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Introduction A demand from the cardiac surgery and heart transplantation department of a French (Lyon) university hospital to adopt an ex‐vivo perfusion system of human donor hearts was a chance to actively involve patients in our hospital‐based health technology assessment (HB‐HTA) process. Material and Methods We selected an existing framework for patient involvement in HB‐HTA and involved patients at two stages of the HB‐HTA process: evaluation and dissemination. Firstly, we conducted a consultation‐oriented workshop to gather patient perspectives on the introduction of the technology in our hospital, based on their significant experience of healthcare. Secondly, we organized an information‐oriented workshop to communicate the HB‐HTA results to the patients consulted, after the decision had been taken. Results We modified the framework for patient involvement to suit the local decision‐making context, the HB‐HTA methodology, and the type of technologies assessed in our institution. Patients perceived the ex‐vivo perfusion system as a promising technology to facilitate access to heart transplantation. They emphasized the importance of a tailored information provided to patients about the potential use of the technology in their healthcare trajectories, and suggested involvement of patients to facilitate its implementation in hospitals. Discussion Modifying existing frameworks for patient involvement to fit specific local contexts should be encouraged, and has to address the need of timely information for decision‐makers and patient recruitment issues. Decision to incorporate patient perspectives and experiences should be made on a project‐by‐project basis, and focus on innovative medical devices with expected significant impact on patient quality of life. Effective and transparent communication and prospective feedbacks from HB‐HTA producers to patients are essential for a successful process. Patient or Public Contribution Three patients with a lived experience of heart transplantation, or another transplant procedure, or more broadly procedures involving innovative medical devices (specialists) and two patients recruited for societal issues and legitimacy of a collective voice were involved (generalists).

Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders.Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software.Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients’ ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations).Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.

Abstract This study analyzes the interactions between regulatory and health technology assessment (HTA) processes aimed at health systems coverage. A review was carried out in five databases to identify experiences of articulation between regulatory processes and HTA processes, and 19 publications were selected. Regarding the type of process, early dialogue, scientific advice and parallel advice stood out as forms of interaction between HTA and regulation. The studies addressed the interaction between HTA and health regulation for medicines coverage policies in health systems, with scant evidence in relation to other products. Furthermore, this interaction is basically described according to the entry of new technologies into health systems. The interaction between HTA and health regulation resulted in reduced deadlines for the commercialization and incorporation of the technology into health systems. The types of interaction processes identified can benefit the entire health system, increasing coverage and comprehensiveness of care. However, despite advances, some barriers to interaction between regulatory agencies and the management of coverage systems still persist. Resumo Este estudo analisa as interações entre os processos regulatórios e de avaliação de tecnologias de saúde (ATS) voltados para a cobertura dos sistemas de saúde. Foi realizada revisão em cinco bases de dados visando identificar experiências de articulação entre processos regulatórios e processos de ATS, sendo incluídas 19 publicações. Quanto ao tipo de processo, destacaram-se o early dialogue, scientific advice e parallel advice como forma de interação entre ATS e regulação. Os estudos abordaram a interação entre a ATS e a regulação sanitária para as políticas de cobertura de medicamentos em sistemas de saúde, sendo escassas as evidências em relação a outros produtos. Ademais, essa interação é descrita basicamente para o que se refere à entrada de novas tecnologias nos sistemas de saúde. A interação entre ATS e regulação sanitária resultou na redução de prazos para a comercialização e incorporação da tecnologia nos sistemas de saúde. Os tipos de processo de interação identificados podem apresentar benefícios para todo o sistema de saúde, aumentando a cobertura e a integralidade do cuidado, entretanto, apesar dos avanços, ainda persistem barreiras para a interação entre agências reguladoras e a gestão de sistemas de cobertura.

Background Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value. Objective To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment. Methods A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) 'Responsibilities and structure of HTA agencies'; (2) 'Evidence and evaluation criteria considered in HTAs'; (3) 'Methods and techniques applied in HTAs'; and (4) 'Outcomes and implementation of HTAs'. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts. Results All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional 'social value judgements' (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making. Conclusion More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness.

