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.

The importance of Financial Distress (FD) for German cancer patients is rising and data on FD is increasingly being collected in clinical trials. However, the role of FD in German early benefit assessments (EBAs) remains unclear. We systematically analyze the role of FD in EBAs for oncology drugs in Germany by investigating how often and for what reasons FD is excluded for EBA by pharmaceutical companies, how often and in which ways FD is referenced in scientific assessments by German HTA authorities (IQWiG and G-BA), and how FD influences added benefit decisions.

Our analysis covered all completed, currently valid German EBAs of oncology drugs from 2011 to 2024. We calculated exclusion rates, reference rates and benefit decisions, stratified by drug type, FD results, exclusion and reference status. In qualitative analyses, we inductively categorized reasons for FD exclusion and types of FD references.

FD currently plays at most a subordinated role for German EBAs across all involved stakeholders. Almost half of dossier submissions excluded FD from EBA, even though data on FD was collected. The IQWiG referenced FD in only 25 percent of their scientific assessments. Furthermore, the G-BA referenced FD in only three out of 215 justifications of resolution. HTA authorities have divergent and inconsistent approaches to FD.

German HTA authorities should strengthen the role of patient-reported outcomes and provide clearer methodological guidance for integrating psychosocial dimensions such as FD. Future research should focus on refining measurement strategies to better capture the multidimensional nature of FD.

The rapid evolution of digital health technologies (DHTs) presents distinct challenges for health technology assessment (HTA). Existing HTA frameworks, largely designed for conventional health interventions, may not sufficiently address these unique complexities. This scoping review provides an overview of existing assessment frameworks for DHTs, analyzing their purpose and the guidance they offer within the domains of the EUnetHTA Core Model.

The review followed the Joanna Briggs Institute methodology and PRISMA-ScR guidelines. The literature was identified through searches in PubMed and Embase, covering publications from 2015 to 2024 in English or German, and was complemented by a manual hand search. The studies were screened and analyzed using Covidence, with data categorized inductively based on the EUnetHTA Core Model domains.

Of 3,576 screened records, 15 met inclusion criteria; an additional 45 frameworks were identified through hand searching, resulting in a total of 60 frameworks. Most frameworks focused on digital health applications (68 percent), while only a few addressed technologies such as artificial intelligence (2 percent). The frameworks primarily provide guidance on assessment, with varying focus on evidence requirements. The domains of the EUnetHTA Core Model were variably represented across the frameworks. Technical characteristics were most frequently addressed, while ethical, legal, and organizational domains received limited attention.

This review highlights the diversity of existing frameworks for DHT assessment. This emphasizes the potential relevance of a future standardized framework that contains explanations of the methodological approach to the assessment of DHTs and is modularly customizable depending on the type of technology.

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.

The overall aim is to understand the practices, views, and needs of health technology assessment (HTA) practitioners worldwide regarding the use of health-related quality of life (HRQoL) data for generating cost-effectiveness evidence.

We invited HTA practitioners in sixty countries to complete an online survey on their perspectives on the measurement and valuation of health. We performed descriptive analyses of the overall sample, examined response differences across six regions, and pooled responses to open-ended questions for content analysis.

A total of 238 individuals from 45 countries completed the survey, with a mean response number per country of 5.28 (SD: 4.45). Most responses came from public sector employees (seventy-two percent), and ninety percent were involved in cost-effectiveness-related work. The top three most frequently used utility instruments were EQ-5D, SF-6D, and EQ-5D-Y, and the elicitation methods were time trade-off, visual analogue scale, and standard gamble. Health-state preferences of the general public from another country were more frequently used than the preferences of the local public. Common data quality issues were poor sample representativeness and a small sample size of utility data. In Asia and Western Europe, the top-voted research priority was developing utility instruments that capture both healthcare and social care impact. In four regions, developing utility instruments for children was the second-highest research priority.

The survey addressed important knowledge gaps regarding current practices in measuring and valuing HRQoL in HTA and provided insights into HTA practitioners’ views on instruments, methods, and data-related challenges and needs for generating HRQoL evidence.

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.

While rapid health technology assessments (HTA) are important for decision makers, there is no universally accepted definition or standardized methods. The objective of this study was to analyze the content and conduct of published rapid and mini-HTA reports.

We conducted a cross-sectional analysis of rapid and mini-HTA reports identified from the International HTA Database (2014–April 2024) and supplementary searches of HTA agency websites. We extracted descriptive data on rapid HTA products; specifically, which traditional HTA domains were included or omitted, evidence synthesis methods, and approaches to interest-holder (formerly known as stakeholder) engagement. Data analysis was conducted in Stata.

