International Journal of Technology Assessment in Health Care最新文献

A reflective analysis is presented on the potential added value that actuarial science can contribute to the field of health technology assessment. This topic is discussed based on the experience of several experts in health actuarial science and health economics. Different points are addressed, such as the role of actuarial science in health, actuarial judgment, data inputs and their quality, modeling methodologies and the use of decision-analytic models in the age of artificial intelligence, and the development of innovative pricing and payment models.

Objectives: Health technology assessment (HTA) guidelines are intended to support the successful implementation of HTA by enhancing consistency and transparency in concepts, methods, processes, and use, thereby enhancing the legitimacy of the decision-making process. This report lays out good practices and practical recommendations for developing or updating HTA guidelines to ensure successful implementation.

Methods: The task force was established in 2022 and comprised experts and academics from various geographical regions, each with substantial experience in developing HTA guidelines for national health policy making. Literature reviews and key informant interviews were conducted to inform these good practices. Stakeholder consultations, open peer reviews, and expert opinions validated the recommendations. A series of teleconferences among task force members was held to iteratively refine the report.

Results: The recommendations cover six key aspects throughout the guideline development cycle: (1) setting objectives, scope, and principles of the guideline, (2) building a team for a quality guideline, (3) defining a stakeholder engagement plan, (4) developing content and utilizing available resources, (5) putting in place appropriate institutional arrangements, and (6) monitoring and evaluating guideline success.

Conclusion: This report presents a set of resources and context-appropriate practices for developing or updating HTA guidelines. Across all contexts, the recommendations emphasize transparency, building trust among stakeholders, and fostering a culture of ongoing learning and improvement. The report recommends timing development and revision of guidelines according to the HTA landscape and pace of HTA institutionalization. Because HTA is increasingly used to inform different kinds of decision making in a variety of country contexts, it will be important to continue to monitor lessons learned to ensure the recommendations remain relevant and effective.

Background: There are wide variations in the practices of patient involvement in health technology assessment (HTA) in Europe. The field is lacking a consensus on good practices, leading to divergent processes, methods, and evaluation of patient involvement. To identify potential good practice approaches and current gaps, a structured online survey was conducted among HTA stakeholders, including HTA practitioners, patient stakeholders, industry representatives, and others who had experienced patient involvement in HTA.

Methods: The questionnaire was co-created by HTA experts, patient stakeholders, and industry representatives and disseminated between 29 April and 14 September 2022.

Results: Responses (n = 168) were submitted from thirty-two European countries by HTA practitioners (n = 33), patient stakeholders (n = 75), industry stakeholders (n = 42), providers (n = 5), academics (n = 7), and others (n = 6). The responses indicated that "allowing access to treatments that have demonstrated value"is the principle rationale for conducting HTA. In terms of the importance of patient involvement, there was consensus across stakeholder groups that "patients have insights and information [that] no other stakeholder has" and that patient involvement is important "to inform HTA which evidence is most patient-relevant". Shortcomings were identified in the lack of systematic and transparent processes, an unsatisfactory level of information and guidance, and minimal communication and collaboration.

Conclusions: The diverse stakeholders who responded highlighted the need for improving specific aspects of patient involvement practices, including better guidance and information, a more consistent flow of communication between the HTA body and participating patient stakeholders, and the need to develop and implement a consensus on good practices.

Introduction: Digital health technologies have been enhancing the capacity of healthcare providers and, thereby, the delivery of targeted health services. The Southeast Asia Region (SEAR) has invested in strengthening digital public health. Many digital health interventions have been implemented in public health settings but are rarely assessed using the holistic health technology assessment (HTA) approach.

Methods: A systematic literature review was performed to provide an overview of evaluations of digital public health interventions in the World Health Organization (WHO) SEAR. Searches were conducted on four electronic databases. Screening title abstracts and full texts was independently conducted by two reviewers, followed by data extraction. Dimensions of HTA were analyzed against the EUnetHTA Core Model 3.0. Quality assessment of included articles was conducted using the JBI Checklist for Economic Evaluation and Consolidated Health Economic Evaluation Reporting Standards 2022 checklist to assess the reporting quality. The findings are presented using systematic evidence tables and bar charts.

Results: Of the forty-three studies screened at the full-text stage, thirteen studies conducted across six countries were included in the analysis. Telemedicine and m-health interventions were assessed in ten studies. Nine studies conducted cost-effectiveness analysis, and five assessments were conducted from a societal perspective. Four studies utilized more than one perspective for the assessment. Health problem definition and current use of technology, description and technical characteristics of the technology, clinical effectiveness, costs, economic evaluation, and organizational aspects were assessed by all the studies, whereas legal aspects were least assessed.

Conclusion: The lack of HTAs on digital public health interventions in the region highlights the need for capacity-building efforts.

Objective: This paper reports on the process used to embark on one of the core strategies of Abu Dhabi's Department of Health, which was to develop a roadmap for HTA implementation and institutionalization, based on the aspirations and needs of local stakeholders and making use of the evidence-informed deliberative processes framework. The paper also highlights the main features of the road map that may be expected to address some of the current challenges.

Methods: A series of activities were undertaken that informed the subsequent development of the roadmap. They comprised a situation analysis using a combination of desk research and semistructured (group) interviews with 45 stakeholders. The findings were discussed in two workshops; face-to-face with nonindustry stakeholders from Abu Dhabi, and online with industry representatives.

