搜索结果：International journal of technology assessment in health care

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.. 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. 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. 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.

Despite omics technologies gaining traction in clinical settings, particularly in oncology, challenges persist in their widespread adoption due to the pre-requisite robust evidence supporting efficacy and cost-effectiveness. This study aims to explore the experiences of organizations working in the health technology assessment (HTA) field in evaluating omics technologies, with a particular focus on the adoption and application of specific assessment frameworks. We conducted a global survey to gather insights into current practices and frameworks used in HTA evaluations of omics technologies. We gathered responses from thirty-nine participants representing organizations across twenty-nine countries and five continents. Among them, 51 percent (n = 20) reported experience in evaluating omics technologies, including multi-omics tests for early disease detection, biomarker-based cancer diagnostics, and advanced genomic sequencing techniques. Only three organizations employed specific assessment frameworks: the Adelaide Health Technology Assessment Agency in Australia, the Netherlands Cancer Institute, and the Andalusian HTA Agency in Spain. These frameworks address key evaluation aspects such as analytical and clinical validity, clinical and personal utility, organizational impact, and ethical, legal, and social implications of omics technologies. Despite their relevance, the limited adoption of tailored frameworks highlights the need for more structured and context-specific approaches to facilitate the integration of omics technologies into healthcare systems. Collaborative efforts among stakeholders, including patients, healthcare providers, policymakers, and industry representatives, are crucial for devising robust evaluation strategies addressing the complexities of omics technologies comprehensively.

Since the introduction of health technology assessment (HTA) in Ukraine, the international technical assistance project "Safe, Affordable, and Effective Medicines for Ukrainians" with financial contributions of the United States Agency for International Development has supported capacity building activities. In 2020, the main HTA stakeholders expressed interest in a comprehensive training program for HTA doers, users, and trainers. To inform the design of a training program, the needs of forty HTA doers, users, and potential trainers were assessed using validated surveys. Identified knowledge gaps included comparative effectiveness, health economics, qualitative evidence synthesis, patient and public involvement, and ethical issues. Based on these results a tailored training program consisting of five modules was developed, including an introduction to HTA, as well as a train-the-trainers program. During January-July 2023, seventy-five persons participated in the training program, while twelve HTA professionals followed the train-the-trainer program. We evaluated participants' self-reported knowledge and skill gains by asking about their confidence level in each learning objective at the beginning and end of each training module. For each module, a learning effect was observed among participants. Furthermore, the majority of trainers felt confident to provide the introductory module on HTA, while for the other modules only one or two trainers felt completely confident to teach the content. Establishing a training program based on the needs of HTA doers, users, and trainers as developed for Ukraine can serve as inspiration for other countries that wish to attain sustainable HTA capacity.

Health Technology Assessment (HTA) guides healthcare decision-making, while Implementation Research (IR) addresses challenges in operationalizing these decisions. The SAVING (Sustainable Access and Delivery of New Vaccines in Ghana) Consortium aims to enhance health intervention delivery in Ghana, focusing on HTA evidence. This study identifies barriers to the application of HTA-related evidence (cost analysis) in coronavirus disease 2019 (COVID-19) vaccine deployment in Ghana. This qualitative exploratory study purposively selected 12 key stakeholders with high interest and power relating to COVID-19 vaccine deployment in Ghana. Through in-depth interviews, seven stakeholders from diverse sectors contributed insights into barriers to the application of HTA-related evidence. Thematic analysis was conducted with narrative reporting supported by direct quotes for substantiation. Six main barriers were identified: (1) timing and access to HTA reports, (2) technical complexities, (3) relevance of content, (4) political considerations and power dynamics, (5) health system fragmentation, and (6) poor responsiveness of decision-makers to research. Proposed solutions include engaging political decision-makers continuously, simplifying technical reports, aligning report content with policymakers' needs, reducing political considerations, enhancing capacity building, fostering health system cohesion, and improving responsiveness to research. HTA is vital for informed healthcare decisions. However, technical complexity, relevance of content, inappropriate timing, and lack of access to HTA reports, among other barriers, prevent the uptake of HTA findings. Continuous and improved engagement between HTA producers and policymakers, along with rapid production of HTA, has the potential to improve the uptake of HTA findings, even during public health emergencies.

