Global & Regional Health Technology Assessment最新文献

{"title":"Dal quadro normativo alla pratica: il regolamento UE HTA 2021/2282, il ruolo dell'AIFA e le interazioni con gli sviluppatori: processi, interfacce, aspettative.","authors":"Patrizia Popoli, Walter Marrocco, Anna Ponzianelli, Francesco Damele, Massimo Medaglia","doi":"10.33393/grhta.2025.3599","DOIUrl":"https://doi.org/10.33393/grhta.2025.3599","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"245-248"},"PeriodicalIF":0.5,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12617357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145540254","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":"Patient and public involvement in health technology assessment committees: who is free from conflicts of interest?","authors":"Gustavo H Marin, Santiago Hasdeu","doi":"10.33393/grhta.2025.3623","DOIUrl":"10.33393/grhta.2025.3623","url":null,"abstract":"<p><p>Scientific and technological advances have increased the capacity to prevent diseases, perform diagnoses, and develop innovative treatments. To analyze whether these technologies should be incorporated into healthcare systems, Health Technology Assessment (HTA) Committees were created. There is a debate about who should be part of such committees. Typically, committee members are scientific experts, agents of funding entities (Ministries of Health), and patients as representatives of the community. It is important to reflect on the conflicts of interest that each member may have. Those who come from the scientific sector (universities, research centers) have fewer conflicts of interest and more independence for decision-making. The agents designated as members by the Ministries of Health of each country are usually qualified professionals, but still employees of those who will later have to pay for the technology. The third type of members are patients representing the community. This participation is considered a guarantee of neutrality, however, since patients are affected by the same health problem that is being analyzed, it exists a personal interest in expecting that a new medicine could be accepted to benefit other patients with the same condition (horizontal equity); with a potential risk of not showing the same empathy in recognizing the impact of this decision on other health problems (vertical equity). This text discusses the composition of HTA Committees, the conflicts of interest of its members, and the potential impact of these decisions on equity in access to the population to essential goods.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"242-244"},"PeriodicalIF":0.5,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12559928/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145400440","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":"Stima dei pazienti potenzialmente eleggibili alla terapia con icosapent etile in Italia mediante revisione dei dati di letteratura.","authors":"Pasquale Perrone Filardi, Emanuela Arcangeli, Pierluigi Carullo, Carlotta Galeone, Marcello Arca","doi":"10.33393/grhta.2025.3503","DOIUrl":"10.33393/grhta.2025.3503","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"234-241"},"PeriodicalIF":0.5,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12529072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145328930","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":"Optimising pediatric paracetamol and ibuprofen use: a retrospective study with expert evaluation of efficacy, safety, and healthcare costs.","authors":"Andrea Marcellusi, Angela Ragonese, Antonio D'Avino, Maurizio Taglialatela, Andrea Lo Vecchio","doi":"10.33393/grhta.2025.3579","DOIUrl":"10.33393/grhta.2025.3579","url":null,"abstract":"<p><strong>Background: </strong>Paracetamol and ibuprofen are widely used for fever and pain in children, but real-world prescribing often deviates from guidelines, leading to potentially avoidable complications and healthcare costs.</p><p><strong>Objectives: </strong>To estimate the clinical and economic burden associated with inappropriate use of paracetamol and ibuprofen in Italian pediatric care and to identify high-risk clinical scenarios in which safer prescribing may reduce complications.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on national hospital discharge records (2010-2016), focusing on DRGs and ICD-9-CM codes linked to adverse events following antipyretic or NSAID use in children aged 0-17. A qualitative assessment was also carried out through expert consultation to contextualize findings.