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

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.

Since 2007, the Taiwan Health Technology Assessment (HTA) system has developed from a review process for new drug reimbursement into a core element of National Health Insurance (NHI) decision-making. This study examines Taiwan's development of a sustainable, learning-oriented HTA ecosystem. This article synthesizes more than 15 years of HTA development in Taiwan, highlighting recent advancements, including parallel reviews, temporary reimbursement pathways, managed entry agreements (MEAs), real-world evidence (RWE) guidelines, precision medicine frameworks, and structured health technology reassessment. Drawing on national policy sources, administrative datasets, and published evaluations, four interrelated domains were analyzed: institutional development and governance; access pathways for high cost and high clinical impact; infrastructure for evidence generation; and mechanisms to strengthen patient and patient organization involvement (PPI). In 2024, 196 rapid HTA assessments were completed, reflecting increased system capacity and methodological sophistication. This evolution builds on earlier HTA-driven policy experiences, including immune checkpoint inhibitors supported by HTA, MEA design, and national RWD collection. These developments formed the groundwork for managing uncertainty, assessing high-cost therapies, and supporting life cycle evidence. Parallel review improved timely access to novel medicines without compromising assessment rigor. The Taiwan Cancer Drugs Fund provided a structured model for temporary reimbursement and RWD collection. Formal PPI processes expanded the integration of patient voices. Taiwan's HTA system is transitioning into a learning health system that supports adaptive coverage, continuous reassessment, and sustainable access to new medical technologies. Developments offer guidance to health systems seeking to balance access, evidence development, and financial sustainability.

Health technology assessment (HTA) is a multidisciplinary, policy-oriented process designed to inform evidence-based, transparent, and value-based decision making in health systems. Across the Middle East and North Africa (MENA), HTA development remains heterogeneous and unevenly institutionalized. This manuscript reports on a Health Technology Assessment international (HTAi)-led Policy Dialogue designed to identify shared challenges, priorities, and opportunities to strengthen HTA systems across the region. Insights were generated through an in-person meeting held in Tunisia in 2025, alongside the HTAi MENA Regional Meeting. The dialogue was complemented by an online survey and a follow-up virtual meeting. Data sources included structured survey responses from experts across twelve countries and qualitative inputs from multi-stakeholder discussions involving policymakers, HTA practitioners, academics, and international organization representatives. Findings were synthesized descriptively to capture perceived challenges, priorities, and expectations for regional and international collaboration. Participants emphasized HTA's role in improving resource allocation, transparency, and access to high-value technologies. Key challenges included limited access to high-quality data, workforce capacity constraints, fragmented governance, and weak legal and institutional frameworks. The highest-ranked priorities were establishing formal legal mandates for all actors involved in HTA processes, building technical and system capacity (including institutional governance, processes, and coordination mechanisms), and strengthening health data infrastructure. Strong support emerged for regional cooperation through joint training, shared assessments, and HTA networking, alongside expectations for international organizations to play a catalytic role. HTA is gaining prominence across MENA, but most countries remain in early phases of institutional development. Progress will require coordinated action on governance, capacity, data systems, and implementation.

The European Union health technology assessment (HTA) regulation increases pressure on European HTA organizations' capacity and new domains of expertise continue to emerge quickly in the HTA field. Therefore, this study aimed to identify emerging competencies described in the literature and to update and verify an existing HTA competency framework, encompassing both process-related and domain-specific expertise for conducting HTA. Using a scoping review approach, PubMed, Embase, PsycINFO, ERIC, CINAHL, and Web of Science were searched from 1 January 2018 until 13 May 2024. The websites of HTA-related societies were searched on 22 April 2024. Documents describing competencies for HTA professionals were included. Deductive content analysis of the identified competencies was performed, utilizing the competencies from the original framework. A total of nineteen documents were included, consisting of six competency frameworks, one handbook, and twelve scientific articles. The identified competencies from these documents mapped appropriately to the original competency framework. New competencies within existing domains that emerged were related to organizational sustainability, patient and public involvement, real-world data, interpreting and developing HTA reports, and stakeholder identification. In addition, three new competency domains were identified, which were artificial intelligence use for HTA, environmental aspects, and performance and achievements. The newly identified competencies and competency domains highlight emerging areas of expertise for HTA professionals and need to be added to the original competency framework. An updated competency framework can support capacity building efforts and the development of training programs to ensure that HTA professionals are well-equipped to address current healthcare challenges.

