Global & Regional Health Technology Assessment最新文献

{"title":"Cost of illness of Heart Valve Diseases (HVDs): A real-world analysis in Italy.","authors":"Paolo Sciattella, Matteo Scortichini","doi":"10.33393/grhta.2025.3243","DOIUrl":"https://doi.org/10.33393/grhta.2025.3243","url":null,"abstract":"<p><strong>Introduction: </strong>Heart valve diseases constitute a significant public health challenge with substantial clinical and economic implications. The ageing population, coupled with advancements in surgical techniques, has led to increased hospitalizations for cardiac valve interventions over the past decade. Despite progress, the economic burden of heart valve diseases remains underexplored, particularly in the context of the Italian healthcare system. This study aims to comprehensively assess the economic burden of heart valve diseases in Italy through a real-world analysis.</p><p><strong>Methods: </strong>Using data from the national Italian Hospital Discharge Records (SDO), we identified the number of adult patients undergoing interventions on the aortic, mitral, and tricuspid valves, along with the associated costs borne by the National Health System. Additionally, we estimated indirect costs by analyzing social security benefit applications related to valve diseases from 2016 to 2019.</p><p><strong>Results: </strong>A notable rise in hospitalizations for cardiac valve interventions, particularly for the aortic (+53.3%) and mitral valves (+29.5%) was revealed through the study period. In-hospital mortality rates declined, reflecting advancements in perioperative care. The economic burden of heart valve diseases in Italy was substantial, with hospitalization costs reaching €808 million in 2018. Social security benefit applications also increased, adding an annual cost of €29 million.</p><p><strong>Conclusions: </strong>Heart valve diseases represent a growing clinical and socio-economic challenge in Italy. This study underscores the imperative for a multidisciplinary approach to effectively manage these conditions. Emphasizing prevention, early diagnosis, and timely interventions is crucial to mitigate the economic impact and enhance the quality of life for patients.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"34-42"},"PeriodicalIF":0.4,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491664","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":"Verso un Green Health Technology Assessment: il ruolo del Life Cycle Assessment per scelte sanitarie più sostenibili.","authors":"Michela Bobini, Eugenio Di Brino, Americo Cicchetti","doi":"10.33393/grhta.2025.3399","DOIUrl":"10.33393/grhta.2025.3399","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"29-33"},"PeriodicalIF":0.4,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11836658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457680","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":"Economic and clinical burden associated with respiratory syncytial virus and impact of universal immunization with nirsevimab in Italy.","authors":"Andrea Marcellusi, Chiara Bini, Barbara Muzii, Samira Soudani, Alexia Kieffer, Matthieu Beuvelet, Elena Bozzola, Fabio Midulla, Eugenio Baraldi, Paolo Bonanni, Sara Boccalini, Luigi Orfeo","doi":"10.33393/grhta.2025.3182","DOIUrl":"10.33393/grhta.2025.3182","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the seasonal respiratory syncytial virus (RSV) burden in Italy considering the current prophylaxis strategy with palivizumab recommended only for high-risk infants (representing only 4.4% of an estimated birth cohort) and to evaluate the potential benefits of a new prophylaxis strategy targeting all infants with nirsevimab.</p><p><strong>Methods: </strong>A static decision analytic model previously used in the US was adapted to evaluate the RSV-related health and cost outcomes associated with nirsevimab versus standard of care (SoC) for the prevention of RSV medically attended lower respiratory tract infections (RSV-MA-LRTIs). Monthly probabilities of RSV infections, health events, mortality, and complications associated with RSV infections were obtained from the literature. Costs associated with each event were obtained using the available literature and through real-world data analysis of National Hospital Discharge Records.</p><p><strong>Results: </strong>For one RSV season, in the current SoC, the model estimated 216,100 RSV-MA-LRTIs, 15,121 associated complications, and 16 RSV-deaths-corresponding to an economic burden of approximately €50.5 million related to RSV-MA-LRTIs management, €10.9 million associated with potential complications due to RSV and €3 million in lost productivity due to RSV-deaths. Nirsevimab is expected to prevent 100,208 RSV-MA-LRTIs, 6,969 complications, and 6 deaths due to RSV infections, corresponding to an economic saving of about €23.3, €5, and €1.2 million, respectively.</p><p><strong>Conclusion: </strong>Nirsevimab is a new prophylaxis strategy that helps to protect all infants against RSV disease and could substantially reduce the clinical and economic burden of RSV in Italy in infants experiencing their first RSV season.