Our objective was to explore procedures and methods used at health technology assessment (HTA) agencies for assessing medical devices and the underlying views of HTA practitioners about appropriate methodology to identify challenges in adopting new methodologies for assessing devices. We focused on the role of normative commitments of HTA practitioners in the adoption of new methods.

An online survey, including questions on procedures, scoping, and assessments of medical devices, was sent to members of the International Network of Agencies for Health Technology Assessment. Interviews were conducted with survey respondents and HTA practitioners involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Survey and interview questions were inspired by the “values in doing assessments of health technologies” approach towards HTA, which states that HTA addresses value-laden questions and information.

The current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as commitments of HTA practitioners to principles of evidence-based medicine, make the adoption of a new methodology difficult.

There is a broad recognition that assessments of medical devices may need changes in HTA methodology. In order to realize this, the HTA community may require both a discussion on the role, responsibility, and goals of HTA, and resulting changes in institutional context to adopt new methodologies.

Since 2017, health technology assessment (HTA) has been included in the Ukrainian Health Law fundamentals and its implementation has accelerated since it became mandatory in 2020. SAFEMed has been supporting the Ministry of Health in integrating HTA into the decision-making ecosystem and building capacity in HTA. In this 2022 to 2023 project, we aimed to create and conduct HTA training for doers, users, and trainers based on a developed model curriculum for an HTA master’s program, and to identify sets of criteria for successful training and training centers.

First, we reviewed websites and documents of current academic HTA master’s and advanced programs worldwide. Second, we performed an assessment of the training needs of HTA doers, users, and trainers in Ukraine using an online survey that captured level of experience and knowledge gaps. Third, we reviewed the capacity and quality requirements of existing academic centers that provide HTA training.

We identified seven HTA master’s programs globally, which covered five HTA domains: (i) health problem and current use of the technology; (ii) description and technical characteristics; (iii) safety; (iv) clinical effectiveness; and (v) costs and economic evaluations. Other aspects of HTA, such as ethical, legal, social, and cultural aspects were also covered, but not in all programs. The needs assessment was completed by 40 doers (53%), users (43%), and potential trainers (5%) of HTA in Ukraine. Specific knowledge gaps included: comparative effectiveness, health economics, qualitative evidence synthesis, patient and public involvement, and ethical issues. The proposed program addresses these gaps and includes an introduction to HTA that is in line with the new HTA definition. We also generated a minimum set of quality assurance criteria to ensure successful training and to develop efficient training centers for delivering HTA programs.

Our study provides a strong foundation for planning and conducting sustainable HTA training for current and future doers, users, and trainers in Ukraine, which can be an example for other countries wishing to increase HTA capacity.

The mission of the Department of Health (DoH) of Abu Dhabi in the United Arab Emirates is to provide its population with a healthy life and world leading preventive and curative services. While the DoH has regulations in place to grant market approval to new health technologies, there is a need to develop a clear overall framework for reimbursement and disinvestment decisions. Establishing a structured health technology assessment (HTA) framework is critical for informing decisions on health technologies that offer value for money, with the aim of improving equitable access to health care, financial risk protection, and, ultimately, better health outcomes.

During 2022, the DoH collaborated with the Radboud University Medical Center to explore the feasibility of applying an evidence-informed deliberative process (EDP) HTA approach through workshops and interviews involving all stakeholders in the ecosystem, such as policy makers, principal investigators, providers, patients and public groups, product manufacturers, payers, and purchasers. A situational analysis was conducted to collect stakeholders’ views and build EDPs. Based on this analysis, a structured roadmap was developed.

The comprehensive five-year roadmap to implement a holistic HTA framework in Abu Dhabi consisted of five major elements, starting with the establishment of an appropriate HTA policy framework as a foundation. Abu Dhabi should firmly establish its HTA structure and program (in one to two years), and at the same time invest in developing and retaining HTA training capacity so that over time (within three to five years) the country can build up its own expertise to sustain the program. This needs to be accompanied by continuous awareness raising among all relevant stakeholders.

This roadmap is the first and most important step toward implementing a holistic HTA framework in Abu Dhabi. Technical work needs to be complemented by continuously raising awareness and involving all relevant stakeholders. Looking at the initial results and international benchmarks, HTA will significantly contribute to achieving a sustainable, high quality healthcare system.

Uncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface.

Six online discussions among WG members (Dec 2021–Sep 2022) who examined the output of a scoping review, two literature-based case studies and a survey; application of the initial guidance to a real-world case study; and two international conference panel discussions.