Health technology assessment (HTA) is a form of policy analysis that informs decisions about funding and scaling up health technologies to improve health outcomes. An equity-focused HTA recommendation explicitly addresses the impact of health technologies on individuals disadvantaged in society because of specific health needs or social conditions. However, more evidence is needed on the relationships between patient engagement processes and the development of equity-focused HTA recommendations. The objective of this study is to assess relationships between patient engagement processes and the development of equity-focused HTA recommendations. We analyzed sixty HTA reports published between 2013 and 2021 from two Canadian organizations: Canada's Drug Agency and Ontario Health. Quantitative analysis of the HTA reports showed that direct patient engagement (odds ratio (OR): 3.85; 95 percent confidence interval (CI): 2.40-6.20) and consensus in decision-making (OR: 2.27; 95 percent CI: 1.35-3.84) were more likely to be associated with the development of equity-focused HTA recommendations than indirect patient engagement (OR: .26; 95 percent CI: .16-.41) and voting (OR: .44; 95 percent CI: .26-.73). The results can inform the development of patient engagement strategies in HTA. These findings have implications for practice, research, and policy. They provide valuable insights into HTA.

Traditionally, health technology assessment (HTA) focuses on assessing the impact of pharmaceutical technologies on health and care. Resources are scarce and policy makers aim to achieve effective, accessible health care. eHealth innovations are increasingly more integrated in all healthcare domains. However, how eHealth is assessed prior to its implementation in care practices is unclear. To support evidence-informed policy making, this study aimed to identify frameworks and methods for assessing eHealth's impact on health care. The scientific literature in five bibliographical databases was systematically reviewed. Articles were included if the study was conducted in a clinical setting, used an HTA framework and assessed an eHealth service. A systematic qualitative narrative approach was applied for analysis and reporting. Twenty-one HTA frameworks were identified in twenty-three articles. All frameworks addressed outcomes related to the technical performance and functionalities of eHealth service under assessment. The majority also addressed costs (n = 19), clinical outcomes (n = 14), organizational (n = 15) and system level aspects (n = 13). Most frameworks can be classified as dimensional (n = 13), followed by staged (n = 3), hybrid (n = 3), and business modeling frameworks (n = 2). Six frameworks specified assessment outcomes and methods. HTA frameworks are available for a-priori impact assessment of eHealth services. The frameworks vary in assessment outcomes, methods, and specificity. Demonstrated applicability in practice is limited. Recommendations include standardization of: (i) reporting characteristics of eHealth services, and (ii) specifying assessment outcomes and methods following a stepped-approach tailored to the functional characteristics of eHealth services. Standardization might improve the quality and comparability of eHTA assessments.

Objective This study aims to systematically identify and summarize the key characteristics of Mini-Health Technology Assessment (Mini-HTA) and assess the completeness of its basic reporting information, providing a theoretical foundation for developing future reporting guidelines.. Methods A comprehensive search for Mini-HTAs was performed using CNKI, Wanfang Data, VIP, CBM, PubMed, Embase, Web of Science, HTA database, and major HTA-related websites from inception until February 2024. The completeness of basic information reporting in Mini-HTAs was assessed using the INAHTA checklist. The key characteristics of the included Mini-HTAs were summarized descriptively. Microsoft Excel 2019 was used to analyze and visually present the data. Results A total of 21 Mini-HTA reports were included, with the highest number published in 2021 (5 reports, 23.8 percent). China contributed the most reports (18 reports, 85.7 percent). The most common assessment purpose was technology comparison (15 reports, 71.4 percent), with general hospitals being the predominant assessment setting (17 reports, 80.9 percent), and drugs being the most frequently assessed technology type (14 reports, 66.7 percent). The INAHTA checklist evaluation identified notable deficiencies in reporting key methodological aspects, including participant roles, conflict of interest statements, data sources, literature search strategies, and methods for data assessment and analysis. Conclusion Mini-HTAs have significantly increased in China since 2020, mainly in technology comparison, drug evaluation, and general hospitals. However, gaps remain in reporting key aspects, such as participant roles, conflict of interest, and data sources. Future efforts should focus on refining reporting guidelines to improve consistency and address these reporting deficiencies in Mini-HTA.