Patient involvement is recognized as an integral component of health technology assessment (HTA), with patients' lived experiences offering valuable insights that enhance the relevance, transparency, and quality of healthcare decision-making. In line with a national shift toward patient-centered care, Singapore's Agency for Care Effectiveness (ACE) established formal processes for patient involvement in HTA in 2021. This paper describes ACE's structured approach to identifying relevant patient organizations, co-developing processes, and building capacity to support meaningful patient input. A stakeholder mapping exercise was undertaken to identify relevant local patient and volunteer organizations by searching the Singapore Charity Portal, hospital websites, search engines, and social media platforms. Identified organizations were screened against predefined criteria and contacted to determine their interest in ACE's work. A process and methods guide, including survey templates, plain language materials, and training resources were co-developed with local patient organizations, drawing on international best practices, contextualized to local patients' needs. ACE identified 106 patient organizations across 20 health conditions. During a pilot initiative between August and December 2022, 82 patients from 10 organizations provided input into 7 HTAs. Sustained participation continued afterwards, with patient testimonials submitted for 85 percent of HTAs in the first year, increasing to 89 percent in the second year. ACE's patient involvement processes have improved the relevance and acceptance of HTA recommendations. Ongoing engagement with patient organizations, systematic evaluation of impact, and refinement of processes will be crucial to ensure that patient input continues to inform and advance healthcare decision-making in Singapore.

This study aims to explore the perspectives on disinvestment of low-value care and interventions in Malaysia's healthcare system, with a focus on establishing the criteria for assessing disinvestment candidates, identifying potential barriers, and proposing strategies to improve the acceptance and effective implementation of disinvestment. Between March and May 2023, we conducted online, semistructured interviews with seventeen Malaysian healthcare stakeholders with different professional roles at various levels of governance and decision making. Participants were recruited through a mix of purposive and snowballing sampling. Interviews were transcribed verbatim and analyzed using inductive thematic approach in Atlas.ti. We identified four major themes: disinvestment as a catalyst for efficient resource allocation; disinvestment as a justifiable way of cutting budgets; challenges and barriers in implementation; and strategies for value-based assessment and effective implementation. Stakeholders viewed disinvestment both optimistically and skeptically in terms of its implementation but were unanimous in including equity as a key component in decision making. Practical challenges and uncertainty among healthcare professionals emerged as significant barriers to implementing disinvestment initiatives in Malaysia. Malaysian stakeholders viewed disinvestment as both an opportunity to improve resource allocation and a source of concern due to potential negative consequences and system readiness. This study identified strategies to support value-based assessment and implementation, underscoring the need for accountability and collaboration. Although current disinvestment efforts in Malaysia remain limited and undocumented, the thematic framework developed offers transferable insights and a structured lens for assessing readiness. These stakeholder-derived themes can guide other countries in designing transparent, equitable, and context-sensitive disinvestment processes.

Slovenia has engaged with Health Technology Assessment (HTA) for over two decades, but its system remains fragmented and underdeveloped. Until recently, responsibilities for evaluating health technologies were dispersed across multiple institutions without a central coordinating body or standardized methodology. Medicinal products have been subject to structured evaluation through the Health Insurance Institute of Slovenia, while other health technologies, including medical devices, diagnostics, and preventive interventions, have followed less consistent pathways under the Ministry of Health. The adoption of the European Union Health Technology Assessment Regulation), entering into force in January 2025, has provided new impetus for reform, requiring Slovenia to designate a national HTA body to participate in joint clinical assessments and align national processes with EU standards. A mixed-methods analysis combining a narrative overview of HTA in Slovenia with findings from two multi-stakeholder workshops held in 2025. These workshops, which convened Slovenian and international experts, policymakers, clinicians, and patient representatives, explored opportunities and challenges for developing a robust HTA framework. Key findings highlight the need to strengthen methodological capacity, introduce systematic stakeholder engagement, ensure transparency, and integrate real-world evidence into decision-making. Particular emphasis was placed on expanding HTA to medical devices, diagnostics, and digital health technologies, and on anticipating future innovations such as artificial intelligence. Slovenia now stands at a pivotal juncture. Establishing a central HTA body with a clear legal mandate, building national expertise, and leveraging regional and European collaboration is essential to creating a transparent, evidence-based, and patient-centred HTA system.

