Global & Regional Health Technology Assessment最新文献

{"title":"Algoritmo decisionale per l’interpretazione dell’overall survival immatura in onco-ematologia: sviluppo e applicazione.","authors":"Guido Gini, Laura Gurgoglione, Riccardo Ceccarelli, Antonella Poloni","doi":"10.33393/grhta.2026.3798","DOIUrl":"10.33393/grhta.2026.3798","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"177-183"},"PeriodicalIF":0.7,"publicationDate":"2026-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13335633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148436374","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":"Impact of AIFA Note 100 on innovative antidiabetic prescribing eligibility in two Italian local health authorities: drug utilization and patient characteristics.","authors":"Giacomo M Bruno, Maria Chiara Valentino, Stefano Buda, Arrigo Paciello, Stefano Palcic, Giorgio Lorenzo Colombo","doi":"10.33393/grhta.2026.3790","DOIUrl":"10.33393/grhta.2026.3790","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes mellitus (T2DM) is a common chronic disease with management, associated with cardiovascular and renal comorbidities. In January 2022, AIFA Note 100 extended prescribing authority for innovative antidiabetic drugs (SGLT-2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors) to General Practitioners, influencing treatment patterns and management of high-risk patients.</p><p><strong>Methods: </strong>A retrospective observational analysis used administrative data from two Local Health Authorities in Italy, comparing three cohorts: Pre-COVID (2018), COVID (2020-2021), and Post-Note 100 (February 1, 2022 to January 31, 2023). Adults (≥18 years) with at least one prescription of non-insulin glucose-lowering drugs (ATC A10B) were included. Profiles were described, focusing on acarbose, DPP-4 inhibitors, metformin, pioglitazone, SGLT-2 inhibitors, GLP-1 receptor agonists, and sulfonylureas. Clinical characteristics included comorbidities, heart failure, hypertension, and chronic kidney disease. Healthcare costs (pharmaceuticals, outpatient specialist care, and hospitalizations) were analyzed.</p><p><strong>Results: </strong>Over 140,000 subjects were included. In the Post-Note 100 phase, GLP-1 receptor agonists and SGLT-2 inhibitors increased among new users (GLP-1 receptor agonists: 1.2% to 9.3%; SGLT-2 inhibitors: 2.6% to 14.1%) and among prevalent users, with a reduction in sulfonylureas and a decline in metformin monotherapy. Among patients with ≥2 comorbidities, SGLT-2 inhibitors became the most prescribed class. Use rose in heart failure, while both GLP-1 receptor agonists and SGLT-2 inhibitors increased in chronic kidney disease.</p><p><strong>Conclusions: </strong>Expansion of prescribing eligibility introduced by AIFA Note 100 led to a shift toward innovative therapies, aligning prescribing with guidelines, particularly in comorbid patients. Real-world data highlight the impact and support the evaluation of long-term outcomes.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"167-176"},"PeriodicalIF":0.7,"publicationDate":"2026-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13308343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148344831","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":"Impact of Ministerial Decree 77/2022 from different stakeholders' perspectives: clinicians, pharmacists, patients, and industry.","authors":"Guido Attilio Condorelli, Martina Pipoli, Deborah Bonifacio, Andrea Marcellusi, Laura Paganoni","doi":"10.33393/grhta.2026.3664","DOIUrl":"10.33393/grhta.2026.3664","url":null,"abstract":"<p><strong>Introduction: </strong>Assess the implications of Ministerial Decree (MD) 77/2022 in Italy, which decentralizes healthcare through proximity-based models, from the perspective of key actors involved, and discuss its relevance to sustainability and value assessment.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted with four stakeholder groups: pharmaceutical companies, scientific societies, Health Economics and Outcomes Research (HEOR) experts, and patient advocacy organizations (N = 162). Structured questionnaires examined awareness/knowledge, perceived implementation, perceived impact, operational feasibility, and policy alignment.</p><p><strong>Results: </strong>Over 60% of respondents recognized the strategic value of proximity care. Key barriers included administrative burden (47%), resource constraints (38%), and lack of Key Performance Indicator (KPI)-based frameworks (55%). Treatments in oncology, geriatrics, and metabolic diseases were considered most suitable for decentralized provision. Divergent perspectives emerged professional stakeholders emphasized methodological rigour and outcome monitoring, while patient organizations foregrounded equity of access, responsiveness, and patient-facing feasibility.</p><p><strong>Conclusion: </strong>MD 77/2022 opens a policy window to align decentralized care pathways with sustainability and value assessment. However, the survey did not collect empirical pricing, reimbursement, or cost-effectiveness data; therefore, any implications for pricing governance should be interpreted as conceptual and hypothesis-generating rather than as demonstrated effects. Heterogeneous implementation and fragmented outcome measurement remain the primary barriers; a minimum viable KPI set and routine data infrastructure are prerequisites for translating perceived value into decision-relevant evidence.