Disinvestment and early awareness

The Disinvestment and Early Awareness IG (DEA IG) is dedicated to: (i) collaboration, sharing knowledge, and expertise; (ii) development of methods for prioritizing and assessing emerging, obsolete, or low-value technologies; and (iii) the practical application of de-adoption or disinvestment by health systems. It was established in 2014 under a memorandum of understanding between HTAi and the EuroScan International Network, a pioneer in the field and long-standing partner of HTAi. The DEA IG focuses on horizon scanning, early awareness, and disinvestment across the technology lifecycle (Reference Trowman, Migliore and Ollendorf3;Reference Pichler, Boysen and Mittmann4). The lifecycle of technologies spans initial development, market introduction, widespread adoption, potential obsolescence, and eventual withdrawal (Reference Gutiérrez-Ibarluzea, Chiumente and Dauben5). Early awareness is essential for identifying and assessing emerging technologies before they become widely adopted. By proactively identifying promising technologies, healthcare systems can inform decisions about their adoption, prioritizing those with demonstrated clinical and economic benefits. Early awareness and alert systems are designed to identify innovative technologies with the potential for significant impacts on healthcare. At the other end of the spectrum, disinvestment is intended to ensure that technologies that are outdated, ineffective, or no longer cost-effective are removed from practice. European HTA agencies have increasingly recognized the importance of disinvestment as a strategy to improve healthcare efficiency (Reference Calabrò, La Torre and de Waure6). In Italy, for example, structured frameworks have led to more efficient spending (Reference Cadeddu, Regazzi and Di Brino7). Others have proposed evidence-based frameworks for identifying technologies of no- or low-added value (Reference Esandi, Gutiérrez-Ibarluzea, Ibargoyen-Roteta and Godman8). Nevertheless, disinvestment is often impeded in practice by the inertia of long-standing or routinized administrative, clinical, and payment practices, as well as various ethical, political, and economic concerns.

Early career network

The HTAi Early Career Network (ECN IG) was established in 2011 to connect and facilitate networking among three main groups: members who are early in their HTA careers, including recent graduates of programs in HTA or such related fields as epidemiology, health economics, and public health; professionals who are approaching HTA later in their careers; and experienced HTA professionals. Among its functions, the ECN IG promotes standardized curricula, develops mentorship programs, and advocates formal training pathways in HTA. The “Newcomer’s Guide to HTA,” a recent initiative of this IG, comprises a curated collection of resources for navigating the HTA landscape, ranging from introductory overviews to detailed methods and processes (9). Another ongoing initiative of the ECN IG is a mentoring program that matches senior members of the society with newcomers.

As HTA continues to evolve in response to technological advancements, policy shifts, and healthcare challenges, there is a growing need to ensure that early career professionals receive the necessary training, mentorship, and resources to develop their expertise. One of the key challenges in HTA education is the lack of standardized competencies and training programs across different regions and institutions. This includes a common understanding of HTA competencies to enhance educational and training programs globally, supported by a well-defined competency framework to help early career professionals navigate the multidisciplinary nature of HTA (Reference Mueller, Gutierrez-Ibarluzea, Chiumente and Oortwijn10). In addition to technical competencies, networking and professional development opportunities are critical for early-career professionals. Many young HTA practitioners face difficulties in establishing connections within the field, accessing career advancement opportunities, and participating in international collaborations (Reference Migliore, Mueller and Oortwijn11). Supporting early-career professionals in HTA is essential for ensuring growth and long-term sustainability of the field. By promoting and delivering mentorship, training, and career development initiatives, HTAi can help cultivate a new generation of HTA leaders who are well-equipped to navigate complex healthcare challenges. This can help early-career professionals build confidence in their analytical and decision-making skills while fostering HTA globally.

Ethical issues in HTA

The Interest Group for Ethical Issues in HTA (EIG) was established initially by the International Network of Agencies in Health Technology Assessment, then converted into a formal HTAi IG in 2005. The EIG brings together those involved in HTA (including staff from HTA bodies, industry, government, academia, and patients and citizens) who have an interest in the explicit and formal identification and analysis of ethical issues pertaining to HTA. The EIG aims to establish and strengthen connections with others in related fields, for example, patient and citizen involvement in HTA and the role of philosophy in HTA; share good practices and related expertise in methodologies and tools for identifying and addressing ethical issues in HTA (Reference Single, Scott and Wale12).