Real-world evidence (RWE) can complement and fill knowledge gaps from randomized controlled trials to assist in health-technology assessment (HTA) for regulatory decision-making. However, the generation of RWE is an intricate process with many sequential decision points, and different methods and approaches may impact the quality and reliability of evidence. Standardization and transparency in reporting these decisions is imperative to appraise RWE and incorporate it into HTA decision-making. A partnership between Canadian health system stakeholders, namely, Health Canada and Canada’s Drug Agency (formerly the Canadian Agency for Drugs and Technologies in Health), was established to develop guidance for the standardization of reporting of RWE for regulatory and HTA decision-making in Canada. A collaborative initiative to create structured guidance for RWE reporting in the context of regulatory and HTA decision-making. The developed guidance aims to standardize and ensure transparent reporting of RWE to improve its reliability and usefulness in regulatory and HTA processes. This guidance can be adapted for other jurisdictions and will have future extensions to incorporate emerging issues with RWE and HTA decision-making.

To investigate stakeholder perspectives on how patient preference studies (PPS) should be designed and conducted to allow for inclusion of patient preferences in decision-making along the medical product life cycle (MPLC), and how patient preferences can be used in such decision-making. Two literature reviews and semi-structured interviews (n = 143) with healthcare stakeholders in Europe and the US were conducted; results of these informed the design of focus group guides. Eight focus groups were conducted with European patients, industry representatives and regulators, and with US regulators and European/Canadian health technology assessment (HTA) representatives. Focus groups were analyzed thematically using NVivo. Stakeholder perspectives on how PPS should be designed and conducted were as follows: 1) study design should be informed by the research questions and patient population; 2) preferred treatment attributes and levels, as well as trade-offs among attributes and levels should be investigated; 3) the patient sample and method should match the MPLC phase; 4) different stakeholders should collaborate; and 5) results from PPS should be shared with relevant stakeholders. The value of patient preferences in decision-making was found to increase with the level of patient preference sensitivity of decisions on medical products. Stakeholders mentioned that patient preferences are hardly used in current decision-making. Potential applications for patient preferences across industry, regulatory and HTA processes were identified. Four applications seemed most promising for systematic integration of patient preferences: 1) benefit-risk assessment by industry and regulators at the marketing-authorization phase; 2) assessment of major contribution to patient care by European regulators; 3) cost-effectiveness analysis; and 4) multi criteria decision analysis in HTA. The value of patient preferences for decision-making depends on the level of collaboration across stakeholders; the match between the research question, MPLC phase, sample, and preference method used in PPS; and the sensitivity of the decision regarding a medical product to patient preferences. Promising applications for patient preferences should be further explored with stakeholders to optimize their inclusion in decision-making.

Objectives The objective of this study is to evaluate the feasibility of implementing Hospital-Based Health Technology Assessment (HB-HTA) within Ukraine’s healthcare system, focusing on its potential to strengthen evidence-based decision-making regarding clinical effectiveness, safety, cost-efficiency, and organizational and strategic impact of health technologies (HTs) in healthcare facilities (HCFs). Methods We collected and synthesized key initiatives implemented between 2021 and 2025, outlining the main steps involved in introducing HB-HTA in Ukraine. Results The article describes the landscape of the Ukrainian healthcare system and shares the experience of the initial steps of HB-HTA introduction amid tight budgets and increasing demands. Drawing on international models and adapting them to the national context, we outline key implementation strategies, the development of scientific and methodological approaches for HB-HTA, and the integration of a pilot HB-HTA project within a leading national HCF known for its high-level diagnostic and operational capabilities. Conclusions The conducted pilot laid the groundwork for integrating HB-HTA into Ukraine’s healthcare system and demonstrated its role in empowering HCFs to guide smarter budget allocation and procurement decisions, especially in the context of decentralization. With continued investment in expertise, legal integration, and streamlined methodology, HB-HTA can become a cornerstone of transparent, cost-effective decision-making across the HCFs of the National healthcare system. The experience gained in Ukraine provides valuable insights that can support other countries in effectively adopting and utilizing HTs at the hospital level.