Hannes Kahrass, Antje Schnarr, Clovis Mariano Faggion, Marcel Mertz
{"title":"Ethics domains in full health technology assessment reports: an attempt to begin mapping the field.","authors":"Hannes Kahrass, Antje Schnarr, Clovis Mariano Faggion, Marcel Mertz","doi":"10.1017/S026646232400480X","DOIUrl":"10.1017/S026646232400480X","url":null,"abstract":"<p><strong>Introduction: </strong>Health technology assessment (HTA) reports are written for healthcare decision makers, particularly in relation to reimbursement/pricing, and are intended to assess clinical effectiveness, safety, and cost. Four additional domains are further considered in what is called a \"full HTA\": ethical, legal, social, and organizational aspects. The ethical aspects have long been the subject of debate regarding how they should be processed. It would be important if the following questions could be answered: Who publishes full HTA reports and how? Which methods are used in the ethics domain? What kind of results do they produce? However, such a \"mapping of the field\" turns out to be difficult. Despite the existence of international HTA registers, we were not able to compile a comprehensive sample of full HTA reports. Therefore, the aim of our study was rather to explore a) substantially: Which information can be expected to be (easily) found, which can only be obtained with considerable effort, and which remain (for the time being) in the dark? And b) methodologically: Is it possible to do meaningful meta-research in this field?</p><p><strong>Methods and results: </strong>In the attempt to explore the possibilities of meta-research, we were able to track down and analyze thirty-nine full HTA reports from six countries.</p><p><strong>Conclusions: </strong>While not representative of the whole field, this analysis shows the possibilities and challenges to meta-research, but nonetheless also provides some substantial insight into the characteristics of such reports, with a particular focus on the methods used to process ethical aspects.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e22"},"PeriodicalIF":2.6,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803284","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}
Daniel Asfaw Erku, Ararso Desalegn, Tesfaye Mesele Mekonnen, Erimias Dessie, Firmaye Bogale Wolde, Sabit Ababor Ababulgu, Paul A Scuffham, Damian Walker, Rabia Sucu, Samuel Abera
{"title":"Towards institutionalizing HTA in Ethiopia: using a political economy analysis to explore stakeholder perspectives and assessing capacity needs.","authors":"Daniel Asfaw Erku, Ararso Desalegn, Tesfaye Mesele Mekonnen, Erimias Dessie, Firmaye Bogale Wolde, Sabit Ababor Ababulgu, Paul A Scuffham, Damian Walker, Rabia Sucu, Samuel Abera","doi":"10.1017/S0266462325000170","DOIUrl":"https://doi.org/10.1017/S0266462325000170","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-19"},"PeriodicalIF":2.6,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772291","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}
Linda A Murphy, Ron Akehurst, David Cunningham, Gérard de Pouvourville, Oriol Solà-Morales
{"title":"Real-world evidence to support health technology assessment and payer decision making: is it now or never?","authors":"Linda A Murphy, Ron Akehurst, David Cunningham, Gérard de Pouvourville, Oriol Solà-Morales","doi":"10.1017/S0266462325000145","DOIUrl":"https://doi.org/10.1017/S0266462325000145","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this policy article is twofold: (i) to provide a summary and update of recent important policy developments, in particular relevant guidance on the use of real-world data/real-world evidence (RWD/RWE) by health technology assessment (HTA) bodies and (ii) to set out our policy recommendations on how the different elements of an \"RWE framework\" we have previously developed could support, further enhance and facilitate the use of RWE for HTA purposes and by HTA bodies and payers.</p><p><strong>Methods: </strong>We undertook a targeted review and analysis of recent important policy developments. The aim was to build on our recommendations from previous work on the \"RWE Framework,\" and consider how the relevant tools from our Framework can further enhance and facilitate the use of RWE for HTA purposes and by HTA bodies/payers.</p><p><strong>Results: </strong>We provide eight conditions that we argue would, in combination, constitute the optimal use and acceptance of RWD/RWE for HTA. We believe that, should the eight conditions hold, RWD/RWE would enable more efficient access to medicines and healthcare technologies for patients.</p><p><strong>Conclusions: </strong>High-quality, fit-for-purpose RWD/RWE can and should be used more frequently in HTA. Multi-stakeholder and cross-geography collaborative partnerships are needed to align on best practices to optimize the evidence that needs to be generated to satisfy all stakeholders' needs.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e20"},"PeriodicalIF":2.6,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752444","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}