The dynamic nature of medical innovation requires ongoing attention to its potential ethical implications, addressing issues such as patient autonomy, equity, and the balance between individual and societal benefits, as highlighted by an article by the EIG leadership (Reference Refolo, Duthie and Hofmann13). The earliest contributions in the field emphasize that ethical inquiry in HTA is not optional, but a fundamental component, influencing how technologies are evaluated and implemented in healthcare systems. Values such as procedural and social justice, human rights, and public trust are intrinsically central to HTA evaluations and should be acknowledged and incorporated into HTA decision making accordingly. A structured approach to ethical evaluation enables healthcare systems to make more informed and justifiable decisions about certain technologies that may challenge societal norms. For instance, technologies used in neonatology may present unique ethical dilemmas, including decision making on life-sustaining treatments, resource allocation, and parental involvement (Reference Di Pietro14). Similarly, ethical complexities may emerge in assessing advanced therapy medicinal products (ATMPs), such as gene and cell therapy, which often involve high costs, uncertain long-term outcomes, and difficult value judgments (Reference Gonçalves15). A recent study highlighted how HTA bodies struggle with assessing these therapies due to their particular risk–benefit profiles and ethical implications (Reference Drummond, Ciani and Fornaro16). Another recent study published by the EIG leadership (Reference Refolo, Bond and Bloemen17) highlighted a scenario where competencies for ethical analysis in HTA are often lacking or inconsistently applied. The authors emphasized that although ethical considerations are recognized as important within HTA, there are significant gaps in formal training, standardized methodologies, and the integration of ethical expertise into HTA processes. Their study outlined the core competencies necessary for ethics experts in HTA and defined essential skills, knowledge areas, and methodological approaches.

Hospital-based HTA

Established in 2006, the Hospital-Based HTA Interest Group (HB-HTA IG) gathers professionals interested or involved in the use of an HTA logic at healthcare institutions for supporting both managerial and clinical decision-making processes. It provides a dialogue opportunity for members who are producers or users of HTA within hospitals; promotes awareness and knowledge of hospital-based HTA by sharing its principles, values, methods, and best practices; and identifies trends to support integration of national and hospital-based HTA programs. The collective experiences empower the role of hospital-based HTA in shaping the future of hospital healthcare systems globally.

Hospital decision makers, including managers and clinicians, are gatekeepers for many innovative technologies (Reference Martin, Guercio and Besseau18). Hospital-based HTA faces institutional, regulatory, and methodological challenges that require a specialized platform for discussion, collaboration, and knowledge exchange (Reference Galdino, Camargo and Elias19).

International experiences demonstrate that hospital-based HTA is evolving, with diverse models tailored to different healthcare systems. Institutionalization of hospital-based HTA often calls for cooperation among stakeholders, including policy makers, healthcare professionals, and industry representatives (Reference Gałązka-Sobotka, Kowalska-Bobko, Lach, Mela, Furman and Lipska20). The Adopting Hospital Based Health Technology Assessment (AdHopHTA) project was among the pioneers in the field, drawing on contributions from the HB-HTA-IG (Reference Cicchetti, Iacopino and Coretti21). It revealed that hospitals often struggle with resource constraints and the complexity of technology assessments, and that HTA in different hospital settings must be tailored subject to organizational structures, available financial and human resources, and other institutional challenges. Strategies to overcome these barriers have been proposed recently by the HB-HTA leadership, including the development of training programs, strengthening interdisciplinary collaboration, and integrating hospital-based HTA into national health policies (Reference Lipska, Di Bidino and Niewada22).

HTA in developing countries

Established in 2008, the HTA in Developing Countries IG (DCIG) aims to connect members interested in the early implementation of HTA in their countries. It aims to share experiences, activities, resources, and opportunities for education and training, and stimulate discussion about new ideas, needs, challenges, and solutions where HTA is in early development or adoption. Activities led by DCIG highlighted that patient communities may be key advocates for HTA uptake due to their interest in universal health coverage and fair and transparent methods for healthcare decision making.

Implementing HTA in low- or middle-income countries (LMICs) presents such challenges as limited institutional capacity, inadequate funding, and insufficient stakeholder engagement. Research led by DCIG leaders has highlighted that HTA adoption is limited by the absence of a well-defined policy framework and institutional support. In South Africa, for example, attempts to integrate HTA into the healthcare system have been hindered by fragmented decision making, a lack of standardized methodologies, and constraints in human resources (Reference Mueller23). Similar issues were highlighted in parts of Eastern Europe and Central Asia where political instability, capacity shortages, and fragmented data sources posed systemic barriers to the successful implementation of HTA (Reference Migliore, Vicari, Turk and Sucu24). Although not specific to LMICs, achieving stakeholder engagement can be especially challenging in those contexts. The work of DCIG has shown that patient/public involvement remains limited in LMICs due to a lack of awareness, inadequate communication channels, and cultural barriers (Reference Holtorf, Mueller and Sousa25). International collaboration, including technical support, is essential to overcome these barriers and scale up HTA capacity in LMICs (Reference Mueller, Alouane, Jameleddine and Lenoir-Wijnkoop26).

