David Aluga, Claire Gorry, Michael Barry, Paula Byrne, Paddy Gillespie, Susan M Smith
{"title":"Unveiling trends: insights into medicines reimbursement recommendations and health technology management in Ireland (2018-2023).","authors":"David Aluga, Claire Gorry, Michael Barry, Paula Byrne, Paddy Gillespie, Susan M Smith","doi":"10.1017/S0266462326103717","DOIUrl":"10.1017/S0266462326103717","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e42"},"PeriodicalIF":3.1,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13125769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147623007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Antonio Migliore, Mouna Jameleddine, Ann Single, Debjani Mueller, Nabil Harzallah, Nicola Vicari, Zakia Ines Harzallah, George Valiotis
{"title":"Advancing Health Technology Assessment in the Middle East and North Africa: Insights and Outcomes from the 2025 HTAi Regional Meeting.","authors":"Antonio Migliore, Mouna Jameleddine, Ann Single, Debjani Mueller, Nabil Harzallah, Nicola Vicari, Zakia Ines Harzallah, George Valiotis","doi":"10.1017/S0266462326103663","DOIUrl":"https://doi.org/10.1017/S0266462326103663","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-10"},"PeriodicalIF":3.1,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147581233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cost-utility of screening with liquid cytology or p16/Ki67 dual stain in women identified in cervical cancer triage with non 16/18 HR-HPV.","authors":"Isandra Meirelles, Marcia Pinto, Fabio Russomano","doi":"10.1017/S0266462326103675","DOIUrl":"10.1017/S0266462326103675","url":null,"abstract":"<p><strong>Objectives: </strong>To perform a cost-utility analysis of the p16/Ki67 dual stain compared to liquid cytology (LC) in the screening of women aged 25-60 years with high-risk papillomavirus (HR-HPV) non 16/18, from the perspective of the Sistema Único de Saúde (SUS) of Brazil.</p><p><strong>Methods: </strong>A Markov-coupled decision tree cost-utility analysis model was developed for the follow-up of a hypothetical cohort of 1,000 women in the age group, in health states that simulated the natural progression of cervical cancer. The time horizon was lifetime with a discount rate of 5 percent for costs and benefits. To survey the resources used for the procedures involved, the recommendations of the Brazilian Guidelines for Cervical Cancer Screening were considered. Most of the cost data were obtained from SUS administrative and public databases. Deterministic and probabilistic sensitivity analyses were carried out.</p><p><strong>Results: </strong>Screening with p16/Ki67 outperformed LC, resulting in an incremental gain of 2.5 quality-adjusted life years (QALYs) and an incremental cost-effectiveness ratio of R$31.40/QALY (range R$12.98-62.90/QALY), well below the reference value of R$40,000/QALY.</p><p><strong>Conclusions: </strong>The p16/Ki67 test proved to be cost-effective in screening women with non 16/18 HR-HPV. The results can help Brazilian managers plan and make decisions about incorporating technologies for triage considering the use of HPV tests in cervical cancer screening.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e48"},"PeriodicalIF":3.1,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Health technology assessment in Eastern Europe and Central Asia: an updated SWOT analysis.","authors":"Rabia Sucu, Antonio Migliore, Nicola Vicari, Esra Meltem Koç, Alima Almadiyeva","doi":"10.1017/S0266462326103614","DOIUrl":"10.1017/S0266462326103614","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e31"},"PeriodicalIF":3.1,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13071842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jaime L Peters, Tristan Snowsill, Sophie Robinson, Edward Griffin, Christopher Hyde
{"title":"Considering research waste in economic evaluations of low-dose computed tomography screening for lung cancer.","authors":"Jaime L Peters, Tristan Snowsill, Sophie Robinson, Edward Griffin, Christopher Hyde","doi":"10.1017/S0266462326103687","DOIUrl":"10.1017/S0266462326103687","url":null,"abstract":"<p><p>With the ongoing discussion around the implementation of low-dose computed tomography (LDCT) screening for lung cancer, increasing numbers of model-based economic evaluations have been conducted. We systematically reviewed the published literature for economic evaluations of LDCT screening for lung cancer in people at high risk, updating this review in 2024. We identified a total of 57 economic evaluations; two-thirds of which developed <i>de novo</i> decision-analytic models. In our most recent update, of the 22 economic evaluations identified, only one used a model published before 2021. There may be advantages to developing new models, but the huge possibility of research waste cannot be ignored. Better quality of reporting (both in terms of clarity and completeness), improving the availability of existing models, and comparative analysis of different models can help to advance modeling methods in areas of complexity, such as screening for cancer. Ultimately, this should lead to policy decisions based on the best available evidence.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e45"},"PeriodicalIF":3.1,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sok Huang Teo, Fiona Pearce, Tang Ching Lau, Ritu Jain, Ping-Tee Tan
