Global & Regional Health Technology Assessment最新文献

{"title":"Determining value and the contribution of ciclosporin-based therapies in dry eye disease: a European expert MCDA pilot study.","authors":"Sajjad Ahmad, Francisco Figueiredo, Marc Labetoulle, Elisabeth M Messmer, Stefan Schrader, Philipp Steven, José M Benítez-Del-Castillo","doi":"10.33393/grhta.2026.3766","DOIUrl":"https://doi.org/10.33393/grhta.2026.3766","url":null,"abstract":"<p><strong>Introduction: </strong>Dry eye disease (DED) is a multifactorial, immune-mediated inflammatory condition affecting the ocular surface and lacrimal glands. Multiple ciclosporin-based therapies with different formulations are currently available in Europe, although clear guidance on their optimal use remains limited. The aim of this study was to determine the main unmet needs and the current management landscape of ciclosporin-based therapies, from the perspective of clinical experts using multi-criteria decision analysis (MCDA).</p><p><strong>Methods: </strong>A systematic literature review was conducted to gather evidence for each of the MCDA framework criteria. An international expert panel of seven clinical specialists in DED from four European countries independently weighted the criteria and scored the non-comparative criteria in the evidence matrix. Results were presented and discussed in a group online session.</p><p><strong>Results: </strong>DED is a highly prevalent, chronic inflammatory disease associated with significant visual and functional burden. Its management is not uniform and often involves a stepwise approach. Recent ciclosporin-based treatment alternatives address some unmet needs; however, others-such as the need for greater standardization of diagnostic tools and improved objective markers of inflammation-remain to be addressed. Highest importance was assigned to Efficacy/effectiveness (4.7 ± 0.5), Quality of evidence (4.7 ± 0.5), and Safety/tolerability (4.6 ± 0.5) criteria, highlighting the relevance of treatment-related outcomes in clinical decision-making.</p><p><strong>Conclusions: </strong>The expert opinion, based on MCDA, enabled the identification of key value drivers and unmet needs in the current management of DED based on ciclosporin-based therapies. These early insights may contribute to promoting future work to support informed, evidence-based decision-making.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"260-268"},"PeriodicalIF":0.7,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13662475/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149192607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Valutazione clinico-economica di strategie integrate per la gestione dell’asma grave in Italia: un approccio predittivo multidimensionale.","authors":"Filippo Rumi, Debora Antonini, Matteo Bonini, Giorgio Walter Canonica","doi":"10.33393/grhta.2026.3785","DOIUrl":"https://doi.org/10.33393/grhta.2026.3785","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"249-259"},"PeriodicalIF":0.7,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13664634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149192680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Budget impact della MhZT per il cateterismo intermittente in persone con sclerosi multipla o lesione midollare in Italia.","authors":"Agostino Fortunato, Filippo Rumi, Debora Antonini, Michele Basile, Elena Maria Calosci, Floriana D'Ambrosio, Eugenio Di Brino, Alessandra Fiore, Ciro Pappalardo, Roberto Ricciardi, Anna Scardigno, Ilaria Sciomenta, Giovanna Elisa Calabrò","doi":"10.33393/grhta.2026.3943","DOIUrl":"10.33393/grhta.2026.3943","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"241-248"},"PeriodicalIF":0.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13646820/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world application of an integrated MCDA-economic framework in continence care technology: a hospital-based case study.","authors":"Gianpaolo Franzoso, Novella Piazzetta, Giorgia Zorzetto, Mirsad Pasalic, Valentina Ceron, Flavia Damiano, Cristina Tridello, Marina Coppola","doi":"10.33393/grhta.2026.3828","DOIUrl":"10.33393/grhta.2026.3828","url":null,"abstract":"<p><strong>Introduction: </strong>Hospital-based Health Technology Assessment (HTA) supports transparent decisions about adopting medical technologies by balancing practical benefits against clinical, organizational, and economic consequences. This study evaluated a single-use continence care system using an integrated decision-support framework.</p><p><strong>Methods: </strong>The single-use system, based on disposable absorbent components, was compared with the standard reusable bedpan/urinal pathway, including washing and reprocessing. The assessment combined Multi-Criteria Decision Analysis (MCDA), Budget Impact Analysis (BIA), Cost-Consequence Analysis (CCA), a 30-day field test across inpatient units at two hospital sites, and an implementation-specific questionnaire. During the field test, 168 admissions were recorded. MCDA used a weighted aggregate score, while the economic analysis adopted the hospital perspective over three years. Deterministic sensitivity analyses examined economic inputs and MCDA domain weights.</p><p><strong>Results: </strong>The single-use system offered perceived advantages in ease of use, hygiene, and odor reduction. However, these did not offset limited supporting evidence, lower patient-comfort ratings, operational issues, and higher costs. The MCDA score decreased from 4.80 for standard care to 2.60 for the single-use system (difference: -2.20). Cost per patient increased from €0.65 to €1.00, an incremental cost of €0.35. The three-year budget impact was €2,634 and remained within the local affordability threshold. As the technology was more costly and produced lower overall MCDA value, it was classified as dominated. Sensitivity analyses did not alter the recommendation.