Carol Stephanie Chua Tan-Lim, Ian Theodore G Cabaluna, Myzelle Anne J Infantado-Alejandro, Mark Dale S Imbag, Larraine Franchesca L Lopez, Natasha Ann R Esteban-Ipac, Anna Angelica Macalalad-Josue, Howell Henrian G Bayona, Aldrich Ivan Lois D Burog, Kim L Cochon, Marissa M Alejandria
{"title":"Development of the Philippine guidance document for the use of real-world evidence for clinical assessment of health technologies.","authors":"Carol Stephanie Chua Tan-Lim, Ian Theodore G Cabaluna, Myzelle Anne J Infantado-Alejandro, Mark Dale S Imbag, Larraine Franchesca L Lopez, Natasha Ann R Esteban-Ipac, Anna Angelica Macalalad-Josue, Howell Henrian G Bayona, Aldrich Ivan Lois D Burog, Kim L Cochon, Marissa M Alejandria","doi":"10.1017/S0266462325100512","DOIUrl":"https://doi.org/10.1017/S0266462325100512","url":null,"abstract":"<p><strong>Objectives: </strong>Under the Universal Health Care Act of the Philippines, all health technologies should undergo health technology assessment. This manuscript details the process of the development of the Philippine guidance document for the use of real-world evidence (RWE) in the clinical evaluation of health technologies.</p><p><strong>Methods: </strong>This study consisted of two phases. Phase 1 was a comprehensive, systematic review of all available HTA methods guides and literature related to the use of RWE in the clinical evaluation of health technologies. Based on the results of the review, a draft HTA methods guide on the use of RWE was created. Phase 2 was a validation study by expert consultation through key informant interviews (KIIs), and pilot assessment of the methods guide.</p><p><strong>Results: </strong>Seventy-nine articles and nine guidance papers were included, with pertinent information extracted and organized into sections. The first draft covered definitions of RWE, guidance for RWE utilization, scoping and selecting RWE, critical appraisal, data extraction, and synthesis and analysis of RWE. Changes were made to this draft based on the KIIs and pilot assessment results to produce the final output of the methods guide.</p><p><strong>Conclusions: </strong>This document describes the process of creating a Philippine guidance document that covers the definition of RWE and the appropriate methods for conducting systematic search, screening, critical appraisal, data extraction, data analysis, and synthesis of RWE.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e72"},"PeriodicalIF":3.1,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244625","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}
Annabel Griffiths, Lorna Dunning, Karen Facey, Dina Jankovic, Carlos González Malla, Eric Low, Michela Meregaglia, Fabian Schmidt, Kevin Wilson, Sheela Upadhyaya, Noa Chapman, Chloe Zentai, Sari Wright, Isabelle Newell
{"title":"RECOMMENDED METHODS FOR THE COLLECTION OF CLINICAL EXPERT JUDGMENT IN RARE DISEASES: GENERATING EVIDENCE TO SUPPORT REIMBURSEMENT OF ORPHAN DRUGS.","authors":"Annabel Griffiths, Lorna Dunning, Karen Facey, Dina Jankovic, Carlos González Malla, Eric Low, Michela Meregaglia, Fabian Schmidt, Kevin Wilson, Sheela Upadhyaya, Noa Chapman, Chloe Zentai, Sari Wright, Isabelle Newell","doi":"10.1017/S0266462325100457","DOIUrl":"https://doi.org/10.1017/S0266462325100457","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-33"},"PeriodicalIF":3.1,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238545","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":"RELEVANT DOMAINS FOR HEALTH TECHNOLOGY ASSESSMENT IN MEDICAL DEVICE REIMBURSEMENT INTO BRAZIL'S UNIFIED HEALTH SYSTEM: A SURVEY AND DELPHI PANEL STUDY ON STAKEHOLDER PREFERENCES.","authors":"Fotini Santos Toscas, Leidy Anne Alves Teixeira, Evelinda Trindade, Marisa Santos, Handerson Jorge Dourado Leite, Denizar Vianna Araujo","doi":"10.1017/S0266462325100561","DOIUrl":"https://doi.org/10.1017/S0266462325100561","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-30"},"PeriodicalIF":3.1,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238575","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}
Ramiro Gilardino, Debjani Mueller, Nicole Mittmann, Franz Benjamin Pichler
{"title":"Reframing Early Health Technology Assessment Through a Lifecycle Lens: Commentary on \"Defining Early Health Technology Assessment: Building Consensus Using Delphi Technique\".","authors":"Ramiro Gilardino, Debjani Mueller, Nicole Mittmann, Franz Benjamin Pichler","doi":"10.1017/S0266462325100548","DOIUrl":"https://doi.org/10.1017/S0266462325100548","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-5"},"PeriodicalIF":3.1,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238572","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}