</p><p><strong>Results: </strong>Among 999,739 hospital discharges, 4,308 cases (0.43%) developed complications within three years. ENT procedures and renal diagnoses showed the highest complication rates and costs. Children under three accounted for the largest share of healthcare expenditure. A scenario analysis using pneumonia data suggested that up to 3,000 complications and €10 million in costs could be avoided with more selective NSAID use. Experts recommended prioritizing paracetamol in high-risk scenarios, including dehydration, respiratory infections, and varicella.</p><p><strong>Conclusions: </strong>Inappropriate use of antipyretics in pediatric care is associated with a measurable clinical and financial burden. Greater adherence to prescribing recommendations, especially in vulnerable populations, can improve outcomes and reduce costs. Educating caregivers and harmonizing clinical practices are key priorities.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"227-233"},"PeriodicalIF":0.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12504983/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145258153","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":"Conseguenze economiche dell’introduzione del dispositivo JADA® come trattamento alternativo per la gestione dell’emorragia postpartum in Italia.","authors":"Andrea Marcellusi, Giulio Guarnotta, Carlo Tomino","doi":"10.33393/grhta.2025.3446","DOIUrl":"10.33393/grhta.2025.3446","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"218-226"},"PeriodicalIF":0.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12503120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250871","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":"I tetti sulla spesa per i farmaci nel quadro delle azioni di governo dell’assistenza farmaceutica: criticità e opzioni per una riforma.","authors":"Claudio Jommi","doi":"10.33393/grhta.2025.3622","DOIUrl":"10.33393/grhta.2025.3622","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"214-217"},"PeriodicalIF":0.5,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145199066","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 impact of multimorbidity in Italy: evaluation of direct costs and scenario analysis of patients with type 2 diabetes, heart failure, and chronic kidney disease using real-world data.","authors":"Valentina Perrone, Claudio Ripellino, Maria Cappuccilli, Melania Leogrande, Andrea Cinti Luciani, Luca Degli Esposti","doi":"10.33393/grhta.2025.3509","DOIUrl":"10.33393/grhta.2025.3509","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the healthcare costs associated with managing type 2 diabetes (T2D), chronic kidney disease (CKD), and heart failure (HF) in Italy. Specifically, the research investigated the economic impact on the Italian National Health System due to the increased clinical complexity and multimorbidity among patients with these conditions.</p><p><strong>Methods: </strong>A predictive model was developed to estimate the costs of managing patients with T2D, CKD, and HF, either as standalone diseases or in combination. Epidemiological data were derived from real-world data, analyzing a sample corresponding to approximately 10% of the Italian population. The model stratified patients into seven groups based on disease combinations and estimated direct healthcare costs, resulting from hospitalizations, medications, and outpatient services. Scenario analyses were performed to forecast costs based on the expected progression of single diseases to multimorbid conditions.</p><p><strong>Results: </strong>The analysis estimated a total annual healthcare expenditure of approximately €18.7 billion for the 5.77 million Italian patients with at least one of these diseases. Patients with T2D, CKD, and HF had an average yearly cost of €2,002, €4,322, and €5,061, respectively, with multimorbid patients incurring significantly higher costs. Scenario analyses predicted a potential increase in total healthcare expenditures to €19.5 billion, with an additional burden of €775 million.</p><p><strong>Conclusions: </strong>The findings underscore the substantial economic burden of T2D, CKD, and HF, exacerbated by multimorbidity. The results highlight the need for early diagnosis, targeted prevention, and optimized treatment strategies to mitigate rising healthcare costs and improve patients' outcomes.