Rosiane Simeon, Abdulah Al Ameer, Janet H Roberts, Shehzad Ali, Kumanan Wilson, Ian D Graham, Peter Tugwell, Vivian Welch
{"title":"PATIENT ENGAGEMENT FOR THE DEVELOPMENT OF EQUITY-FOCUSED HEALTH TECHNOLOGY ASSESSMENT (HTA) RECOMMENDATIONS: A CASE STUDY OF TWO CANADIAN HTA ORGANIZATIONS.","authors":"Rosiane Simeon, Abdulah Al Ameer, Janet H Roberts, Shehzad Ali, Kumanan Wilson, Ian D Graham, Peter Tugwell, Vivian Welch","doi":"10.1017/S0266462325000182","DOIUrl":"https://doi.org/10.1017/S0266462325000182","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-28"},"PeriodicalIF":2.6,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729977","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}
Marcus Sellars, Joanna Coast, Emily Lancsar, Cam Donaldson, Stacy M Carter
{"title":"\"Blanket rules just don't work\": Qualitative exploration of the relative value of child and adult Quality Adjusted Life Year (QALY) gains for health technology assessment.","authors":"Marcus Sellars, Joanna Coast, Emily Lancsar, Cam Donaldson, Stacy M Carter","doi":"10.1017/S0266462325000194","DOIUrl":"https://doi.org/10.1017/S0266462325000194","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-34"},"PeriodicalIF":2.6,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729973","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}
Arie Rahadi, Rizki Tsalatshita Khair Mahardya, Putri Listiani, Eva Herlinawaty, Ryan Rachmad Nugraha, Dani Ramdhani Budiman, Christian Suharlim
{"title":"Calibration of transition probabilities to model survival of adjuvant trastuzumab for early breast cancer in Indonesia.","authors":"Arie Rahadi, Rizki Tsalatshita Khair Mahardya, Putri Listiani, Eva Herlinawaty, Ryan Rachmad Nugraha, Dani Ramdhani Budiman, Christian Suharlim","doi":"10.1017/S0266462325000157","DOIUrl":"10.1017/S0266462325000157","url":null,"abstract":"<p><strong>Objectives: </strong>Cost-effectiveness models fully informed by real-world epidemiological parameters yield the best results, but they are costly to obtain. Model calibration using real-world data/evidence (RWD/E) on routine health indicators can provide an alternative to improve the validity and acceptability of the results. We calibrated the transition probabilities of the reference chemotherapy treatment using RWE on patient overall survival (OS) to model the survival benefit of adjuvant trastuzumab in Indonesia.</p><p><strong>Methods: </strong>A Markov model comprising four health states was initially parameterized using the reference-treatment transition probabilities, obtained from published international evidence. We then calibrated these probabilities, targeting a 2-year OS of 86.11 percent from the RWE sourced from hospital registries. We compared projected OS duration and life-years gained (LYG) before and after calibration for the Nelder-Mead, Bound Optimization BY Quadratic Approximation, and generalized reduced gradient (GRG) nonlinear optimization methods.</p><p><strong>Results: </strong>The pre-calibrated transition probabilities overestimated the 2-year OS (92.25 percent). GRG nonlinear performed best and had the smallest difference with the RWD/E OS. After calibration, the projected OS duration was significantly lower than their pre-calibrated estimates across all optimization methods for both standard chemotherapy (~7.50 vs. 11.00 years) and adjuvant trastuzumab (~9.50 vs. 12.94 years). LYG measures were, however, similar (~2 years) for the pre-calibrated and calibrated models.</p><p><strong>Conclusions: </strong>RWD/E calibration resulted in realistically lower survival estimates. Despite the little difference in LYG, calibration is useful to adapt external evidence commonly used to derive transition probabilities to the policy context, thereby enhancing the validity and acceptability of the modeling results.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e18"},"PeriodicalIF":2.6,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11955306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709708","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}
Rossella Di Bidino, Iga Lipska, Monika Kukla, Marina von Pinoci, Sara Consilia Papavero, Marco Marchetti, Laura Sampietro-Colom, Americo Cicchetti