The use of Artificial Intelligence (AI) in Health Technology Assessment (HTA) activities presents an opportunity to enhance the efficiency, accuracy, and speed of HTA processes worldwide. However, the adoption of AI tools in HTA comes with diverse challenges and concerns that must be carefully managed to ensure their responsible, ethical, and effective deployment. The 2025 Health Technology Assessment international Global Policy Forum (GPF) informed GPF members of the integration of AI into HTA activities, with a particular focus on the use of Generative AI (GenAI). With the overarching goal of illuminating and inspiring tangible outputs and actionable recommendations, the event brought together a diverse range of interest holders to explore the opportunities and challenges of AI in HTA. This article summarizes the key discussions and themes that informed the GPF outcomes, including trust, human agency, and risk-based approaches, culminating in a proposed set of priority next steps for the HTA community regarding the integration of GenAI. It also highlights insights into the current state of digital transformation within HTA organizations and the life sciences industry, providing insights into where the field stands and where it is heading.

Health technology assessment (HTA) is increasingly recognized as a critical tool for evidence-informed decision-making in Eastern Europe and Central Asia (EECA), a region characterized by substantial diversity in health system maturity, financial resources, and institutional capacities. Building on the previous Eurasian HTA Initiative conducted a decade earlier, this study aimed to update the regional assessment of HTA implementation, expand country representation, and identify evolving strengths, weaknesses, opportunities, and threats affecting the advancement of HTA across the region. An online multilingual survey, informed by the original SWOT framework, was disseminated between August and October 2025 to experts from national authorities, HTA agencies, academia, and health sector stakeholders across eleven EECA countries. Twenty-two responses were analyzed descriptively. Key strengths included strong regional collaboration interest, growing availability of online HTA resources, and sustained global support. Major weaknesses centered on the limited trained HTA/EBM personnel and the absence of standardized national training programs. Opportunities reflected expanding interest in EBM, pressure from rising healthcare costs, and prospects for regional advocacy, educational exchanges, and international collaboration. Principal threats involved insufficient funding for capacity building, low policy-maker and clinician awareness, commercial influence from industry, and limited incentives for EBM uptake. Overall, respondents emphasized gradual progress in selected areas but persistent structural barriers requiring coordinated national and regional action.

Systematic literature reviews (SLRs) are essential for evidence synthesis in healthcare decision making, including health technology assessment (HTA), but their time and resource demands are substantial. Artificial intelligence (AI) may enhance efficiency of conducting SLRs, but its acceptance by HTA bodies remains underexplored. This SLR quantifies published health-related SLRs reporting AI use, identifies AI tools used at each SLR stage, and evaluates HTA guidance on AI in evidence synthesis. We searched Embase, Medline, and the Cochrane Library (up to 9 September 2025), supplemented by hand searches and reviews of HTA agency websites. Titles and abstracts were screened in Rayyan by a single reviewer, with full-text review confirming eligibility. Data were extracted and synthesized narratively along key themes. In total, 112 studies covering 111 unique SLRs were identified, reporting 134 implementations of 45 unique AI tools (29 publicly available; 16 custom-built). AI use has risen since 2013 and was most frequently applied during title and abstract screening (88 of the 134 implementations). Human oversight remained essential, with no fully autonomous AI reported. Three HTA agencies (CDA-AMC, IQWiG, NICE), EUnetHTA, JBI and Cochrane have provided guidance, indicating the formal integration of AI into HTA processes. This SLR provides a quantitative overview of AI use in health-related SLRs and current HTA guidance. These findings may inform development of clearer methodological recommendations and support integration of AI-assisted evidence synthesis in HTA submissions. Further research and policy development are needed to optimize its role in evidence synthesis and healthcare decision making.