Rhiannon C Reising, Mohamed El Alili, Merel L Kimman, Mickael Hiligsmann
{"title":"Integrating Environmental Aspects into Health Technology Assessment: A Qualitative Study among Dutch Stakeholders.","authors":"Rhiannon C Reising, Mohamed El Alili, Merel L Kimman, Mickael Hiligsmann","doi":"10.1017/S0266462325100536","DOIUrl":"https://doi.org/10.1017/S0266462325100536","url":null,"abstract":"<p><strong>Background: </strong>The Dutch National Health Care Institute (ZIN) advises the Dutch Minister of Health on the basic benefit package using Health Technology Assessment (HTA), focusing on necessity, clinical effectiveness, cost-effectiveness, and feasibility. Despite the huge environmental impact of the healthcare sector, this impact is not taken into consideration. Several methodological approaches to integrate the environmental impact into HTA have been proposed, including information conduit, integrated evaluation, parallel evaluation, and environment-focused evaluation. There is significant uncertainty as to which approach is the most appropriate. Therefore, it is important to understand stakeholders' perspectives on these approaches.</p><p><strong>Objectives: </strong>To explore Dutch stakeholders' perspectives on integrating environmental impacts into HTA and assess preferred methods and challenges.</p><p><strong>Methods: </strong>A qualitative study using a focus group with members from ZIN (n = 7) and individual interviews (n = 7) with experts in HTA, market access, and reimbursement. Interviews were transcribed and analyzed thematically.</p><p><strong>Results: </strong>Stakeholders highlighted the importance of addressing environmental impacts such as pharmaceutical pollution, greenhouse gas emissions, and waste. Integrated and parallel evaluations were preferred, but barriers such as data gaps, methodological complexity, and lack of guidelines were noted.</p><p><strong>Conclusion: </strong>Incorporating environmental impacts into HTA is crucial but requires clear guidelines, better data, and stakeholder collaboration to support sustainable healthcare practices.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e71"},"PeriodicalIF":3.1,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232578","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}
Drew Carter, Mah Laka, Yuan Gao, Olivia Choi, David Tamblyn, Tracy Merlin
{"title":"Engaging stakeholders along health technology assessment pathways: a scoping review of international practice.","authors":"Drew Carter, Mah Laka, Yuan Gao, Olivia Choi, David Tamblyn, Tracy Merlin","doi":"10.1017/S0266462325100494","DOIUrl":"https://doi.org/10.1017/S0266462325100494","url":null,"abstract":"<p><strong>Objectives: </strong>Health technology assessment (HTA) has been characterized as a complex adaptive system that centrally features stakeholder interactions. This article provides an overview of current practices in HTA stakeholder engagement concerning medicines.</p><p><strong>Methods: </strong>We conducted a scoping review of English-language sources published between 2018 and 2023, including 66 peer-reviewed articles and 264 gray literature sources describing stakeholder involvement in HTA processes relating to medicines.</p><p><strong>Results: </strong>Industry is commonly permitted to provide a submission for funding, though the modes and time points of industry engagement are many. Clinician and patient engagement are regarded as especially important with increased intervention complexity and innovation. Stakeholder engagement is perhaps mostly conducted to enhance the collation and interpretation of evidence, not necessarily to increase the legitimacy of the HTA process or give stakeholders influence over a decision that affects them. Patients are mostly engaged through broader public consultation. Sometimes they work directly with other stakeholders. Problems with patient engagement include challenges with recruitment, time, and resource constraints. Stakeholder groups can also differ in how they view and prioritize public and patient engagement. Public engagement is often limited to a matter of transparency and public accountability, but the reasons to undertake public engagement are numerous and varied. They include gaining input on affordability or prioritization issues.</p><p><strong>Conclusions: </strong>HTA decision-making committees should commit to publicly communicating how they considered and made use of various stakeholder inputs. This could build trust and confidence in the committees and guide the public and patients on the information that committees find helpful.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e69"},"PeriodicalIF":3.1,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145191635","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}