Combining digital and traditional treatment elements as part of a hybrid care delivery model may strengthen the sustainability of mental health care. However, implementation problems permeate efforts of digitalizing routine care. The objective of this formative study is to explore current unmet stakeholder needs and the potential value of hybrid care models for the treatment of severe mental disorders, in order to guide further research and inform practical implementation strategies. We applied Step Up, an early health technology assessment (eHTA) framework. We performed (a) a template analysis of qualitative data from a stakeholder workshop mapping unmet needs, potential effects of hybrid care models, and conditions relevant for implementation and (b) exploratory economic simulations of the impact of increasing video consultation use in routine services on quantitative sustainability parameters. The template analysis revealed stakeholder-anticipated value from hybrid care models across all domains: patient, clinician, and next-of-kin user experiences; clinical variables; organizational setup; and economy. Two recommendations for enhancing implementation were identified: promoting nuanced perceptions of digitalized care and developing clinician incentives. The simulations demonstrated that a moderate increase in video consultations may impact clinical capacity, as well as economic and environmental sustainability. This study provides early decision support concerning hybrid care models during the conceptual stage of service innovation. It reveals that conservative changes toward digitalized practices can create new opportunities for organizing services and have a substantial impact on sustainability parameters. Successful implementation across clinical contexts requires continuous consideration of the clinician user perspective, starting from the conceptual phase.

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.

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.

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.

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.

Ontologies support transparent and reproducible conceptual modeling in Health Technology Assessment (HTA), but their population remains resource-intensive and reliant on expert input. This study evaluates the feasibility, reliability, and methodological implications of using generative artificial intelligence (GenAI) to populate ontology individuals for HTA applications. A factorial experimental framework was developed using the Ontology for Simulation Modeling (OSDi) and three HTA-relevant use cases of varying complexity. Two GenAI systems were evaluated under multiple experimental conditions, including prompting strategy, serialization format, and provision of supporting information. Generated ontology individuals were validated by an HTA expert and assessed across four quality dimensions: consistency, relevance, completeness, and adequacy. Multivariate and regression analyses were conducted to examine the effects of experimental factors on quality outcomes and hallucination likelihood. GenAI systems successfully generated ontology individuals across use cases, although performance varied by quality dimension and experimental condition. Iterative prompting significantly improved completeness, while serialization format strongly influenced reliability, with Turtle serialization associated with substantially lower hallucination likelihood compared with XML. Other factors showed dimension-specific effects, highlighting the multidimensional nature of ontology quality. Errors occurred more frequently in structurally complex ontology components, suggesting a relationship between ontological complexity and generative performance. GenAI-assisted ontology population can enhance the efficiency and scalability of HTA conceptual modeling, enhancing the agility of HTA agencies in exploratory phases. Its effective use requires structured prompting, appropriate representation formats, and expert validation. Further research should evaluate its impact on HTA decision modeling workflows and validation frameworks.

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.

Guideline development handbooks outline the methodology that authoring organizations use to create public health and clinical practice guidelines (CPGs). We created an Equity Assessment Tool (EquAT) for guideline development handbooks to identify areas of improvement and foster conversations. Sequential phases lead to tool development and face/content validation in this mixed-methods study. In phase 1, we reviewed the literature to generate a list of "essential elements" or tasks that are part of guideline development methodology, mapped "essential elements" with relevant equity concepts, and drafted our tool for use in reviewing guideline development handbooks. In phase 2, we surveyed experts for feedback on "essential elements" and explicit language for assessing equity within the tool and refined items. We piloted and finalized the tool based on feedback. We identified 18 essential elements within five domains of guideline development and created a draft EquAT. Twenty of 25 invited experts responded to the online survey for feedback on the tool. Most experts provided limited feedback, and the most common suggestion was adding clarifying language to the existing tool criteria for assessing equity. Ten experts participated in pilot testing the revised tool. We found a diversity of scores, and potential reasons might be due to the complexity of the tool, differences in equity frameworks, and a variety of expertise. We incorporated their feedback and finalized the tool. We developed and validated the EquAT, a tool to foster discussion among assessors about the extent of health equity considerations in guideline development handbooks.