Diabetes affects over 500 million people worldwide and contributes substantially to the environmental impact of health care, including carbon emissions and plastic waste. As healthcare systems globally aim to reduce their environmental footprint, there is a need to embed environmental sustainability into decision making and foster innovation in health and life sciences.This commentary outlines the environmental sustainability challenges and opportunities across the diabetes care pathway, highlighting innovations that reduce the demand for healthcare resources and associated environmental impact. We discuss the current and potential role of health technology assessment (HTA) agencies in promoting more sustainable health systems, by incorporating environmental considerations into the value assessment of technologies. Several approaches, such as integrated and parallel evaluation, are emerging to support this aim, whereas HTA agencies increasingly consider parameters of environmental life cycle assessment (eLCA), a comprehensive framework for evaluating the environmental sustainability of technology. Although a framework is evolving, early implementation by HTA bodies, for example, in the United Kingdom, Thailand, Canada, and Italy, highlights growing momentum. Moreover, sustainability policies at government and health system levels are developing globally, signaling opportunities to incorporate environmental sustainability in HTA (ESHTA).Given the scale of health care's environmental footprint, large disease areas offer critical opportunities for sustainable action. Diabetes, with its growing global prevalence, presents a particularly suitable domain for piloting the integration of environmental sustainability into HTA.

The European Union's Health Technology Assessment Regulation (HTAR) and its implementing acts foresee various forms of clinician involvement, such as joint clinical assessment or Joint Scientific Consultation. However, considering the varying preparedness levels for HTAR, as well as the understanding of the health technology assessment (HTA) principles and processes, this study aimed to evaluate the levels of HTA-related skills among medical and dental doctors in Croatia. A cross-sectional survey study was conducted among medical and dental medicine doctors in Croatia. The survey recorded respondents' relevant experience with HTA processes along with skill levels across the entire HTA process, mainly for acting as individual clinical experts or on behalf of their professional organizations, as well as potential HTA doers. Skill levels were evaluated using a 5-point scale (1 - no knowledge to 5 - full expertise). Among the 376 respondents included, only 6.1 percent had previous involvement in HTA, and 2.2 percent were familiar with HTAR. Related to the HTA process, the highest scores were observed in the understanding of key concepts and results of searching for studies, critical appraisal, study synthesis preparation, and ethics. The lowest scores were recorded in health economics, evidence grading, qualitative synthesis, and public/patient involvement. Respondents with prior research experience and those who reported frequent research use had significantly higher HTA skill scores. A significant gap in HTA-related skills highlights the need for targeted professional development programs and long-term educational reforms to build the capacity for various modes of involvement in HTA processes and their implementation.

Lasoo Health is an e-software in the early stages of development, designed to generate a consult report with the most probable headache diagnosis and treatment plan from direct patient input. A patient accesses the program with their consent and a referral from primary care. Digital consult is then reviewed by a medical specialist and then sent to the primary care provider to initiate care. This early health technology assessment (eHTA) assesses the potential impact of Lasoo Health on timely access to effective headache management, cost savings, and health outcomes compared to the current standard of care (SOC) in Alberta, Canada. We developed a discrete event simulation (DES) of headache diagnostic pathways for Albertan patients suffering from headaches. The model was parameterized using secondary data sources identified via relevant published literature and subject matter expert opinion. Cost-effectiveness was expressed from a societal perspective using the incremental net monetary benefit (iNMB) of Lasoo Health incorporated with the SOC compared to SOC alone over an analytical time frame of five years. Our analysis suggests that incorporating Lasoo Health into the SOC may reduce specialist assessment wait times by 70 percent and total per-patient costs by 7 percent. Using a willingness-to-pay (WTP) threshold of Canadian dollars (CAD) 50,000 (U.S. dollars (USD) $35,240), the iNMB per patient was estimated to be CAD 1,069 (USD $753). The benefits of implementing Lasoo Health over a 5-year period could translate to improved patient outcomes, reduced wait times for specialists, and lower productivity losses among headache patients.