Richard D A Hudson, Thierry Rigoine de Fougerolles, Flora Leadley, Mersha Chetty, Priscille De La Tour
{"title":"Modeling the greenhouse gas emissions of an immunization program against respiratory syncytial virus in infants in the United Kingdom.","authors":"Richard D A Hudson, Thierry Rigoine de Fougerolles, Flora Leadley, Mersha Chetty, Priscille De La Tour","doi":"10.1017/S0266462325100524","DOIUrl":"10.1017/S0266462325100524","url":null,"abstract":"<p><strong>Objectives: </strong>The healthcare system accounts for 4 percent of United Kingdom (UK) greenhouse gas (GHG) emissions annually. In response to climate change, the National Health Service (NHS) is calling for less carbon-intensive care practices through prevention. Respiratory Syncytial Virus (RSV), a leading cause of infant hospitalization, currently has no widespread immunization program in the UK. This study estimates the impact on GHG emissions generated within the care pathway from an immunization against RSV in all infants in the UK with nirsevimab, a new monoclonal antibody used in prophylaxis.</p><p><strong>Methods: </strong>A novel approach was applied, mapping care pathway emissions from immunization and avoiding RSV-related primary and secondary care burden. Avoided healthcare resources were estimated using a published health economic model for nirsevimab versus standard of care (SoC), which is characterized as receiving palivizumab or having no immunization intervention, assuming different universal immunization scenarios. NHS England GHG emission factors were applied to each health outcome to measure the GHG emissions associated with a nirsevimab versus SoC strategy.</p><p><strong>Results: </strong>Compared with SoC, a universal immunization program using nirsevimab leads to avoided GHG emissions, amounting to ~22 kilotons of CO<sub>2</sub> equivalents per year, with immunizing all UK infants at birth leading to the greatest reduction. About 40 percent of avoided emissions were from reductions in inpatient hospitalizations.</p><p><strong>Conclusions: </strong>This study shows how prevention can deliver benefits to people, NHS system capacity, and the environment. However, avoided patient care pathway emissions must be considered alongside drug lifecycle emissions, which are not included here.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e73"},"PeriodicalIF":3.1,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112972","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":"Toward including environmental sustainability in Health Technology Assessment.","authors":"Anke-Peggy Holtorf, Melissa Pegg, Debjani Mueller, Nicola McMeekin","doi":"10.1017/S0266462325100500","DOIUrl":"10.1017/S0266462325100500","url":null,"abstract":"<p><strong>Introduction: </strong>The life cycle of health technologies contribute to air pollution, ecotoxicity, and resource depletion, impacting the environment and human health. Increasing healthcare resource use globally increases emissions that accelerate climate change and negatively affect the health of current and future generations.Health Technology Assessment (HTA) should inform decision makers to prioritize the adoption of technologies demonstrating value in terms of health benefits, costs, and other relevant dimensions such as environmental sustainability.This paper reports on a multistakeholder approach to guiding an international working group for Environmental Sustainability in Health Technology Assessment (ESHTA) that has been formed by Health Technology Assessment international.</p><p><strong>Methods: </strong>A multistakeholder online workshop was held with 32 participants in May 2024 to define the critical issues to be considered. The resulting report underwent consultation among the ESHTA members and in a broader group of 90 additional worldwide stakeholder representatives.