The WG identified key concepts, clustered into twelve building blocks that were collectively perceived to define uncertainty: “unavailable,” “inaccurate,” “conflicting,” “not understandable,” “random variation,” “information,” “prediction,” “impact,” “risk,” “relevance,” “context,” and “judgment.” These were converted into a checklist to explain and define whether any issue constitutes a decision-relevant uncertainty. A taxonomy of domains in which uncertainty may exist within the regulatory-HTA interface was developed to facilitate categorization. The real-world case study was used to demonstrate how the guidance may facilitate deliberation between stakeholders and where additional guidance development may be needed.

The systematic approach taken for the identification of uncertainties in this guidance has the potential to facilitate understanding of uncertainty and its management across different stakeholders involved in drug development and evaluation. This can improve consistency and transparency throughout decision processes. To further support uncertainty management, linkage to suitable mitigation strategies is necessary.

To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE.

Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results.

All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders’ definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines.

Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as “given”; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap.

The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review.

A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation.

The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.

There is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.

Based on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.

Expertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.

The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

Depending on the health system context and the demands of relevant stakeholders in countries, the need, organizational structure, and prerequisites for enabling capacity building and development in health technology assessment (HTA) will vary. Core competencies are instrumental in this and include essential knowledge, skills, and attitudes (KSAs). They provide building blocks for delivering high-quality and effective practices of HTA. We aimed to systematically explore and develop an overview of the core competencies necessary for HTA.

This study was conducted during 2016–19 using different methods in a structured manner. We drew concepts of KSAs from various literature sources, surveyed universities and HTA professionals, and conducted expert workshops to arrive at a common understanding of the required competencies.

The terminology for KSAs defining competencies in HTA programs has been clarified. In addition, a list of competencies offered through different educational and training programs has been created. The surveys provided clarity on a common understanding of KSAs among HTA stakeholders. Thereafter, a set of competencies was described and classified according to the HTA domains.

Our study shows that there is diversity in HTA programs offered by educational institutions. The content of the programs varies due to differences between countries regarding the level of HTA development and the need for HTA, including the understanding of what HTA is. The preparation of a competency checklist or a “menu” of options mirroring the diversity of HTA will ensure that the specific needs of the HTA community will be covered.

Evidence-informed deliberative processes (EDPs) were introduced to guide health technology assessment (HTA) agencies to improve their processes toward more legitimate decision making. A survey among members of the International Network of Agencies for HTA (INAHTA) showed that EDPs can also be relevant for countries that have not (yet) established such an agency. Therefore, we explored to what extent low- and middle-income countries (LMIC) applied the steps and elements stipulated in the EDP framework and their need for guidance.

The survey among INAHTA members was slightly adapted to address LMIC context and sent to 416 experts identified through several HTA sources. The questions focused on contextual factors and the EDP steps (installation of an appraisal committee, selecting technologies and criteria, assessment, appraisal, communication and appeal). Data collection took place between 21 May and 1 September 2019. Descriptive statistics and qualitative analyses were used to summarize the findings.

We received sixty-six meaningful responses from experts in thirty-two LMIC. We found that contextual factors to support HTA development are overall not present or only present to some extent. Respondents indicated that guidance was needed for specific elements related to selecting technologies and criteria, assessment, appraisal, as well as communication and appeal.

EDPs have the potential to provide steps for improving HTA processes. The results of this study can serve as a baseline measurement for future monitoring and evaluation of EDP application in the responding LMIC. This could support the countries in improving their processes and enhancing legitimate decision making when using HTA.

An international joint task group co-led by the International Network of Agencies for Health Technology Assessment (INAHTA) and Health Technology Assessment International (HTAi) has developed a new and internationally accepted definition of HTA.

The task group, consisting of representatives of leading HTA networks, societies and global organizations, developed guiding principles for the process and followed an established consultation plan with the broader HTA community to develop the definition.

The consensus achieved by the international joint task group brings the collective weight of the participating networks, societies, and organizations behind the new definition.

The new definition of HTA is an historic achievement and it is offered to the current and emerging HTA world as a cornerstone reference for today and into the future.

Health Technology Assessment (HTA) is where facts and values meet: the evidence that is considered relevant to the assessment of a technology depends on the value framework used. In the context of the European project VALIDATE (Values in doing assessments of healthcare technologies), we assessed to what extent this interplay between facts and values is acknowledged in HTA reports on non-invasive prenatal testing (NIPT). Our aim is to gain a better understanding of this fact-value relationship, and to contribute to the development of capacity for ethical analyses in HTA.