{"title":"Establishing a Consumer Panel to Inform Health Technology Assessment Processes and Policy: impact and insights from Singapore's experience.","authors":"Sok Huang Teo, Fiona Pearce, Tang Ching Lau, Ritu Jain, Ping-Tee Tan","doi":"10.1017/S0266462326103481","DOIUrl":"10.1017/S0266462326103481","url":null,"abstract":"<p><p>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 <i>Perspective</i> 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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e30"},"PeriodicalIF":3.1,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13071841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147520827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sophie Pauge, John Andrew Grosser, Birthe Aufenberg, Wolfgang Greiner
{"title":"The role of financial distress as a patient-relevant endpoint in early benefit assessments for oncology drugs: a mixed-methods document analysis.","authors":"Sophie Pauge, John Andrew Grosser, Birthe Aufenberg, Wolfgang Greiner","doi":"10.1017/S0266462326103626","DOIUrl":"10.1017/S0266462326103626","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e27"},"PeriodicalIF":3.1,"publicationDate":"2026-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13071838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147503894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hendrikje Rödiger, Laura Franziska Marie Wittich, Reinhard Jeindl, Yui Hidaka, Dionne Bowie, Juan Carlos Rejón-Parrilla, Zoe Garrett, Reinhard Busse, Cornelia Henschke
{"title":"Frameworks for assessing digital health technologies: a scoping review.","authors":"Hendrikje Rödiger, Laura Franziska Marie Wittich, Reinhard Jeindl, Yui Hidaka, Dionne Bowie, Juan Carlos Rejón-Parrilla, Zoe Garrett, Reinhard Busse, Cornelia Henschke","doi":"10.1017/S0266462326103523","DOIUrl":"10.1017/S0266462326103523","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e24"},"PeriodicalIF":3.1,"publicationDate":"2026-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13071847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tess Martin, Giovanny Arbelaez-Garces, Christophe Roussel, Nicolas Martelli, Olivier Marcellin
{"title":"Organizational impact in healthcare in France: a decade of insights but chicken and egg situation.","authors":"Tess Martin, Giovanny Arbelaez-Garces, Christophe Roussel, Nicolas Martelli, Olivier Marcellin","doi":"10.1017/S026646232610347X","DOIUrl":"10.1017/S026646232610347X","url":null,"abstract":"<p><strong>Objectives: </strong>Over the past decade, organizational impact (OI) has gained recognition as a key dimension in health technology assessment (HTA) in France, particularly for medical devices. Despite the publication of a national framework by the Haute Autorité de Santé in 2020, the absence of standardized methodologies continues to hinder its integration into decision making.</p><p><strong>Methods: </strong>This commentary article traces the evolution of OI in French HTA, highlights real-world examples, and analyzes existing methodological tools, many adapted from other disciplines, that could enhance OI assessment.</p><p><strong>Results: </strong>It emphasizes the need for flexible, context-sensitive approaches and proposes recommendations to improve the robustness, reproducibility, and relevance of OI evaluations.</p><p><strong>Conclusions: </strong>The article also explores the implications for pricing and reimbursement decisions, as well as hospital-based HTA practices, aiming to support more structured and evidence-informed integration of organizational considerations into HTA processes in France and beyond.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e25"},"PeriodicalIF":3.1,"publicationDate":"2026-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12979018/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147377480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ping-Tee Tan, Fiona Pearce, Kiah Shen Quek, Sok Huang Teo, Jen Hun Koh
{"title":"Patient involvement in health technology assessment: a new process in Singapore.","authors":"Ping-Tee Tan, Fiona Pearce, Kiah Shen Quek, Sok Huang Teo, Jen Hun Koh","doi":"10.1017/S0266462326103584","DOIUrl":"10.1017/S0266462326103584","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e36"},"PeriodicalIF":3.1,"publicationDate":"2026-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13071846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147365094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}