Results: Guided by the EDP framework, the roadmap provides instructions how to organize stakeholder involvement, how to identify and operationalize decision criteria, and how to ensure that the decision-making process is transparent. Specific guidance is given on establishing an HTA structure with an appropriate policy framework, the formulation of an HTA program, a communication strategy, as well as building and leveraging HTA expertise.

Conclusion: Broad stakeholder consultation has been instrumental toward the establishment of a comprehensive HTA framework in Abu Dhabi, and the development of a road map. The interest raised during stakeholder consultations and the commitments made hold promise for the adoption and establishment of EDP principles to support HTA in Abu Dhabi that have potential to contribute to a sustainable high-quality healthcare system.

Caregivers can play an important role in supporting and caring for people with progressive, life-threatening, or debilitating conditions. However, this supportive role can expose caregivers to various detrimental financial, physical, and psychosocial issues. When evaluating medical technologies for reimbursement decisions, health technology assessment (HTA) agencies typically focus on the treatment's impact on patients and ignore or downplay the impact on caregivers. Including caregiver impacts within a wider societal perspective may better enable health systems to maximize health benefits from available resources. However, the lack of clear guidance or methodological recommendations from decision makers on the inclusion of caregiver impacts limits the number of HTA submissions that consider these effects. We outline a conceptual framework based on intensity and duration of caregiving to guide researchers, industry, and decision makers when developing policies for the inclusion of caregiver outcomes and justify their inclusion based on expected caregiver burden in identified circumstances.

Health Technology Assessment (HTA) in Europe has undergone significant evolution, culminating in the adoption of Regulation (EU) 2021/2282 on HTA (HTAR) aimed at fostering sustainable collaboration in HTA at the European Union (EU) level. The EUnetHTA 21 project, a 2-year initiative, was commissioned to address key methodological issues and prepare for the implementation of the HTAR. This commentary documents the outcomes of the EUnetHTA 21 project, focusing on Joint Clinical Assessments (JCAs), while analyzing challenges encountered and lessons learned for future collaboration under the HTAR. The EUnetHTA 21 consortium, comprising thirteen European HTA bodies, developed twenty guidance documents and thirteen templates, refining methods and procedures for joint work in HTA at EU level. Pilot JCAs and Joint Scientific Consultations were conducted to test these materials. Lessons learned from this experience emphasize the importance of inclusive consensus building, effective time and resource management, capacity building, and continuous quality improvement. The project's realization underscores a collective commitment among HTA bodies to continue to collaborate, now under a legal framework. Recommendations from the project, along with experiences gained from previous European Network for HTA (EUnetHTA) Joint Actions, provide a foundation for developing guidance for EU-HTA under the HTAR. Further proactive efforts at national and central levels are essential to coordinate and ensure a sustainable cooperation. The EUnetHTA 21 experience provides valuable insights for advancing cooperation in HTA under the HTAR, aiming to improve the quality of HTA, avoid duplication, and ultimately enhance patient access to safe and effective health technologies in the EU.

Background: Constrained resources under universal health coverage (UHC) necessitate a balance between medication costs and essential health system requirements. Policymakers practice priority-setting, as either implicit or explicit rationing, embedded in evidence-informed decision-making processes to guide funding decisions. Health technology assessment (HTA) is a method that may assist explicit evidence-informed priority setting. South Africa developed an official HTA methods guide in 2022, however before this, commissioning and performing economic evaluations was not standardized.

Methods: We conducted a descriptive collective case study to explore the impact of economic analyses on the selection of, and access to, essential medicines in South Africa. Four cases were purposefully selected, and both official information and secondary data, including media reports, were reviewed. Data elements were extracted and organized in a matrix. Cases were reported narratively with a positivist epistemological approach, presenting the authors' reflections.

Results: We found economic analyses that reflected methodologies described in the HTA guide: international reference pricing, cost-minimization, cost-effectiveness, cost-utility, and budget impact analyses. Economic analyses informing the 'resource-use' domain in the GRADE evidence-to-decision framework supported decision-making, influenced market-shaping with price reductions of interventions through benchmarking (fosfomycin, flucytosine), improved equitable access nationally (flucytosine), and prioritized a defined patient group in a justifiable and transparent manner (bortezomib).

Conclusion: A standardized HTA evaluation process guided by a nationally accepted framework is necessary for evidence-informed decision-making. Economic analyses (cost-effectiveness, affordability, and resource use) should be consistently included when making decisions on new interventions.

Health technology assessment (HTA) agencies assess evidence to support decision making about which technologies to provide and pay for in the health system. HTA impact is understood as the influence that HTA report findings can have in the health system, including impacts on reimbursement decisions, changes to health outcomes, or broader system or societal impacts. The International Network of Agencies for Health Technology Assessment (INAHTA) is a global network of publicly funded HTA agencies. INAHTA's mission, in part, is to advance the impact of HTA to support reimbursement decisions and the optimal use of health system resources. Each year, INAHTA awards the David Hailey Award for Best Impact Story to the member agency that shares the best story, as voted by fellow members, about HTA impact. The impact story sharing program in INAHTA contributes to a deeper understanding of what works well (or not so well) in achieving HTA impact. This paper provides six impact stories from agencies that were finalists for the 2021 and 2022 David Hailey Impact Award for Best Impact Story: the Institut national d'excellence en santé et en services sociaux, the Malaysian Health Technology Assessment Section, Ontario Health, the Center for Drug Evaluation, the National Institute for Health and Care Excellence, and Health Technology Wales. These stories demonstrate that HTA agencies can, in differing ways, effectively support governments in their efforts to place evidence at the centre of decision making.