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"16-28"},"PeriodicalIF":0.4,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143079352","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":"Value contribution of leniolisib in the Treatment of Activated PI3Kδ syndrome (APDS) in Spain using Multi-Criteria Decision Analysis (MCDA).","authors":"María Reyes Abad, Carmen Alerany, Luis Ignacio González, Olaf Neth, Concepción Payares-Herrera, Carlos Rodríguez-Gallego, Jose Luis Trillo, Kirsten H Herrmann, Raquel Figueiredo, Alicia Gil","doi":"10.33393/grhta.2025.3199","DOIUrl":"https://doi.org/10.33393/grhta.2025.3199","url":null,"abstract":"<p><strong>Background: </strong>Activated phosphoinositide 3-kinase (PI3K) δ Syndrome (APDS) is an ultra-rare, potentially life-threatening disease that lacks approved treatments in Spain. This study aimed to apply Multi-Criteria Decision Analysis (MCDA) to assess the value of the first pharmacological treatment for APDS in Spain.</p><p><strong>Methods: </strong>A multidisciplinary group of 8 experts evaluated the selective PI3Kδ inhibitor leniolisib against Standard of Care (SoC). An MCDA framework tailored for Orphan Drugs (ODs), consisting of 5 comparative and 2 quantitative non-comparative criteria, was used. Re-scoring followed a group discussion.</p><p><strong>Results: </strong>Leniolisib scored higher than SoC in all criteria, including efficacy and safety. It was deemed highly valuable as the first disease-modifying treatment, with a positive therapeutic impact and potential to improve patients' quality of life. Additionally, leniolisib may lead to cost savings. The supporting data was considered of high quality.</p><p><strong>Conclusion: </strong>Based on MCDA methodology and stakeholder experience in APDS management, leniolisib is seen as a value-added treatment option compared to SoC in Spain.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"9-15"},"PeriodicalIF":0.4,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064784","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":"What is needed to successfully implement the EU HTA Regulation enabling broad patient access in Europe.","authors":"Iga Lipska, Francois Meyer, Pier-Luigi Canonico, Herbert Altman, Oriol Solà-Morales","doi":"10.33393/grhta.2025.3354","DOIUrl":"https://doi.org/10.33393/grhta.2025.3354","url":null,"abstract":"<p><p>There has been a lot of discussion on the technical aspects of the soon to be implemented European Union's Health Technology Assessment (EU HTA) regulation. However, there has been limited discussion on the implementation aspects and the potential limitations from a policy perspective. In May 2024, a group of HTA experts with previous policy responsibilities met in Rome to propose some policy aspects to be considered. As a result of the discussion, several proposals were made. Building mutual trust, improving collaboration and engaging all relevant stakeholders seems a must. Equally important are the communication aspects, and ensuring equal commitment by all parties, allocating the appropriate incentives at all levels. Finally, it is noted that the EU HTA regulation has to be seen from the perspective of a wider policy change within the large EU legal framework.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"7-8"},"PeriodicalIF":0.4,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744311/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004215","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":"La durata delle procedure di negoziazione di prezzo e rimborso in Italia nel periodo 2021-2023 è stata indipendente dal prezzo dei medicinali.","authors":"Raffaella Cocciolo, Paola Turella, Daniela Pilunni, Pierluigi Navarra","doi":"10.33393/grhta.2025.3259","DOIUrl":"https://doi.org/10.33393/grhta.2025.3259","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"1-6"},"PeriodicalIF":0.4,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11736643/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004212","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":"The economic burden of post-endoscopic retrograde cholangiopancreatography (ERCP) procedure infections in Italy.","authors":"Paolo Sciattella, Annarosa Fornero, Susanna M A Giordano, Claudio G De Angelis, Francesco Cattel","doi":"10.33393/grhta.2024.3186","DOIUrl":"10.33393/grhta.2024.3186","url":null,"abstract":"<p><strong>Introduction: </strong>The infections of multidrug-resistant organisms (MDROs) associated with duodenoscopes during endoscopic retrograde cholangiopancreatography (ERCP) procedure have become a significant cause for concern, especially in fragile patients. While the clinical impacts of these infections are well-documented, their economic implications remain underexplored. This study assesses the incidence and economic burden of post-ERCP infections in Italy using an administrative database.