{"title":"The potential of the hospital-based Health Technology Assessment: Results of a world-wide survey.","authors":"Rossella Di Bidino, Iga Lipska, Monika Kukla, Marina von Pinoci, Sara Consilia Papavero, Marco Marchetti, Laura Sampietro-Colom, Americo Cicchetti","doi":"10.1017/S0266462325000108","DOIUrl":"10.1017/S0266462325000108","url":null,"abstract":"<p><strong>Objectives: </strong>Hospital-Based Health Technology Assessment (HB-HTA) is a heterogeneous phenomenon constantly evolving to respond to the needs of decision-makers at the hospital level. In 2023, The HB-HTA Interest Group of Health Technology Assessment International (HTAi) surveyed HB-HTA activities with the aim to provide an updated description of the actual scenario.</p><p><strong>Methods: </strong>An online survey was conducted to gather data on the main characteristics of hospitals, HB-HTA activities, outputs, role in the decision-making processes, dissemination and training activities, and their interaction and collaboration with other stakeholders and HTA-related regulations. Finally, the survey collected feedback on the perception of and current barriers to HB-HTA. Three categories of responders were identified: Both hospitals performing and not performing HTA and policymakers.</p><p><strong>Results: </strong>Eighty-seven responses were collected from twenty-eight countries. Nearly half of the responders (<i>n</i> = 41) conducted HB-HTA, whereas eighteen consisted of hospitals not performing HTA, and twenty-eight were policy makers. HB-HTA was performed mainly in hospitals with >500 beds. HB-HTA units were organized in 40 percent of cases as an \"independent group.\" The survey showed that HTA units could contribute to all the steps of the decision-making processes, whereas the impact of the assessments on the decisions was mainly perceived as a medium. Furthermore, HB-HTA was not seen as a duplication of effort, even without specific regulations.</p><p><strong>Conclusions: </strong>The survey highlighted the role of HB-HTA in hospital decision-making supporting the vision of HB-HTA as one of the actors in the HTA ecosystem, the success of which depends on collaboration with other stakeholders.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e19"},"PeriodicalIF":2.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657150","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":"Navigating change: a comparative analysis of health technology assessment reforms across agencies - processes, drivers, and interdependencies.","authors":"Gayathri Kumar, Priscila Radu, Patricia Cubi-Molla, Martina Garau, Eleanor Bell, Jia Pan, Ramiro Gilardino, Julie Van Bavel, Agnes Brandtmüller, Katherine Nelson, Melinda Goodall","doi":"10.1017/S0266462325000133","DOIUrl":"10.1017/S0266462325000133","url":null,"abstract":"<p><strong>Objectives: </strong>Health technology assessment (HTA) is a critical part of healthcare decision making in many countries. Changes in Methods and Processes (M&P) of HTA agencies can affect the time and degree of patient access to treatments. Published literature focuses on the different M&P adopted by HTA agencies, rather than on how these have come about over time. Our study investigates key HTA reforms and explores their drivers and interdependencies in a set of HTA agencies in Europe, Asia-Pacific, and North America.</p><p><strong>Methods: </strong>We conducted a targeted literature review on M&P guidelines and subsequent changes to those, for 14 HTA agencies. We supplemented and validated initial findings with 29 semi-structured interviews with country-specific experts. We used analytical tools to create process maps, proactivity and influence networks, and clusters of HTA agencies.</p><p><strong>Results: </strong>We found that processes leading to M&P reforms follow similar steps across HTA agencies. The three most important drivers to reforms were HTA practice and guidelines in other countries; the healthcare policy, legal, and political context within the agency's country; and experience of challenges in the assessment by the HTA body itself. International collaborations have the potential to accelerate the evolution of HTA systems and the implementation of reforms.</p><p><strong>Conclusion: </strong>We identified PBAC (Australia), CDA-AMC (Canada), NICE (England), IQWiG (Germany), and ZIN (the Netherlands) as HTA agencies that are catalysts of HTA reforms as well as internationally influential. International collaborations may represent a useful route to accelerate changes as long as they ensure wide stakeholder engagement at an early stage.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e21"},"PeriodicalIF":2.6,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624807","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}
Richmond Owusu, Brian Adu Asare, Genevieve Cecilia Aryeetey, Ivy Amankwah, Emmanuella Abassah-Konadu, Godwin Gulbi, Saviour Yevutsey, Sergio Torres Rueda, Joseph Kazibwe, Francis Ruiz, Joycelyn Zeez, Justice Nonvignon
