priorities in Europe.

OBJECTIVE: To provide an overview of health services research related to health technology assessment (HTA) and to identify research priorities from a European perspective. METHODS: Several methods were used: systematic review of articles indexed with the MeSH term 'technology assessment' in PubMed from February 1999-2009; online survey among experts; and conference workshop discussions. RESULTS: Research activity in HTA varies considerably across Europe. The research was categorised into six areas: (1) the breadth of analysis in HTA (such as economic, organizational and social aspects); (2) HTA products developed to meet the needs of policy-makers (such as horizon scanning, mini-HTA, and core HTA); (3) handling life-cycle perspectives in relation to technologies; (4) topics that challenge existing methods and for which HTA should be developed to address the themes more comprehensively (such as public health interventions and organizational interventions); (5) development of HTA capacity and programmes; and (6) links between policy and HTA. An online survey showed that the three areas that were given priority were the relationship between HTA and policy-making (71%), the impact of HTA (62%) and incorporating patient aspects in HTA (50%). Policy-makers highlighted HTA and innovation processes as their main research priority (42%). Areas that the systematic review identified as future priorities include issues within the six existing research areas such as disinvestment, developing evidence for new technologies, assessing the wider effects of technology use, and determining how HTA affects decision-making. In addition, relative effectiveness and individualized treatments are areas of growing interest. CONCLUSIONS: The research priorities identified are important for obtaining high quality and cost-effective health care in Europe. Managing the introduction, use and phasing out of technologies challenges health services throughout Europe, and these processes need to be improved to successfully manage future more general challenges. An ageing population and a diminishing workforce both require strong efforts to ensure effective and well-organized use of human resources and technologies. Furthermore, Europe needs to focus on innovation. This is closely linked to use of technologies and calls for future research.

Exploring qualitative research synthesis: the role of patients' perspectives in health policy design and decision making.

Health systems are placing more and more emphasis on the design and delivery of services that are focused on the patient, and there is a growing interest in patient involvement in health policy research and health technology assessment (HTA). Furthermore, there is a growing research interest in eliciting patients' views, not only on 'what works' for patients but also on the need for intervention and on factors influencing the implementation of particular health technologies, their appropriateness and acceptability. This article focuses on qualitative research synthesis in eliciting patients' perspectives. Its aim is to bring research closer to policy development and decision making, to facilitate better use of research findings for health and welfare, to generate a body of evidence, and to ensure that effective and appropriate information is used in health policy decision design. A variety of synthesizing approaches in qualitative research are explored, such as meta-synthesis, meta-summary, meta-ethnography, and meta-study, focusing especially on methodology. Meta-synthesis and meta-ethnography are probably the most frequently cited approaches in qualitative research synthesis and have perhaps the most developed methodology. The implications of these various synthesizing approaches in relation to health policy and HTA are discussed, and we suggest that meta-synthesis and meta-summary are particularly useful approaches. They have an explicit focus on 'evidence synthesis', fairly clear methodologies, and they are designed to not only present interpretations of the findings but also integrate research findings. Qualitative research synthesis enables researchers to synthesize findings from multiple qualitative studies on patients' perspectives instead of establishing new, expensive, and perhaps redundant studies that might intrude on the lives of patients. Qualitative research synthesis is highly recommended by decision makers and in health policy research and HTA. In cases where patient assessment is important to overall success, it can provide those responsible for policy and decision making with a broad and varied range of knowledge about patients' perspectives before they make decisions on the application of health technologies.

Оценка медицинских технологий и формирование политики здравоохранения в странах Европы: Современное состояние, проблемы и перспективы

Постоянно предлагаются все новые технологические достижения, потенциально способствующие улучшению здоровья людей. Однако не все из них автоматически приводят к желаемому результату. Процедуры оценки технологий здравоохранения обеспечивают получение фактической информации о масштабах и характере использования конкретных вмешательств и методик, что позволяет оптимальным образом осуществить отбор наиболее эффективных, принимая в то же время во внимание весь комплекс сопутствующих организационных, социальных и этических факторов. В настоящей публикации проанализированы взаимоотношения между проводимой оценкой технологий здравоохранения и формированием политики и исследуется вопрос о том, как использовать результаты таких оценок для оптимизации процессов развития политики и принятия стратегических решений. Популяризируя как среди руководителей и организаторов здравоохранения, так и в более широкой аудитории, идеи ценности и потенциала методов оценки технологий здравоохранения, книга в конечном счете направлена на улучшение показателей здоровья населения за счет предоставления оптимальных медико-санитарных услуг.

