{"title":"Costo per <i>Number Needed to Treat</i> (NNT) di upadacitinib nel trattamento dei pazienti <i>bio-exposed</i> con rettocolite ulcerosa attiva da moderata a grave.","authors":"Flavio Caprioli, Massimo Claudio Fantini, Francesca Marando, Dario Scaduto, Roberto Ravasio","doi":"10.33393/grhta.2024.2658","DOIUrl":"10.33393/grhta.2024.2658","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"55-67"},"PeriodicalIF":0.5,"publicationDate":"2024-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10926000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140101425","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":"Regolamento HTA: come si sta muovendo l’Italia?","authors":"Francesca Patarnello","doi":"10.33393/grhta.2024.3025","DOIUrl":"https://doi.org/10.33393/grhta.2024.3025","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"51-54"},"PeriodicalIF":0.5,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10915632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140051473","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}
Andrea Chiricozzi, Antonio Costanzo, Anna Levi, Federica Parretta, Roberto Ravasio
{"title":"Costo per NNT di upadacitinib nel trattamento dei pazienti con dermatite atopica da moderata a severa in Italia.","authors":"Andrea Chiricozzi, Antonio Costanzo, Anna Levi, Federica Parretta, Roberto Ravasio","doi":"10.33393/grhta.2024.2728","DOIUrl":"10.33393/grhta.2024.2728","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"38-50"},"PeriodicalIF":0.5,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10877702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139912464","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}
Agostino Fortunato, Filippo Rumi, Massimo Zazzetta, Marco Della Valle, Vincenzo Pedace, Americo Cicchetti
{"title":"Il burden clinico ed economico delle complicanze della cute peristomale: un’analisi di Activity Based Costing.","authors":"Agostino Fortunato, Filippo Rumi, Massimo Zazzetta, Marco Della Valle, Vincenzo Pedace, Americo Cicchetti","doi":"10.33393/grhta.2024.2639","DOIUrl":"10.33393/grhta.2024.2639","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"31-37"},"PeriodicalIF":0.4,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10813189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139570373","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}
Massimo Medaglia, Giuliano Buzzetti, Marco Cossolo, Paola Deambrosis, Giovanna Scroccaro
{"title":"Il futuro delle forme di distribuzione dei farmaci in regime di Servizio Sanitario Nazionale.","authors":"Massimo Medaglia, Giuliano Buzzetti, Marco Cossolo, Paola Deambrosis, Giovanna Scroccaro","doi":"10.33393/grhta.2024.2619","DOIUrl":"https://doi.org/10.33393/grhta.2024.2619","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"17-21"},"PeriodicalIF":0.5,"publicationDate":"2024-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10792386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139484939","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}
Silvia Calabria, Lucio Manenti, Giulia Ronconi, Carlo Piccinni, Letizia Dondi, Leonardo Dondi, Antonella Pedrini, Immacolata Esposito, Alice Addesi, Filippo Aucella, Nello Martini
{"title":"Italian healthcare resource consumption for patients on hemodialysis treated for chronic kidney disease-associated pruritus (CKD-aP).","authors":"Silvia Calabria, Lucio Manenti, Giulia Ronconi, Carlo Piccinni, Letizia Dondi, Leonardo Dondi, Antonella Pedrini, Immacolata Esposito, Alice Addesi, Filippo Aucella, Nello Martini","doi":"10.33393/grhta.2024.2696","DOIUrl":"10.33393/grhta.2024.2696","url":null,"abstract":"<p><strong>Background: </strong>Chronic kidney disease-associated pruritus (CKD-aP) affects patients on hemodialysis. This study identified hemodialysis patients presumably affected or not affected by CKD-aP and integrated healthcare costs, from the perspective of the Italian administrative healthcare data.</p><p><strong>Methods: </strong>Through cross-linkage of Italian administrative healthcare data collected between 2015 and 2017 (accrual period) in the database of Fondazione ReS (Ricerca e Salute), patients undergoing in-hospital/outpatient hemodialysis were selected. Cohorts with and without CKD-aP were created based on the presence/absence of CKD-aP-related treatment (according to common clinical practice and guidelines) supplies and assessed in terms of CKD-aP-related treatments and mean healthcare costs per capita paid by the Italian National Health Service (INHS).</p><p><strong>Results: </strong>Of 1,239 people on hemodialysis for ≥2 years, CKD-aP affected 218 patients. Patients with CKD-aP were older and with more comorbidities. During the follow-up year, on average, the INHS spent €37,065 per case, €31,286 per control and € 35,988 per non-CKD-aP subject. High-efficiency dialytic therapies performed to people on hemodialysis with CKD-aP largely weighed on the overall mean annual cost.</p><p><strong>Conclusions: </strong>This real-world study identified patients on chronic hemodialysis potentially treated for CKD-aP. Interestingly, high-efficiency dialysis seems the most frequent and expensive choice for the treatment of CKD-aP. The discovery of appropriate and effective treatments for this condition might offer cost offsets.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"11 ","pages":"22-30"},"PeriodicalIF":0.5,"publicationDate":"2024-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10792387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139484946","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}
