International Journal of Technology Assessment in Health Care最新文献

Objectives: The EUnetHTA Core Model^® is well-established in the HTA community. Some recommendations of corresponding guidance documents leave room for alternative methodological choices. Considering the new HTA regulation (HTAR), we aimed to identify needs for concretization (NCs) in EUnetHTA guidance and provide indicative methodological options.

Methods: We carried out a qualitative document analysis and structured group discussion. Twenty-two EUnetHTA documents were screened using transparent criteria. Identified NCs were classified into topics according to the PRISMA statement and presented to Austrian HTA practitioners (n = 11) during a structured group discussion. Participants rated NC's importance. To identify potential solutions, selected key handbooks for generic (Cochrane) and HTA-specific (IQWIG/NICE) evidence synthesis were systematically reviewed and matching content was charted against the NCs.

Results: Thirty-two topics with varying numbers of NCs were identified, twenty-six during the screening process, and six from the group discussion. Most of the topics related to evidence synthesis methods (nine topics), evidence eligibility criteria (nine topics), risk of bias (three topics), and certainty assessment (three topics). Other topics related to information sources, search strategy, data collection process, data items, effect measures, and reporting bias. One or more methodological approaches and recommendations could be identified for each identified topic from the included methodological handbooks.

Conclusions: Our analysis identified a need for concretization in some EUnetHTA guidelines. The structured overview of methodological options may support HTA doers in adapting and applying the guidelines to the national and local practical context.

It is not often that international collaborations are sustained for any significant period, let alone for three decades. However, despite relying on largely voluntary contributions of individuals within its member institutions, the International Network of Agencies for Health Technology Assessment (INAHTA) has not only been an example of sustained collaboration over 30 years but also an example of how an initially modest collaboration can grow and thrive. Current and former serving Chairs and secretariat of the Network have come together to review network documents and outputs and reflect on the history of INAHTA, since its inception in Paris in 1993. Building on the paper from Hailey et al 2009 that documented the growth of the network after 15 years, we have considered and documented the factors that we believe have helped sustain the network and enable it to flourish in the subsequent 15 years. We have also considered the various challenges experienced along the way, as these too can aid in making a collaboration stronger. Future directions for the network have also been contemplated, given the evolving nature of HTA and the regional collaborations that have recently emerged. We hope that by sharing the lessons learned from this living example of international global collaboration relationships between like-minded organizations can be similarly fostered and enhanced into sustainable collaborations, for the benefit of all.

Background: Left ventricular assist devices (LVAD) are a therapeutic option in patients with advanced heart failure (HF) not a candidate for cardiac transplant as destination therapy (DT). However, important uncertainties remain regarding the use of LVAD in the long-term in real practice settings. When planning registries, it is important to choose the appropriate outcomes that ensure comparability and reduce the possibility of bias.

Aim: The purpose of this study was to establish a minimum dataset (MDS) that should be collected in all LVAD for DT registries to meet the needs and demands of Health Technology Assessment (HTA) doers and health professionals.

Methods: To design the MDS for LVAD, a preliminary list of outcome domains and data items were developed attending to the gaps and research needs derived from existing evidence coming from HTA carried out at the European Network of Health Technology Assessment (EUnetHTA) level. The list of data items and domains was agreed upon by all involved HTA organizations and a three-round Delphi was conducted among an experienced panel of cardiologists to rate the importance of the items for measuring uncertainty gaps.

Results: After the three-round Delphi process, the expert panel reached a consensus regarding eighteen outcomes and forty-seven variables divided into seven main domains (safety, effectiveness, patient acceptability, satisfaction, healthcare system impact, pharmaceutical management, and technique-related factors).

Conclusions: The MDS of outcomes and measures, developed based on research gaps and needs, can allow for standardizing data collection and improving the quality of data for decision making and practice.

Objectives: Advances in mobile apps, remote sensing, and big data have enabled remote monitoring of mental health conditions, but the cost-effectiveness is unknown. This study proposed a systematic framework integrating computational tools and decision-analytic modeling to assess cost-effectiveness and guide emerging monitoring technologies development.

Methods: Using a novel decision-analytic Markov-cohort model, we simulated chronic depression patients' disease progression over 2 years, allowing treatment modifications at follow-up visits. The cost-effectiveness, from a payer's viewpoint, of five monitoring strategies was evaluated for patients in low-, medium-, and high-risk groups: (i) remote monitoring technology scheduling follow-up visits upon detecting treatment change necessity; (ii) rule-based follow-up strategy assigning the next follow-up based on the patient's current health state; and (iii-v) fixed frequency follow-up at two-month, four-month, and six-month intervals. Health outcomes (effects) were measured in quality-adjusted life-years (QALYs).

Results: Base case results showed that remote monitoring technology is cost-effective in the three risk groups under a willingness-to-pay (WTP) threshold of U.S. GDP per capita in year 2023. Full scenario analyses showed that, compared to rule-based follow-up, remote technology is 74 percent, 67 percent, and 74 percent cost-effective in the high-risk, medium-risk, and low-risk groups, respectively, and it is cost-effective especially if the treatment is effective and if remote monitoring is highly sensitive and specific.

Conclusions: Remote monitoring for chronic depression proves cost-effective and potentially cost-saving in the majority of simulated scenarios. This framework can assess emerging remote monitoring technologies and identify requirements for the technologies to be cost-effective in psychiatric and chronic care delivery.

Objective: The aim of this study is to propose and validate a value assessment framework for Health Technology Assessment (HTA) for rare diseases drugs in Brazil.

Methods: A scoping review was performed to identify criteria used by HTA agencies in countries with public healthcare systems when evaluating orphan drugs. Based on the findings, a criteria framework for rare disease drugs was proposed for Brazil. Content validity was conducted over three rounds using Delphi technique and content validity ratio (CVR) approach was employed to evaluate the ratings from the eighteen stakeholders (experts and patients).

Results: Twenty-nine HTA criteria for rare disease drugs were identified to compose the Brazilian framework. After three Delphi rounds, the final value framework comprised fifteen criteria categorized into four domains: disease-related factors, treatment-related factors, social and political factors, and economic factors. Among the most well-rated criteria by the CVR, considering the relevance attribute, were "relevance of outcomes for a rare disease," "impact on patient's quality of life," "price negotiation," and "adjusted cost-effectiveness threshold." On the other hand, "budget impact threshold," "innovative nature of treatment," and "willingness to accept greater uncertainty in clinical evidence" received negative evaluations and were excluded from the final framework.

Conclusions: A value assessment framework validated by key stakeholders of rare diseases in Brazil could contribute to improve HTA transparency, decision making, and efficiency of the healthcare system, and inspire the development of a local guidance for rare-disease HTA.

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.