Five reviewers independently analyzed HTA reports on NIPT, obtained from the National Institute for Health Research (NIHR) HTA database, by answering a structured questionnaire on: (i) arguments, values, and conclusions; (ii) relations between values and collected evidence; (iii) operationalizations of the values involved. Ethical argumentation was analyzed using the method of specifying norms. This method holds that for general, abstract ethical principles to reach concrete cases, principles need to be specified in such a way as to achieve maximal coherence between different value commitments and practice. The results of the analysis were discussed in joint meetings to arrive at a consensus on interpretation.

Our results show that the pivotal role of values in defining what counts as relevant evidence and why, is rarely acknowledged. The same holds for the importance of specifying values as a means to achieve greater coherence between the use of healthcare technologies and a range of values.

There is ample room for improvement in clarifying the role of values in HTA: they can serve to explain and justify what evidence is considered relevant to the assessment of a healthcare technology. Recognizing that abstract values need specification in order to reach concrete cases opens up new opportunities for exploring in what way values are affected by healthcare technologies.

To analyze the current development of HTA in China and to identify areas for improvement, we mapped the level of HTA development in China and compared it with the level of HTA development in ten other countries using a survey instrument.

We launched a nationwide survey targeting different stakeholders. For this purpose, we used a validated instrument that enables mapping HTA development in a country using eight domains. The views of the respondents regarding the overall level of HTA development and for each domain were compared with the results of a mapping study that included ten countries.

In total, we received 222 responses, 33 from policy-makers, 158 from researchers, and 31 from industry, as well as health provider representatives including 8 from hospitals, centers for disease control and prevention. We calculated the mean score for the level of HTA development. The overall HTA development for China was scored at 76.4 (out of a maximum of 146). Although the total score for China was comparable to the mean score of 75.6 among the ten countries, China scored significantly lower than the mean score of 117.0 among the three developed countries. In addition, China scored significantly lower in the domain of institutionalization compared to the other ten countries.

China needs to tackle the issue of low HTA institutionalization to strengthen the foundation of HTA development. Future government initiatives that institutionalize HTA, for example, establishing a national HTA system or consortium, will improve the development of HTA in China.

To develop a definition of “capacity building” relevant to Health Technology Assessment international (HTAi).

A review of capacity building activities undertaken by HTAi members, members of the International Network of Agencies for Health Technology Assessment (INAHTA), and regional HTA networks was compared against general literature on capacity building definitions and frameworks. The findings were reviewed by the HTAi Scientific Development and Capacity Building Committee. Furthermore, the Executive Committee and Interest Groups of HTAi provided input on the draft final paper.

The literature demonstrated the need for a definition of capacity building specific to HTA. In the context of HTAi, it was necessary for the definition to cover (i) the broadest range of HTA-related activities, (ii) multiple stakeholders involved in the HTA process, and (iii) the spectrum of activities that compose capacity building. We propose the following definition of HTA capacity building: The process by which individuals and organizations develop or strengthen abilities related to understanding, providing input to, conducting, or utilizing HTA for health policy and decision making, as well as, developing awareness and support in the environment within which HTA is being used.

A definition of HTA-related capacity building that was intended to provide clarity about what this term means to HTAi was developed. As HTA is context-dependent, a need for further work to develop an operationalization “menu” relevant to the specific needs in which HTA is being used was identified.

Real-world evidence (RWE), derived from real-world data (RWD), is already used, to some extent, for health technology assessment (HTA) purposes. With the increased availability of RWD, there is potential for more widespread use but also challenges ensuring reliable RWE for HTA. Opportunities to overcome key challenges, identified at a scoping meeting, were discussed during the 2019 HTA international (HTAi) Global Policy Forum (GPF).

Reflection of discussions using Design Thinking (an interactive process aimed to solve complex problems) between seventy-three representatives from not-for-profit, for-profit organizations, and HTAi leadership. The discussions were informed by a background paper, and presentations from three invited keynote speakers and eleven GPF members.

Several options were listed for addressing the identified key challenges: quality and acceptability, governance and accountability, transferability, and informing decision making. The GPF emphasized that the HTA community should first understand what questions could be answered with RWE. Additionally, more clarity on methods, standards, streamlining RWD collection, data sharing across jurisdictions, replication of RWD, and expert analysis were mentioned as important priorities.

The HTA community is currently standing at a cross-road as it is not yet fully equipped to address these key challenges. It is, therefore, time for action. The community should start aligning on what is the best source of evidence according to purpose and how the data should be collected to create reliable evidence. It should also initiate the development of actions and guidance to properly develop and manage RWD/RWE to inform decision making across the technology lifecycle.