Information retrieval

Since its inception in 2005, the Information Retrieval Interest Group (IRG) has been convening members with an active interest in information resources for HTA, sharing expertise, practical experience, and related tools and processes for advancing literature searching and synthesis.

HTA relies on high-quality evidence synthesis to inform policy and clinical decision making. At its core is information retrieval, a critical yet often underappreciated discipline that ensures comprehensive, accurate, and unbiased identification of relevant literature. The increasing complexity of health information sources and evolving methodologies in evidence synthesis highlight the value of information specialists in planning, conducting, and reporting systematic reviews in HTA. However, although statisticians and other professionals are routinely involved and acknowledged in systematic reviews, information specialists are often underutilized (Reference Waffenschmidt and Bender27). International initiatives have demonstrated the value of shared expertise and harmonized approaches in conducting literature searches. The work done within the European Network for Health Technology Assessment in the development of collaborative methods, processes, and infrastructures to improve information retrieval across European HTA agencies deserves to be mentioned (Reference Waffenschmidt, van Amsterdam-Lunze, Gomez, Rehrmann, Harboe and Hausner28). Peer review and quality assurance in HTA information retrieval and synthesis have also improved transparency, reproducibility, and validity in the field (Reference Lefebvre and Duffy29). IRG initiatives such as the SuRe Info (Summarized Research in Information Retrieval for HTA) framework (Reference Isojärvi and Glanville30) provide updated guidance on evidence-based searching for HTA professionals.

Medical devices

The Medical Devices Interest Group (MDIG), established in 2019, aims to ensure that best practices in HTA of medical nondrug technologies are shared, providing a space for all stakeholders to discuss the strengths, weaknesses, challenges, and opportunities of introducing medical device innovation into healthcare systems under the responsibility of increasing patient outcomes and lowering system costs.

Medical devices encompass a broad spectrum, ranging from simple instruments to complex digital systems, each with distinct developmental, regulatory, and clinical considerations. Assessment of medical devices is distinguished by devices’ iterative development and shorter life cycles, which often result in limited availability of long-term clinical data at the time of evaluation. Traditional HTA frameworks, primarily designed for pharmaceuticals, typically do not adequately capture the dynamic nature of medical device innovation. This underscores the need for adapted assessment methodologies that can accommodate continuous improvements and real-world performance data (Reference Schnell-Inderst, Mayer and Lauterberg31). In fact, a recent review (Reference Basu, Eggington, Hallas and Strachan32) indicated that HTA methods, guidelines, and reports often lack comprehensive inclusion of medical device-specific characteristics. This omission can lead to assessments that do not fully account for factors such as user dependency, learning curves, and context-specific performance, potentially diminishing the accuracy and relevance of HTA findings for medical devices. Moreover, organizational and contextual differences in device deployment can confound device assessment (Reference Bloemen and Oortwijn33). Furthermore, national and international regulation of medical devices is evolving, with increasing emphasis on postmarket evidence generation and continuous monitoring to increase safety and effectiveness, especially for high-risk devices (Reference Aranda, Dobrzynska, Rosario-Lozano, Rejón-Parrilla, Epstein and Blasco-Amaro34). Additionally, the increasing integration of digital health solutions further complicates medical device assessment. Challenges in evaluating digital medical devices highlight (Reference Trancart, Riche and Disset35) the need for specialized HTA approaches to assess these technologies, including such factors as cybersecurity, real-world data integration, and patient engagement (Reference Trancart, Riche and Disset35).