Practical tools and methods for health technology assessment in Europe: structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA.

OBJECTIVES: This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations. METHODS: The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation. RESULTS: Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA. CONCLUSIONS: The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

The HTA core model: a novel method for producing and reporting health technology assessments.

OBJECTIVES: The aim of this study was to develop and test a generic framework to enable international collaboration for producing and sharing results of health technology assessments (HTAs). METHODS: Ten international teams constructed the HTA Core Model, dividing information contained in a comprehensive HTA into standardized pieces, the assessment elements. Each element contains a generic issue that is translated into practical research questions while performing an assessment. Elements were described in detail in element cards. Two pilot assessments, designated as Core HTAs were also produced. The Model and Core HTAs were both validated. Guidance on the use of the HTA Core Model was compiled into a Handbook. RESULTS: The HTA Core Model considers health technologies through nine domains. Two applications of the Model were developed, one for medical and surgical interventions and another for diagnostic technologies. Two Core HTAs were produced in parallel with developing the model, providing the first real-life testing of the Model and input for further development. The results of formal validation and public feedback were primarily positive. Development needs were also identified and considered. An online Handbook is available. CONCLUSIONS: The HTA Core Model is a novel approach to HTA. It enables effective international production and sharing of HTA results in a structured format. The face validity of the Model was confirmed during the project, but further testing and refining are needed to ensure optimal usefulness and user-friendliness. Core HTAs are intended to serve as a basis for local HTA reports. Core HTAs do not contain recommendations on technology use.

Involving stakeholders and developing a policy for stakeholder involvement in the European network for health technology assessment, EUnetHTA.

OBJECTIVES: This article explains how the issue of stakeholder involvement was addressed in the European network for Health Technology Assessment (EUnetHTA) Project and describes the structures of future stakeholder involvement in the EUnetHTA Collaboration. METHODS: Initiatives led to a dialogue with stakeholders and exchanging views and expectations on health technology assessment (HTA) processes and the future development of EUnetHTA. The methods of involving different stakeholder groups in EUnetHTA included general information to stakeholders about EUnetHTA, targeted information on a Web site, analysis of stakeholder opinions on HTA and EUnetHTA, and development of a draft stakeholder policy. RESULTS: First steps were taken to organize processes to consolidate the legitimacy of EUnetHTA and its products and encourage the representation of interests, thus contributing to promoting the utilization of HTA in national/regional policy making. A stakeholder Web site, analyses of stakeholder opinions on HTA and EUnetHTA in a discussion topic catalog, and a draft stakeholder policy resulted from the work. CONCLUSIONS: Stakeholder involvement in EUnetHTA is necessary to ensure the legitimacy and prospects for utilization of EUnetHTA and its products. The described activities and results create the foundation for a continued dialogue with, and involvement of, stakeholders. The EUnetHTA stakeholder meeting can be considered as a successful experience of dialogue between EUnetHTA and stakeholders, which should be continued. Our experience shows the challenge of obtaining balanced stakeholder representation across the identified stakeholder groups. Continued attention should be given to achieving balanced stakeholder representation.

European network for health technology assessment, EUnetHTA: planning, development, and implementation of a sustainable European network for health technology assessment.

OBJECTIVES: The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations. METHODS: Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders. RESULTS: EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration. CONCLUSIONS: The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

A history of health technology assessment at the European level.

This study summarizes the experience with health technology assessment (HTA) at the European level. Geographically, Europe includes approximately fifty countries with a total of approximately 730 million people. Politically, twenty-seven of these countries (500 million people) have come together in the European Union. The executive branch of the European Union is named the European Commission, which supports several activities, including research, all over Europe and in many other parts of the world. The European Commission has promoted HTA by several policy positions and has funded a series of projects aimed at strengthening HTA in Europe. Around fifteen of the European countries now have formal national programs on HTA and some also have regional public programs. All countries that are members of the European Union and do not have a national approach to HTA have an interest in becoming more involved. The HTA projects sponsored by the European Commission have focused on networking and collaboration among established agencies and institutions for HTA, however, also on capacity building, support, and facilitation in creating mechanisms for HTA in European countries that still do not have any program in the field.