</p><p><strong>Conclusion: </strong>The integrated MCDA-economic framework supported transparent hospital-level decision-making. Affordability and perceived practical advantages were insufficient to justify routine adoption of the single-use continence care system.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"230-240"},"PeriodicalIF":0.7,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13643327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149136228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the current and future role of artificial intelligence in pharmaceutical market access: insights from a European survey.","authors":"Stefania Brancone, Claudia Passante, Mariangela Prada","doi":"10.33393/grhta.2026.3813","DOIUrl":"10.33393/grhta.2026.3813","url":null,"abstract":"<p><strong>Introduction: </strong>Artificial Intelligence (AI) is rapidly expanding across the pharmaceutical value chain; however, empirical evidence on its application in Market Access (MA) remains limited. Given the strategic relevance and regulatory complexity of MA, understanding current AI adoption and perception represents a significant evidence gap. This study provides one of the first exploratory, European-focused assessments specifically investigating the role of AI in pharmaceutical MA.</p><p><strong>Methods: </strong>A structured, closed survey was conducted among European pharmaceutical MA executives and senior leaders. The questionnaire investigated AI adoption levels, governance and implementation models, perceived benefits and barriers, and current and future applications, with a focus on MA activities. The survey was distributed between June and November 2025 through targeted professional outreach and conference-based data collection.</p><p><strong>Results: </strong>Fifty responses were collected. Overall, 44% of respondents reported structural AI implementation within their organizations, with MA being the most impacted function (59%), contrasting with previous analyses where MA was among the least affected areas. AI adoption was strongly linked to company size, favoring large companies. Key barriers to AI adoption in MA included limited availability of high-quality data, data integration challenges, lack of internal expertise, and regulatory uncertainty. Reported benefits were mainly operational, while respondents identified strong future potential in market analysis, forecasting, health economics and outcomes research, and pricing and reimbursement strategy.</p><p><strong>Conclusions: </strong>AI is increasingly perceived as a valuable enabler in MA, although adoption remains heterogeneous and at an intermediate maturity stage. Effective integration requires robust governance, regulatory clarity, and AI-generated insights that support-rather than replace-human expertise.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"221-229"},"PeriodicalIF":0.7,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13596239/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149024607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impatto economico e organizzativo dell’implementazione di Peristeen Plus nella gestione della disfunzione intestinale neurogena: evidenze dall’Italia.","authors":"Filippo Rumi, Agostino Fortunato, Michele Basile, Eugenio Di Brino, Debora Antonini, Pier Raffaele Spena, Vincenzo Falabella","doi":"10.33393/grhta.2026.3729","DOIUrl":"10.33393/grhta.2026.3729","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"211-220"},"PeriodicalIF":0.7,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating MCDA and economic evaluation into a rule-based framework for hospital-level health technology assessment.","authors":"Gianpaolo Franzoso, Novella Piazzetta, Flavio Cazzador, Giorgia Zorzetto, Patrizia Simionato, Marina Coppola","doi":"10.33393/grhta.2026.3811","DOIUrl":"10.33393/grhta.2026.3811","url":null,"abstract":"<p><strong>Introduction: </strong>Health Technology Assessment (HTA) supports evidence-based decision-making, but integrating economic evaluation within Multi-Criteria Decision Analysis (MCDA) remains challenging in hospital-level HTA. This study developed and preliminarily applied an integrated decision-support framework combining MCDA, economic evaluation, and contextualized evidence assessment to support adoption recommendations.</p><p><strong>Methods: </strong>A pragmatic digital framework integrated MCDA with Budget Impact Analysis (BIA) and Cost-Consequence Analysis (CCA) within a rule-based decision matrix. The economic module estimated cost per patient, incremental cost, budget impact, cost-consequence outputs, and, when appropriate, a supportive soft ICER. Evidence was assessed through structured critical appraisal, Summary of Findings tables, and outcome relevance, using a GRADE-informed approach mapped onto the predefined 0-1-3-5-7-9 MCDA evidence scale. Operational robustness was assessed through Failure Mode and Effects Analysis (FMEA) and self-audit controls.</p><p><strong>Results: </strong>In a case study comparing disposable and reusable continence care systems, the disposable option showed a lower MCDA score than the current standard (2.60 vs 4.80; ΔMCDA = -2.20) and a higher cost per patient (€1.00 vs €0.65; incremental cost €0.35). Although the 3-year budget impact was €2,634 and remained within the institutional affordability threshold, the technology was classified as dominated because it generated lower value at a higher cost. The final recommendation was not favorable for routine adoption.