Many European countries independently conduct horizon scanning activities. However, the costs, time, and resources required can be prohibitive. To address this, the International Horizon Scanning Initiative (IHSI) was launched in 2019. IHSI aims to facilitate decision-makers and payers in negotiating fair prices and preparing for potentially disruptive pharmaceuticals. IHSI developed the Joint Horizon Scanning Database, a repository of pharmaceuticals expected to enter the European market, and initiated a series of High Impact Reports (HIRs) to highlight pharmaceuticals that have the potential to significantly impact healthcare systems. This paper outlines the development of key performance indicators (KPIs) that can be used to evaluate IHSI's work. In close collaboration with representatives from IHSI member countries and its Executive Committee, the following KPIs were developed: "Number of IHSI member countries", "Embedding of IHSI in national health technology assessment procedures", "Database coverage", "Data completeness", "Data timeliness", "Accuracy of identifying disruptive pharmaceuticals", "Accuracy of identifying non-disruptive pharmaceuticals", "Use of HIRs in preparing for disruption to the healthcare system", and "Use of HIRs in price negotiations and financial arrangements". Among these, "Accuracy of identifying disruptive pharmaceuticals" was considered most important, followed by "Data timeliness" and "Data completeness". Additionally, based on consultations with nonmember countries, strategies for improvement were identified should the KPIs reveal areas for improvement. These include involving patients in the selection of pharmaceuticals and conducting reputation surveys alongside measuring KPIs. While the KPIs and strategies for improvement are specific to IHSI, they can be tailored to support other (international) horizon scanning initiatives.

Ethics has been recognized as an integral part of Health Technology Assessment (HTA) since its beginning. However, the integration of ethical analysis in HTA practice has been limited and challenging. Members of the Health Technology Assessment international (HTAi) Interest Group (IG) for Ethical Issues in HTA reflected upon this situation, during a workshop and online meetings, to identify which challenges hinder integration of ethics in HTA and how to move the discipline forward. In this article, we present the results of that discussion, describing different ways that ethical analysis can occupy a more central role in HTA practice. We also describe developments in HTA that create a momentum for reflecting upon such integral role for ethical analysis in HTA: artificial intelligence-based health technologies, changes in the evidence landscape, assessing the environmental impact of health technology, and the new EU regulation on HTA.

The role of health technology assessment (HTA) is evolving. Once seen primarily as a gatekeeper, HTA is increasingly viewed as a potential shaper of health system transformation. The first plenary session of the HTA International 2025 Annual Meeting explored the potential for HTA to adopt this broader role. Drawing on perspectives from across the globe, it was discussed how HTA can help shape more equitable, responsive, and sustainable health systems by informing benefit package design, supporting universal health coverage, and addressing systemic inequities from a societal perspective. Audience polling and live commentary underscored a shared sense of urgency, as well as recognition of the methodological, political, and practical constraints to this evolution. Rather than a binary choice, a continuum of roles was suggested depending on the context in which HTA is applied. Ultimately, HTA can shape health systems - not through ambition alone, but through evidence-informed, inclusive, and context-aware decision-making.

Patient involvement in health technology assessment (HTA) at the organizational level remains relatively underreported in Asia. In 2022, Singapore's Agency for Care Effectiveness (ACE) established a Consumer Panel to provide strategic advice on strengthening patient participation in HTA processes and policy development. The Panel comprises representatives from local patient organizations, collectively covering a range of health conditions and bringing extensive lived experience within Singapore's healthcare system. This Perspective outlines ACE's approach to forming the Panel and highlights its contributions during the inaugural term, including co-developing patient involvement processes, supporting health literacy efforts, and fostering collaboration between ACE and patient communities. Panel members' reflections on their role and future directions for advancing patient partnership in HTA are also discussed. Beyond improving the quality and relevance of ACE's work, the Consumer Panel's achievements provide a valuable example for health authorities in other countries seeking to meaningfully involve patients at the organizational level.