Patient and citizen involvement

The Patient and Citizen Involvement in HTA Interest Group (PCIG) was established in 2005 to promote and develop robust methodologies to incorporate these perspectives into HTAs and share best practices in participation in HTA. This includes co-developing recommendations for good practice (Reference Holtorf, Bertelsen, Jarke, Dutarte, Scalabrini and Strammiello36) and promoting consistent terminology to aid understanding and research. Since 2010, the IG has defined patient involvement as two complementary but equally important approaches: (i) research into patient aspects: needs, preferences, experiences, and perspectives and (ii) patient participation in HTA, across individual HTAs, overarching processes, and HTA policy (Reference Facey, Boivin and Gracia37). As involvement varies across jurisdictions due to the essential influence of goals and settings, PCIG has led the development of practical tools to support uptake, such as Delphi-study-derived HTAi Values and Quality Standards for Patient Involvement and submission and summary templates that have been translated and adapted for local needs internationally (38).

It has been argued that framing HTA through patient perspectives leads to a more holistic understanding of what constitutes value in healthcare as, beyond clinical effectiveness and cost-effectiveness, patients often emphasize treatment accessibility, disease burden, and the psychosocial impact of interventions (Reference Gunn, Regeer and Zuiderent-Jerak39). Although studies have highlighted the contribution of patient knowledge to HTA (Reference Livingstone, Verdiel and Crosbie40), especially in addressing gaps and uncertainties in the traditional evidence or validating evidence and assumptions, its impact can be unclear. Beyond the challenges of transparency and the multiple domains considered in HTA deliberations, the PCIG’s research highlighted that a lack of evaluation (Reference Weeks, Polisena and Scott41) and different stakeholder perspectives of impact (Reference Single, Facey, Livingstone and Silva42) are barriers to understanding patient involvement’s influence. In response, the PCIG undertook a study to collate stories of impact from the perspectives of patients, technology developers, and HTA bodies. An analysis of these stories identified three domains of impact (on the patient/patient organization, on the HTA body, and on the HTA recommendations or results), which form a practical framework to support increased evaluation in the field (Reference Lopez Gousset, Silveira Silva, Holtorf, Toledo-Chávarri and Single43).

Despite the potential benefits of patient involvement in HTA, its uptake varies. Patient participation is more widely employed than undertaking research into patient aspects or integrating published evidence in this area. Another PCIG study suggested that HTA bodies were unsure of how to make use of patient preference data (Reference Germeni, Fifer and Hiligsmann44). An enduring question is whether HTA processes are inherently limited in incorporating patient knowledge because patient perspectives have usually been absent during process and method development. A PCIG study of patient involvement at the organizational level of HTA in five jurisdictions observed growing patient involvement in instances where patients had participated in governance, defining patient involvement processes, developing HTA processes and methods, and/or capacity building (Reference Nabarette, Chastenay, Dupont, Ganache and Single45).

Public health

The Public Health IG (PHIG) is dedicated to raising awareness of the importance of HTA in (i) evaluating public health interventions for promoting health, preventing diseases and preserving and/or ensuring sustainable healthcare and social infrastructures; (ii) facilitating the development and application of appropriate methodologies and HTA approaches in the area of public health; and (iii) engaging with diverse stakeholders to strengthen intrasectorial cooperation of major importance in the area of HTA and public health. The PHIG was established in 2019 by consolidating the Initiatives for Public Health Outcomes Research and Measurement IG and the Assessment of Vaccines Programs IG.

HTA has traditionally focused on pharmaceuticals and medical devices, often neglecting the evaluation of broader public health measures such as vaccination programs, infection control strategies, and digital health interventions, partly due to difficulties in quantifying benefits such as disease prevention, health promotion, and economic savings from reduced healthcare utilization (Reference Stojanovic, Wübbeler, Geis, Reviriego, Gutiérrez-Ibarluzea and Lenoir-Wijnkoop46). Certainly, the COVID-19 pandemic has exemplified the importance of integrating HTA into public health decision making (Reference Hasdeu, Beliera, Alvarez and Sánchez Viamonte47). Vaccination programs are among the most impactful public health interventions, yet their assessment presents particular challenges, as factors such as herd immunity, epidemiological trends, and long-term cost savings must be considered (Reference Largeron, D’Agostino and Chapman48). Another urgent issue in HTA of public health concerns the growing threat of antimicrobial resistance (AMR), including discrepancies in how new antibiotics are assessed and valued across different national HTA agencies.

Given the global nature of AMR, there is a need for coordinated HTA approaches that incentivize antibiotic development while promoting responsible stewardship (Reference Dumont, Lengliné and Delorme49). The rise of digital public health interventions, such as mobile health apps, telemedicine platforms, and digital disease surveillance tools, further necessitates specialized HTA approaches where usability, scalability, interoperability, and data security need to be considered (Reference Gudi, Raj, Jahn, Siebert and Brand50).