</p><p><strong>Conclusion: </strong>The framework supports transparent integration of MCDA and economic evaluation in hospital-level HTA and helps distinguish affordability from overall value. The case study suggests that technologies should not be adopted solely because their budget impact is acceptable when the value-risk profile is unfavorable. Further validation across technologies and settings is required.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"201-210"},"PeriodicalIF":0.7,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13409110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148619720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Burden of primary biliary cholangitis on the Italian National Health Service: retrospective analysis from an administrative database.","authors":"Giulia Ronconi, Letizia Dondi, Nicola Ambrosio, Silvia Calabria, Gioele Maverna, Valentina Acciai, Valentina Buttiglione, Pietro Invernizzi, Marco Carbone, Alessio Gerussi, Umberto Vespasiani-Gentilucci, Nello Martini, Carlo Piccinni","doi":"10.33393/grhta.2026.3767","DOIUrl":"10.33393/grhta.2026.3767","url":null,"abstract":"<p><strong>Introduction: </strong>Primary biliary cholangitis (PBC) is a rare, chronic, cholestatic, autoimmune, and disabling liver disease whose treatments are aimed at reducing its progression.The aim was to describe patients with PBC, their healthcare resource utilization (HCRU) and costs on the Italian National Health Service (SSN).</p><p><strong>Methods: </strong>From an Italian administrative healthcare database (~5.5 million inhabitants), called ReS Db, patients with PBC in 2021 (prevalent) were selected by specific codes and described by demographics, comorbidities, one-year HCRU, and health sector costs charged to the SSN. The 3-year treatment pattern was evaluated in a cohort of patients newly diagnosed in 2019 (incident).</p><p><strong>Results: </strong>In 2021, 1375 patients with PBC were identified (prevalence: 28.2/100,000; females: 74.2%; mean age: 64 ± 15 years). During one-year follow-up of the prevalent cohort: 73.1% received ursodeoxycholic acid (UDCA); 3.0% obeticholic acid (OCA), and 3.4% off-label drugs; 19.9% were hospitalized, mainly for cirrhosis-related conditions; 61.2% were examined by a specialist. The annual mean cost was €4422/patient; drugs for PBC, concomitant drugs, and hospitalizations accounted for 12.1%, 31.7%, and 43.6% of total cost, respectively. Among the 40 incident patients, 38 (95%) received UDCA as first-line therapy.</p><p><strong>Conclusion: </strong>The study described the real-world impact of PBC in Italy from the perspective of the SSN and highlighted the burden and therapeutic needs of patients treated with UDCA.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"192-200"},"PeriodicalIF":0.7,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13390707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148561685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacoeconomic analysis of switch to faricimab for neovascular age-related macular degeneration in real clinical practice.","authors":"Jorge Ruiz-Medrano, Mariluz Puertas, María Hinojosa-Gonzalez, Carlota Moreno-Alboran, José Ma Ruiz-Moreno","doi":"10.33393/grhta.2026.3800","DOIUrl":"10.33393/grhta.2026.3800","url":null,"abstract":"<p><strong>Introduction: </strong>Neovascular age-related macular degeneration (nAMD) is one of the leading causes of severe vision loss among older adults. This condition impairs patients' quality of life and imposes a significant economic burden on the healthcare system. This study aims to determine the difference in direct healthcare cost (DHC) after switching the current pharmacological treatment in patients with nAMD, under a treat-and-extend regimen, to faricimab.</p><p><strong>Methods: </strong>Treatment interval data obtained after switching to faricimab in 225 eyes with nAMD was used to calculate total DHC in comparison with the theoretical DHC had if patients remained on their previous treatment (drug and treatment interval). An \"optimal responder\" was defined as a patient whose interval between intravital injections was extended by more than 8 weeks relative to the baseline treatment interval.</p><p><strong>Results: </strong>The theoretical DHC of treatment for this series of nAMD eyes would have been €2,351,241.90, compared with an actual DHC after switching to faricimab of €1,718,015.83, representing a saving of €633,226.06 for 225 eyes. The mean theoretical DHC would have been €10,449.96 ± 4,340.18 (from 1,423.75 to 23,695.20), compared with a mean actual total cost of €7,635.62 ± 2,465.07 (from 2,571.88 to 15,431.28). The mean actual DHC was €8,499.74 ± 2,678.42 in the \"non-optimal responder\" group versus €6,593.59 ± 1,674.91 in the \"optimal responder\" group (p < 0.001).</p><p><strong>Conclusion: </strong>Switching to faricimab in patients with nAMD on a treat-and-extend regimen with a treatment interval of less than 12 weeks resulted in a significant reduction in total DHC, particularly in the \"optimal responder\" group.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"185-191"},"PeriodicalIF":0.7,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13353031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148420642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comments on: Use of artificial intelligence to draft a mini-HTA report on a new medical device belonging to class IIb-III.","authors":"Erminia Caccese, Ramona Giardino, Maria Gabriella Paolì, Andrea Messori, Fabio Lena","doi":"10.33393/grhta.2026.3937","DOIUrl":"10.33393/grhta.2026.3937","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"184"},"PeriodicalIF":0.7,"publicationDate":"2026-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13348239/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148420606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}