</p><p><strong>Methods: </strong>We conducted a retrospective observational study using administrative databases from A.O.U. Città della Salute e della Scienza di Torino. The study included all patients who underwent their first inpatient ERCP between 2018 and 2021. Infections were identified using ICD-9-CM codes for <i>Pseudomonas aeruginosa</i>, <i>Clostridium difficile</i>, <i>Escherichia coli</i>, <i>Klebsiella</i> spp., and <i>Staphylococcus aureus</i>. A 1-year follow-up was defined in order to estimate healthcare resource utilization and related costs, including readmissions, drug prescriptions, and outpatient specialist and laboratory services.</p><p><strong>Results: </strong>The study included 686 inpatient ERCP cases, an overall infection rate of 4.2% was observed. Higher infection rates were observed in women (4.6%), patients over 70 years old (4.6%), emergency admissions (5.1%), and transplant patients (19.1%). The average hospital stay doubled for infected patients (24.3 vs. 11.3 days; p=0.001). Post-ERCP infections led to a 28% increase in average costs (€12,256 vs. €9,561; p=0.048). With an annual volume of 25,000 ERCP procedures, post-ERCP infections in Italy contribute approximately €2.9 million in additional direct costs per year.</p><p><strong>Conclusion: </strong>Post-ERCP infections impose substantial financial burdens on the healthcare system, underscoring the critical importance of implementing cost-effective prevention strategies to mitigate this public health threat in Italy.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"258-264"},"PeriodicalIF":0.4,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11736644/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004211","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":"Analisi di costo-efficacia di brentuximab vedotin in combinazione con doxorubicina, vinblastina e dacarbazina (AVD) in pazienti adulti affetti da linfoma di Hodgkin in stadio IV.","authors":"Andrea Marcellusi, Chiara Bini, Francesco Saverio Mennini, Silvia Ripoli, Laura Fioravanti, Victoria Federico Paly, Alexa Lina Molinari, Paolo Morelli, Stanimira Krotneva, Shujun Li","doi":"10.33393/grhta.2024.3167","DOIUrl":"10.33393/grhta.2024.3167","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"248-257"},"PeriodicalIF":0.4,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11633240/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812873","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":"A 1-year per-patient cost of therapy administration analysis of mosunetuzumab and tisagenlecleucel in relapsed or refractory follicular lymphoma patients receiving two or more lines of systemic therapy.","authors":"Marco Bellone, Alice Sabinot, Alessandro D'Arpino, Emanuela Omodeo Salè, Daniela Ghislieri, Lorenzo Pradelli","doi":"10.33393/grhta.2024.3170","DOIUrl":"10.33393/grhta.2024.3170","url":null,"abstract":"<p><strong>Objective: </strong>A per-patient cost of therapy administration model was developed to estimate the cost of mosunetuzumab vs. tisagenlecleucel in patients with relapsing or refractory follicular lymphoma (R/R FL) receiving two or more lines of systemic therapy (3L+) from both the Italian hospital and societal perspectives.</p><p><strong>Methods: </strong>A per-patient total cost of therapy administration model was developed to compare the resource consumption of two treatments - mosunetuzumab and tisagenlecleucel. The model considered direct costs such as healthcare labor costs for drug preparation and administration, non-drug consumable costs, and drug purchase. Indirect costs such as patient and caregiver's loss of productivity, transportation, and relocation were also considered. The unit costs and resource use data were retrieved from literature and standard Italian tariffs. To appraise the impact of patients' residency on access-to-care and out-of-pocket expenses, three scenario analyses were conducted.</p><p><strong>Results: </strong>Over 1 year, mosunetuzumab costs approximately one-fourth of tisagenlecleucel per patient. The base-case scenario showed a hospital cost reduction of €158,870 per patient with mosunetuzumab, increasing to €161,974 when including societal costs. Scenario analyses for the societal perspective estimated cost differences of -€161,170, -€166,507, and -€166,811 for scenarios A, B, and C, respectively. Sensitivity analysis indicated that tisagenlecleucel's price had the greatest impact on cost differences, followed by mosunetuzumab's price.</p><p><strong>Conclusions: </strong>This analysis identifies mosunetuzumab as an accessible therapeutic option for 3L+ R/R FL patients in Italy. Future research should collect real-time data and evaluate long-term outcomes.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"239-247"},"PeriodicalIF":0.4,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806722","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 di dapagliflozin nella gestione della malattia renale cronica in Italia: risultati di un modello di micro-simulazione.","authors":"Roberto Ravasio, Andrea Marcellusi, Luca de Nicola","doi":"10.33393/grhta.2024.3309","DOIUrl":"10.33393/grhta.2024.3309","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"231-238"},"PeriodicalIF":0.4,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11615928/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142778970","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}