Rare diseases

The Rare Diseases IG (RDIG), the newest HTAi IGs, was established in 2023 to address the challenges that arise in determining value in technologies for diseases that are often genetic, of predominantly childhood onset, and chronic. The RDIG shares good practices in the generation and interpretation of evidence in rare disease populations and explores how HTA can consider wider aspects of value in rare disease populations within the context of fairness to society. The RDIG aims to develop awareness of the specific challenges associated with studying rare disease populations, not just in terms of small populations but in understanding natural history and disease progression, and paucity of knowledge about optimal endpoints given complex disease manifestations. The initial focus of RDIG is on four main areas: (i) dissemination of relevant information and initiatives in HTA of rare diseases, (ii) characterization of the issues with rare diseases and their implications for HTA, (iii) understanding evidence generation and interpretation in the context of the rare diseases complexity, and (iv) economic modeling methods used to assess treatments for rare diseases.

Given the increasing availability of high-cost treatments for rare conditions, ensuring that HTA frameworks account for the specificities of rare disease evaluation is essential. A recent German study (Reference Kranz, McGauran, Ünal and Kaiser51) highlighted that orphan drugs frequently fail to show added benefit under the local HTA process due to evidence gaps, leading to persistent unmet medical needs. This underscores the need for innovative assessment approaches, such as the use of RWE, adaptive clinical trials, and surrogate endpoints, to ensure that promising treatments are not dismissed due to methodological limitations. Relevant inconsistencies in reimbursement policies have been reported across different healthcare systems in Europe (Reference Jakubowski, Holko and Nowak52) and other contexts (Reference Felippini, Biglia, Lima and Aguiar53), where some systems prioritize cost-effectiveness, whereas others emphasize broader social and ethical considerations. All of these disparities in clinical and nonclinical evaluation criteria affect access to treatment. Value assessment frameworks tailored to rare diseases have been proposed, incorporating such factors as disease severity, treatment innovation, and societal impact to better capture the value of orphan drugs (Reference Biglia, Felippini, Ribeiro, Lima and Aguiar54). Additionally, there is growing recognition that societal preferences, including ethical and equity considerations, must be integrated into rare disease HTA (Reference Vásquez, Hall and Merlo55).

Real-world evidence and artificial intelligence

The Real-world Evidence and Artificial Intelligence Interest Group (RWE&AI IG) was established in 2020 to serve as a discussion forum where members can provide insights, exchange ideas, and make collective decisions about subjects related to the RWE and artificial intelligence (AI). The RWE&AI IG aims to: (i) educate evidence developers and assessors, including practitioners, researchers and regulators, on how AI and machine learning (ML) are and will be used, and on RWE generation and utilization in the context of regulatory and HTA dossiers; (ii) identify and engage people with interest and expertise in RWE, AI, and HTA; and (iii) explore further use in collaborative projects, including facilitation of cross-border and interdisciplinary collaboration and identify early cases of best practice.

The integration of RWE into AI-driven methodologies presents both opportunities and challenges for HTA processes. RWE offers insights into the long-term effectiveness, safety, and cost-effectiveness of health technologies in routine clinical practice. However, its use is still met with methodological and regulatory challenges related to collection, analysis, and quality standards (Reference Oortwijn, Sampietro-Colom and Trowman56), and concerns about data quality, standardization, and transparency have been highlighted as typical barriers to incorporating RWE in HTA (Reference Zisis, Pavi, Geitona and Athanasakis57). One of the key issues in leveraging RWE is harmonizing data from different sources, such as electronic health records, registries, and claims databases, to improve the robustness of HTA. In this context, inconsistencies in data collection and reporting remain significant obstacles (Reference Graili, Guertin, Chan and Tadrous58). In parallel, technologies that are enabled by AI-driven predictive modeling, risk stratification, and personalization of medicine are changing how evidence is generated, which then in turn is transforming how evidence is evaluated in HTA. However, algorithmic bias, transparency, and regulatory approval raise concerns requiring improved validation methodologies and clearer guidelines (Reference Zemplényi, Tachkov and Balkanyi59). In the meantime, as AI is already integral to many healthcare technologies, existing HTA frameworks may be unsuitable for assessing these products. Validated frameworks for assessing AI-enabled technologies may prove to be critical for ensuring their safe and effective implementation. Furthermore, these technologies would benefit from dynamic HTA approaches that can account for continuous algorithm updates and related changes (Reference Di Bidino, Daugbjerg, Papavero, Haraldsen, Cicchetti and Sacchini60).