</p><p><strong>Results: </strong>The workshop participants recognized defining frameworks, mechanisms, and tools for embedding environmental sustainability into HTA as an opportunity to support sustainable development and quality improvement in healthcare. Achieving this requires (1) consensus on what environmental sustainability in healthcare means, (2) reconcilement with other healthcare and environmental policies, and (3) methods that are useful and applicable within HTA frameworks.</p><p><strong>Conclusion: </strong>This novel collaboration aims to align the global HTA community on the role of environmental sustainability in HTA. The report provides a path for the way forward for incorporating environmental sustainability into HTA based on broad perspectives from global multistakeholders.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e70"},"PeriodicalIF":3.1,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113097","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":"Early health technology assessment: current and future perspectives from a health technology assessment agency.","authors":"David Jarrom","doi":"10.1017/S0266462325100482","DOIUrl":"https://doi.org/10.1017/S0266462325100482","url":null,"abstract":"<p><p>Health technology assessment (HTA) can occur at different stages of a technology's lifecycle. In the accompanying paper, Grutters and colleagues present a consensus definition of \"early HTA\" as a health technology assessment conducted to inform decisions about subsequent development, research, and/or investment by explicitly evaluating the potential value of a conceptual or actual health technology. Early HTA is particularly relevant to non-medicine technologies, which are often developed more iteratively than medicines. This article explores some of the ways in which early HTA is already being conducted on non-medicine technologies in the United Kingdom, as well as future perspectives and possible challenges in using early HTA.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e68"},"PeriodicalIF":3.1,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145075163","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}
Lisa Masucci, Diedron Lewis, Jiahao Zhao, Caitlin Carter, Kelvin K W Chan, William W L Wong
{"title":"The use of real-world evidence among healthcare payers: a scoping review.","authors":"Lisa Masucci, Diedron Lewis, Jiahao Zhao, Caitlin Carter, Kelvin K W Chan, William W L Wong","doi":"10.1017/S0266462325100445","DOIUrl":"10.1017/S0266462325100445","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world evidence (RWE) is increasingly used to assess and make regulatory decisions on health technologies. However, its application in healthcare payer decision-making is less well-known.</p><p><strong>Objectives: </strong>The objectives of this study were to (i) review the recent literature on how RWE has been used by healthcare payers, (ii) highlight barriers that limit the use of RWE in payer decision making, and (iii) explore how RWE has been used in various funding arrangements between payers and manufacturers. The benefits of utilizing RWE are also discussed.</p><p><strong>Methods: </strong>A scoping review was conducted on articles published between 2014 and 2025 in PubMed (Medline), OVID EMBASE, Cochrane Library, and ProQuest Dissertations and Theses Global. Eligible articles were those written in English that discussed the use of real-world evidence among healthcare payers/decision-makers for health technology reimbursement decisions.</p><p><strong>Results: </strong>Nineteen articles were selected for full-text review based on the inclusion criteria. The review highlighted payers' interest in incorporating RWE into funding and reimbursement decisions to address uncertainty in the performance of new health technologies. However, a lack of standards for collecting, analyzing, and reporting RWE limits its use. Little is known about how RWE is used in reimbursement decisions since contractual arrangements between payers and manufacturers are confidential.</p><p><strong>Conclusions: </strong>Although payers are interested in using RWE to inform funding and reimbursement decisions, there are concerns regarding the scientific rigor used to generate such evidence. Having more insight into the contractual arrangements between payers and manufacturers would help to better understand how RWE informs these agreements.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e67"},"PeriodicalIF":3.1,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450548/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145040204","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}