Maria Lucia Marino, Eva Alessi, Aurora Di Filippo, Barbara Polistena, Francesco Macchia, Federico Spandonaro, Francesco Trotta
{"title":"Farmaci orfani in Italia: disponibilità e tempi di accesso a livello regionale.","authors":"Maria Lucia Marino, Eva Alessi, Aurora Di Filippo, Barbara Polistena, Francesco Macchia, Federico Spandonaro, Francesco Trotta","doi":"10.33393/grhta.2023.2641","DOIUrl":"10.33393/grhta.2023.2641","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"89-97"},"PeriodicalIF":0.5,"publicationDate":"2023-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10757301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139073770","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}
Andrea Marcellusi, Paola Raimondo, Carlotta Galeone, Pier Luigi Canonico
{"title":"Time to market access in Italia: durata del processo di P&R per i farmaci per le malattie rare.","authors":"Andrea Marcellusi, Paola Raimondo, Carlotta Galeone, Pier Luigi Canonico","doi":"10.33393/grhta.2023.2610","DOIUrl":"10.33393/grhta.2023.2610","url":null,"abstract":"Time to market access in Italy: duration of the P&R process for rare disease drugs Objective: This paper aims to investigate the duration of the pricing & reimbursement (P&R) procedures submitted in Italy by pharmaceutical marketing authorization holders (MAH) for drugs indicated for rare diseases. Methods: All the data used in this analysis were publicly available on different sources of the Italian Ministry of Health, the Italian Medicines Agency (AIFA) and other official websites. The information was systematically collected to investigate the timeline (days) needed to complete the P&R process. The process was divided into 6 simplified steps and the median and range of days needed for each phase were estimated based on data reported in official/published documents. The analysis was stratified considering every single step of the assessment phase and included segmentation of drugs into indications for rare diseases, Orphan designation, Innovation assessment and Managed entry agreements (MEAs). Results: Overall, 181 first indication procedures were submitted to AIFA in the period considered and, of these, 167 (92.3%) were completed and 129 procedures were considered for the final analysis and the median duration of the entire process (MAH submission to final Gazette publication) was 434 days (range 176.0-918.0). The duration of procedures for rare diseases (n = 53) was longer than those for non-rare-disease procedures (n = 76) (463.0 days vs 407.5 days respectively). Among rare disease procedures, orphan designation and MEAs represent predictors for time prolongation while innovation is associated with a shorter assessment time. Conclusion: The study describes the time spent in each phase of the assessment and the appraisal process and demonstrates that uncertainty represents the main driver for the increment in the overall time.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"79-88"},"PeriodicalIF":0.5,"publicationDate":"2023-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71524075","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":"Il bisogno insoddisfatto: definizioni, evidenze di letteratura e implicazioni per l’HTA.","authors":"Claudio Jommi, Michela Meregaglia, Carmine Pinto","doi":"10.33393/grhta.2023.2624","DOIUrl":"10.33393/grhta.2023.2624","url":null,"abstract":"Unmet need: definitions, literature evidence and implications for HTA The present paper illustrates the definition of unmet need provided by the peer-reviewed literature and the Health Technology Assessment (HTA) authorities across Europe in the assessment and appraisal process and within the early access schemes for medicines. The analysis relied on a descriptive review of the peer-reviewed literature and HTA documents on the definition of need (disease severity) and the way it is satisfied (existence and validity of alternatives). HTA agencies were found using (i) a narrow definition of need, focused on the clinical impact and the impact on health-related quality of life of the disease and (ii) a broad definition of comparators, including treatments used off-label in the clinical practice. Most of the contributions of the literature advocated for a broader definition of need, including additional dimensions (for example, the socio-economic impact of the disease) and the effects of existing treatments beyond their risk-benefit profile (for example, acceptability to patients). On the one hand, these contributions should be considered by HTA agencies, considering its multi-disciplinary and multi-stakeholder nature. On the other one, the explicit inclusion of the unmet need domains, at present disregarded, should depend on the decisions taken on the ground of the assessment.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"70-78"},"PeriodicalIF":0.5,"publicationDate":"2023-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/96/f6/grhta-10-70.PMC10551671.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41139058","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}