Reducing health inequalities and improving health equity have become pressing priorities for health technology assessment (HTA) bodies and healthcare payers globally, particularly in light of the COVID-19 pandemic and its disproportionate impact on disadvantaged groups. Equity considerations are now being embedded across strategic frameworks and HTA processes in countries such as the UK, Canada, and Australia. Examples include NICE's Core20PLUS5 initiative and PBAC's policy shift allowing broader prescribing access to address care disparities. However, systematically incorporating quantitative equity measures into HTA presents significant challenges, given the diversity of equity subgroups and varying national contexts. At the 2024 CDA-AMC Symposium, we convened stakeholders to discuss the challenges and opportunities for integrating equity into HTA. Key insights included ICER's framework for embedding equity across the HTA lifecycle and NICE's evolving application of Distributional Cost-Effectiveness Analysis (DCEA), as demonstrated in the appraisal of exagamglogene autotemcel for beta-thalassemia. DCEA, while increasingly recognized, requires robust real-world data and clearer guidance on trade-offs between equity and efficiency. Manufacturers are aligning equity goals with ESG priorities but seek greater clarity from HTA bodies on how equity evidence influences decision-making. NICE and ICER emphasize the need for deliberative processes to capture equity dimensions not reflected in traditional cost-effectiveness analysis. Advancing health equity in HTA will require cross-sector collaboration to develop guidance, improve data infrastructure, and standardize methodologies. Equity-focused evidence generation across the "staircase of inequality" - from need to access and outcomes - can support more inclusive HTA and reimbursement decisions, ultimately fostering a fairer and more effective healthcare system.

Hospitals are at the front line of adopting new health technologies, yet decision-making is often hampered by insufficient evidence, limited context, and misaligned priorities. Hospital-based health technology assessment (HB-HTA) provides a structured mechanism to evaluate innovations at the institutional level. However, published accounts of HB-HTA implementation remain scarce, particularly in Asian contexts. We describe Singapore General Hospital's (SGH) approach to institutionalizing HB-HTA through a three-pronged strategy: (1) structured two-page narrative proposals to ensure clarity, rigor, and alignment with organizational priorities; (2) establishment of a dedicated HB-HTA team - the Impact Assessment, Program Evaluation, and Implementation Research team; and (3) targeted training programs to build capacity among clinical and managerial staff. Evaluation of the framework included formative feedback from proposers and senior leaders, surveys of participant satisfaction, and qualitative interviews. Between 2023 and 2024, SGH piloted and scaled the HB-HTA framework, reviewing 15 proposals exceeding USD $40 million across domains, including artificial intelligence, robotics, diagnostics, and therapeutic devices. Training workshops engaged 55 participants with high Net Promoter Scores (≥50 percent), while surveys of senior leadership showed that 91 percent were satisfied or very satisfied with the process. Qualitative feedback highlighted improved strategic alignment, transparency, and confidence in decision-making. SGH's experience demonstrates that embedding HB-HTA requires deliberate organizational design, leadership commitment, and stakeholder engagement. By combining concise narrative proposals with independent in-house assessments, hospitals can strengthen governance, foster accountability, and support value-driven innovation. This model offers a practical roadmap for institutions seeking to formalize HB-HTA within their decision-making processes.

Health technology management (HTM) involves systems designed to ensure the safe, effective, and cost-effective use of health technologies following reimbursement. This study examines the recommendations of Ireland's Health Service Executive-Drugs Group (HSE-DG), exploring the characteristics and patterns of positive or conditional positive recommendations and HTM-related requirements. We reviewed the minutes of HSE-DG meetings between January 2018 and December 2023. Data on medicines reviewed during this period were extracted into Microsoft Excel and analyzed narratively. Over the study period, the HSE-DG reviewed 192 medicines (including new medicines and new indications for existing medicines), of which 157 received positive (115) or conditional positive recommendations (42). Of these, thirty-three were subject to HTM conditions, typically involving a managed access protocol or a specific reimbursement application process. Due to inconsistent reporting of key information, quantitative analysis was not feasible. However, common characteristics among HTM-linked recommendations emerged. These included submissions for reimbursement targeting a subset of the licensed population (45.5 percent vs. 5.6 percent in non-HTM cases), designation as orphan medicines (39.4 percent vs. 29.8 percent), and having both first-in-class and new chemical entity designations (75.8 percent vs. 47.6 percent). Findings indicate an increasing trend toward positive/conditional positive reimbursement recommendations with HTM in the Irish setting, with an average of 21 percent of positive/conditional positive recommendations over the study period contingent on HTM. More granular and consistent reporting of key indicators would enable the determination of characteristics associated with reimbursement recommendations with HTM.