{"title":"Standards for the conduct and reporting of health technology assessments: Ghana reference case of HTA and economic evaluations.","authors":"Richmond Owusu, Brian Adu Asare, Genevieve Cecilia Aryeetey, Ivy Amankwah, Emmanuella Abassah-Konadu, Godwin Gulbi, Saviour Yevutsey, Sergio Torres Rueda, Joseph Kazibwe, Francis Ruiz, Joycelyn Zeez, Justice Nonvignon","doi":"10.1017/S026646232500011X","DOIUrl":"10.1017/S026646232500011X","url":null,"abstract":"<p><strong>Background: </strong>The methods of economic evaluation and HTA should be based on best practices and standards, tailored to unique country contexts that can be systematically applied to inform decisions. This paper outlines standards for the conduct of economic evaluations for HTA in Ghana.</p><p><strong>Methods: </strong>A five-step process was followed to develop the HTA reference case as a methodological and reporting benchmark. These include (a) a review of literature and evidence synthesis, (b) a review of country policies, (c) a review and adaption of international frameworks, (d) expert/stakeholder consultations, and (e) the development of a methodological framework. A series of stakeholder consultations were done to refine, finalize, and validate the outcomes of the processes to generate a finalized reference case.</p><p><strong>Results: </strong>The Ghana reference case is made up of 14 components comprising: evidence synthesis, evaluation type, perspectives on cost, perspectives of outcomes, choice of comparator, data sources, outcome measures, discount rate, uncertainty, equity considerations, time horizon, heterogeneity, transparency, and budget impact. These provide methodological considerations and reporting requirements for economic evaluations for HTA. It provides a framework to ensure the best research methods are adopted to harmonize the evidence-generation process with the expectations of policy and decision-makers and ensure that policy decisions are based on uniform evidence.</p><p><strong>Conclusion: </strong>Recommendations set out in this reference case when followed can provide context-specific evidence to support a rigorous and transparent system for evaluating healthcare interventions and technologies. It will support decision-making, ultimately improving the quality and efficiency of healthcare delivery in the country.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e17"},"PeriodicalIF":2.6,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536921","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}
P Lehoux, I Ganache, O Demers-Payette, H P Silva, G Plamondon, M de Guise
{"title":"HTA responsiveness to today's challenges to health systems: a responsible innovation in health perspective.","authors":"P Lehoux, I Ganache, O Demers-Payette, H P Silva, G Plamondon, M de Guise","doi":"10.1017/S0266462325000121","DOIUrl":"10.1017/S0266462325000121","url":null,"abstract":"<p><strong>Introduction: </strong>Though Health Technology Assessment (HTA) has steadily grown over the past decades, less attention has been paid to the way HTA may prove more responsive to the broader economic, social, and environmental challenges that health systems are facing today. In view of climate change, chronic diseases, an aging population, inequalities, and workforce issues, the HTA community's unique set of skills nonetheless holds great potential to help decision-makers strengthen many publicly funded health systems around the world.</p><p><strong>Methods: </strong>This article adopts an integrated system-wide perspective guided by the Responsible Innovation in Health (RIH) framework to explore how the HTA community may not only adapt to the <i>speed</i> of innovation but also consider its direction.</p><p><strong>Results: </strong>Because RIH aims to steer innovation toward a more sustainable pathway, it can help HTA agencies anticipate decision-makers' informational needs regarding four systemic challenges: (1) equitable access; (2) workforce issues; (3) accountable policy trade-offs; and (4) environmental sustainability. We clarify how key elements of the RIH framework may be used by HTA agencies to: (1) supplement their evaluation process; (2) align their priority-setting or strategic planning activities with their health system challenges; or (3) inform the production of early HTAs, horizon scans, or reports that are broader in scope than a single technology review.</p><p><strong>Conclusions: </strong>The article concludes with three practical implications that were identified by the <i>Institut National d'Excellence en Santé et Services Sociaux</i> (INESSS) (Québec, Canada) and may inspire other HTA agencies.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e16"},"PeriodicalIF":2.6,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11936730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536746","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}