We included 203 rapid HTA reports. Most frequently included HTA domains were clinical effectiveness (99 percent) and safety (82.3 percent). Legal aspects (12.3 percent) and budget impact analyses (10.8 percent) were less frequently reported. Across reports reviewing clinical effectiveness (n = 201), generic literature searches were the most predominantly self-reported evidence synthesis method (37.8 percent), with updates (1.5 percent) and overviews (2 percent) of systematic reviews less common. Cost-utility analyses were the most commonly self-reported form of economic evaluation (36.2 percent). Additionally, public consultations (68 percent) were the most commonly reported ways to engage with interest holders.

Our analysis highlights variations across rapid HTA reports and will contribute to wider research aiming to establish a clearer definition and framework of rapid HTAs and inform when and how rapid HTAs are performed. Clearer reporting and justification of simplifications in rapid HTA reports are needed.

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.

New technologies are being developed in a context of scarcity. Health technology assessment (HTA) aims to support decision makers in providing equitable and affordable access to effective innovations. This study aims to summarize the policy-related findings of a Horizon2020 project on innovating HTA methods and discuss their implications for the governance of HTA in Europe.

A thematic analysis of policy-oriented papers (n = 18) from the Next Generation Health Technology Assessment (HTx) project was carried out to summarize challenges and solutions. Subsequently, via an online survey and in a 2-day meeting, European and global stakeholders (n = 21) were invited to comment on these solutions and to prioritize future strategies.

Reported challenges included a lack of access to standardized data, differences in evidentiary needs, existing policy structures, and a lack of capacity and knowledge. Suggested solutions were capacity building, national and international dialogues, standardization, and increased European collaboration. Stakeholders had different expectations with respect to the likely success of these solutions.

Innovation of HTA requires alignment of evidentiary needs through dialogues, standardization through increased European collaboration, and capacity building. However, without additional investments in personnel capacity, HTA agencies must still prioritize some activities at the expense of others. Furthermore, although European collaboration is important, global alignment might be required to enforce standardization.

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.

Few studies report the evaluation of the use of Health Technology Assessment (HTA) organizations’ knowledge products.

To determine (a) the stakeholders’ use of the products disseminated by the ‘Institut national d’excellence en santé et en services sociaux’ (INESSS), and (b) the variability of use according to user characteristics and product properties.

A prospective web survey was performed. We included all participants who accessed INESSS products and voluntarily completed an online questionnaire from 1 January 2021, to 31 December 2022. For each rated product, the participants’ use and intention to use were documented using the content-validated Information Assessment Method (IAM) questionnaire. Descriptive statistical analyses were conducted.

A total of 7041 responses were gathered. After removing incomplete and ineligible responses, we were left with 5236 responses; 74.4 percent of responses were from women; 5014 (95.8 percent) reported that the product was relevant; of those, 4322 (82.5 percent) indicated that the respondent was satisfied; of those, 4096 (78.2 percent) reported that the product was used or had an intention to use the product. Regarding products’ use (n = 3023; 57.7 percent), there was no difference between regions with versus without medical faculties. Older participants were less likely to report using a product. Products with recommendations were more likely to be used, and healthcare professionals were more likely to use the products compared to other participants.

Current findings help identify audiences for targeted dissemination, guide user engagement strategies, and inform product refinement. Recommendation-containing products show the greatest uptake, particularly among younger professionals.

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.

Economic evaluation supports public funding decisions about the use of health technologies within the Portuguese National Health System (NHS). The methods guide for economic evaluation in Portugal serves both companies preparing economic evaluation submissions and the independent commission appraising the evidence submitted.

This article presents the revised methods guide for economic evaluation in Portugal. The revisions reflect advances in economic evaluation, updates to regulatory policies, and responses to the evolving economic context. The paper highlights the most significant changes to the guidance, comparing the new Portuguese guidelines to those from the United Kingdom and Canada. The discussion is framed around key comments received during public consultation.

The updated guidelines recommend cost-effectiveness analyses based on quality-adjusted life years and advocate for long-term modelling, a 4 percent discount rate, and a focus on NHS costs. New features include guidance on the identification and management of uncertainty within a dynamic appraisal process with regular contract negotiations (which can trigger reappraisals). The guide also covers how cost-effectiveness models, typically centrally developed, should be adapted to the Portuguese context. It highlights the key role of structured expert elicitation to address uncertainties in evidence, including those related to model adaptation.

The revision was developed through stakeholder consultations and aligns with international best practices, offering more explicit and transparent methods to support health resource allocation decisions.