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"205-213"},"PeriodicalIF":0.5,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12457957/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148900","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":"RWE in oncologia: uso dei database per identificare i sottotipi molecolari del cancro mammario metastatico in Italia.","authors":"Valentina Perrone, Maria Cappuccilli, Melania Leogrande, Stefania Saragoni, Andrea Cinti Luciani, Sandro Barni, Luca Degli Esposti","doi":"10.33393/grhta.2025.3568","DOIUrl":"10.33393/grhta.2025.3568","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"198-204"},"PeriodicalIF":0.5,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12412310/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014959","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":"Paving the road for a successful EU HTA Reform implementation.","authors":"Hans Severens, Andrew Dillon, Francois Meyer, Claudio Jommi, Lipska Iga, Pier Luigi Canonico, Oriol Solà-Morales, Herbert Altman","doi":"10.33393/grhta.2025.3502","DOIUrl":"10.33393/grhta.2025.3502","url":null,"abstract":"<p><p>The article explores the challenges and opportunities presented by the implementation of the EU Health Technology Assessment Regulation (EU HTAR). It highlights the varying degrees of readiness among Member States (MSs) and the perceived concerns regarding loss of sovereignty. The discussion emphasizes the importance of national preparedness, reducing bureaucratic inefficiencies, and fostering transparent communication among stakeholders. The article also underlines the critical role of Joint Scientific Consultation (JSC) in optimizing regulatory and HTA processes, advocating for an expansion of JSC slots and selection criteria. Moreover, it calls for greater involvement of clinicians and patient advocacy organizations to enhance trust and facilitate effective implementation. Ultimately, the article argues that strengthening collaboration, optimizing regulatory pathways, and ensuring comprehensive stakeholder engagement are key to realizing the full potential of the EU HTAR and improving patient access to innovative medicines across Europe.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"194-197"},"PeriodicalIF":0.5,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12396001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144950915","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":"Micro-costing analysis from Italian Guidelines for the management of sporadic primary hyperparathyroidism.","authors":"Valentini Ilaria, Michele Basile, Fabio Vescini, Giorgio Borretta, Iacopo Chiodini, Marco Boniardi, Marina Carotti, Elena Castellano, Cristiana Cipriani, Cristina Eller-Vainicher, Sandro Giannini, Maurizio Iacobone, Antonio Stefano Salcuni, Federica Saponaro, Stefano Spiezia, Annibale Versari, Guido Zavatta, Zuzana Mitrova, Rosella Saulle, Alexia Giovanazzi, Roberto Novizio, Agostino Paoletta, Enrico Papini, Agnese Persichetti, Irene Samperi, Alessandro Scoppola, Pietro Giorgio Calò, Filomena Cetani, Luisella Cianferotti, Sabrina Corbetta, Maria Luisa De Rimini, Alberto Falchetti, Stefano Laureti, Celestino Pio Lombardi, Bruno Madeo, Claudio Marcocci, Sandro Mazzaferro, Vittorio Miele, Salvatore Minisola, Andrea Palermo, Jessica Pepe, Alfredo Scillitani, Franco Grimaldi, Renato Cozzi, Roberto Attanasio","doi":"10.33393/grhta.2025.3531","DOIUrl":"10.33393/grhta.2025.3531","url":null,"abstract":"<p><strong>Introduction: </strong>Primary hyperparathyroidism (PHPT) is a common endocrine disorder, primarily caused by single adenomas or multiglandular disease. This study evaluates the economic impact of different PHPT treatment approaches from both the Italian National Health Service and societal perspectives.</p><p><strong>Methods: </strong>A micro-costing approach was used to estimate the costs of surgical and non-surgical treatments. Data were gathered through a survey among panel members responsible for the Italian PHPT treatment guidelines, ensuring alignment with national clinical practice. The survey examined various cost components, including diagnostic tests, pre-hospitalization assessments, surgery duration, drug use, healthcare professionals involved, disposable materials, and follow-up care requirements.</p><p><strong>Results: </strong>The total cost for PHPT diagnosis and comorbidity assessment is € 887.96. Parathyroidectomy (PTX) costs € 4,588.00. Non-surgical alternatives, including pharmacological treatment (€ 953.34 annually) and active surveillance (€ 197.42 annually), result in cumulative 30-year costs of € 28,590 and € 5,910, respectively. Since PTX is typically performed at age 55, pharmacological treatment over 30 years incurs an additional € 22,876 per patient compared to surgery.</p><p><strong>Conclusions: </strong>Despite its higher upfront cost, PTX demonstrated long-term cost efficiency due to the relatively low rates of follow-up complications and the absence of recurring annual costs associated with conservative strategies.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"12 ","pages":"186-193"},"PeriodicalIF":0.5,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12292212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144729706","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}