Cost-effectiveness analyses are used to help to inform resource-allocation decision-making in healthcare systems. The manufacturers of new health technologies may choose to employ "early cost-effectiveness analysis" (eCEA) to inform the technology development process in anticipation of a value-based assessment if and when the technology is launched. We aim to provide guidance on how eCEA can effectively inform health technology development processes, presenting novel methodological approaches to address key decision-making questions. We present three core health technology development questions that eCEAs can address, as well as recommendations for deriving and presenting insights from eCEA models. A hypothetical treatment for cutaneous squamous cell carcinoma (CSCC) called "dummymab" demonstrates the analytic techniques and presentation formats. We provide guidance for addressing: 1. What is a health technology's value-based price (VBP) under a range of scenarios? 2. To what extent do different attributes of the technology contribute to its value? 3. Regarding what model parameters is further evidence most valuable? A novel net benefit approach for value driver analysis provides more reliable estimates than traditional 'switch-on' methods by avoiding parameter interaction effects. The manufacturer-perspective value-of-information framework enables evidence prioritization aligned with commercial decision-making while maintaining cost-effectiveness principles. eCEA can systematically inform technology development through value-based price estimation, value driver identification, and evidence prioritization. Implementing development decision-making based on eCEA insights can foster alignment with value-based principles of HTA-orientated decision-making systems while supporting more efficient resource allocation in technology development.

Our objective was to identify key patterns and discuss the lessons learned from the use of real-world data (RWD) in the cost-effectiveness analyses (CEAs) of innovative health products (IHPs) as assessed by the French National Authority for Health from January 2016 to May 2023. A retrospective analysis was conducted on the use of RWD in the CEAs of IHPs. Our material included HAS assessments of CEAs and manufacturers' technical reports. The RWD studies were classified into eight categories, and a specific template was constructed to report and discuss their use in terms of predefined methodological aspects. In all, 88 percent (129/147) of the CEAs integrated RWD studies. Retrospective cohorts were the most frequently used kind of study in the CEAs, while prospective cohorts were mainly used to identify the analyzed population and to externally validate models. We identified opposing temporal trends in the use of cohort studies versus registries. Approximately 8 percent (10/129) of the CEAs could be adjudged as invalidated due to major limitations regarding RWD use (e.g., lack of relative effectiveness). We learned several lessons from the use of RWD in the HAS assessments of the CEAs of IHPs. Retrospective cohort studies were the most commonly used RWD source to populate CEA parameters of the CEAs regardless of the type of IHP, and their use has increased over time. The implementation of good practices for the use of RWD studies should improve the role of RWD in economic modeling and address uncertainties surrounding CEAs.

The Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR), which applies as of January 2025, introduces the Joint Clinical Assessment (JCA) for selected health technologies and establishes a stakeholder network. This study aims to evaluate the expected impact of the implementation of the HTAR from a multi-stakeholder perspective, using Italy as a case study. A scoping literature review was performed according to the PRISMA guidelines to inform the development of an interview guide. Target participants included Italian stakeholder representatives with an interest in the HTAR. One-on-one semi-structured interviews were conducted virtually at the end of 2024. The questions were categorized into three main topics: expected benefits and opportunities; foreseen risks or challenges; recommended actions. The interviews were transcribed verbatim and analyzed using thematic content analysis techniques. Thirteen participants included representatives from national and regional HTA bodies, health technology developers' associations, health professional associations, patient organizations, and HTA experts. The JCA is expected to enhance the quality of clinical assessment and to result in faster and more equitable access to health innovations. However, the timing will depend on the extent to which Member States require complementary analyses. Health technology developers benefit from submitting a single JCA dossier, but often cope with limited evidence and short-term deadlines. The interviewees recommended harmonizing evidence standards, investing in HTA education and training, and fostering strategic stakeholder collaborations. The process of harmonization induced by the HTAR is beneficial to standardize clinical assessment at the EU level, but needs to reconcile different stakeholder perspectives.