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"156-166"},"PeriodicalIF":0.7,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13281740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148294866","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":"Author's reply to comments to: Italian Medicines Agency's reform and time until pricing and reimbursement decisions: a time-to-event analysis.","authors":"Gian Marco Raspolini, Bruno Federico, Mario Cesare Nurchis, Gianfranco Damiani, Raffaella Cocciolo, Paola Turella, Daniela Pilunni, Pierluigi Navarra","doi":"10.33393/grhta.2026.3827","DOIUrl":"https://doi.org/10.33393/grhta.2026.3827","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"155"},"PeriodicalIF":0.5,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13251727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148224550","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: Italian Medicines Agency's reform and time until pricing and reimbursement decisions: a time-to-event analysis.","authors":"Giuseppe Traversa, Antonio Addis","doi":"10.33393/grhta.2026.3804","DOIUrl":"10.33393/grhta.2026.3804","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"154"},"PeriodicalIF":0.7,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13251728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148224507","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":"Optimizing CAR-T therapy delivery in the Italian healthcare system: economic and organizational insights in follicular lymphoma.","authors":"Andrea Vitagliano, Marzia Bonfanti, Emanuele Angelucci, Alice Di Rocco, Maria Paola Martelli, Elena Del Sarto, Marianna Morani, Chiara Lucchetti, Simona Palladino","doi":"10.33393/grhta.2026.3722","DOIUrl":"10.33393/grhta.2026.3722","url":null,"abstract":"<p><strong>Introduction: </strong>Follicular Lymphoma (FL) is the second most common lymphoid malignancy, with 20% of patients progressing within 24 months of first-line therapy. Chimeric antigen receptor T-cell (CAR-T) therapies have improved outcomes in relapsed or refractory FL, yet their use requires significant resources and complex care pathways. Although outpatient CAR-T programs have shown promising safety and feasibility, limited evidence exists on their organizational, economic, and ethical implications in the Italian healthcare setting. This study compares the current CAR-T pathway for FL patients with a virtual optimized scenario incorporating outpatient management in selected phases.</p><p><strong>Methods: </strong>A multidimensional framework was applied to assess differences between standard in-hospital care (Standard Pathway) across three Italian public hospitals (Genoa, Rome, Perugia) and a partially outpatient model (Efficient Pathway). Literature review and expert consultations validated existing practices and informed optimization criteria. Structured surveys provided quantitative and qualitative inputs. Economic modelling estimated three-year full costs using patient-level data, while organizational and ethical aspects were evaluated through Likert scales.</p><p><strong>Results: </strong>Efficient Pathway shifted bridging therapy, post-infusion monitoring, and follow-up to outpatient settings, reducing total costs from € 611,070 (As-Is) to € 497,421 (To-Be). Organizational benefits included increased bed capacity (average score: 4.9/6) and consumable utilization (average score: 4.3/6), while ethical gains were observed in treatment accessibility (average score: 4.3/6).</p><p><strong>Conclusions: </strong>Introducing outpatient management into CAR-T phases may provide economic, organizational, and ethical advantages when supported by clear eligibility criteria and structured monitoring. As CAR-T indications expand, pathway redesign will be essential to ensure equitable access and sustain healthcare system resources.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"133-145"},"PeriodicalIF":0.7,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148217078","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":"Procedural activity and dynamics of the new Italian Scientific and Economic Committee (CSE): a one-year observational analysis.","authors":"Entela Xoxi, Giulia Fagnocchi, Giovanni Callegaro, Claudia Bertozzi, Rossella Di Bidino, Mariangela Prada","doi":"10.33393/grhta.2026.3756","DOIUrl":"https://doi.org/10.33393/grhta.2026.3756","url":null,"abstract":"<p><strong>Introduction: </strong>In January 2024, the Commissione Scientifica ed Economica (CSE) became the national body responsible for the integrated scientific and economic evaluation of medicines in Italy. This study provides the first systematic description of the CSE's activity during its initial operational year, focusing on procedural workload, timelines, and negotiation outcomes.</p><p><strong>Methods: </strong>All publicly available \"Esiti CSE\" documents published by the Italian Medicines Agency (AIFA) between April 2024 and April 2025 were manually extracted and validated. Each record included the negotiation typology (TN-1 to TN-8), outcome, and iter duration. Descriptive analyses summarised distributions, median and mean durations, deferral rates, and trends over time.</p><p><strong>Results: </strong>A total of 641 procedures (523 products, 446 INNs) generated 2,145 individual outcomes. Argomento rinviato (deferral) was the most frequent outcome (55.7% of all decisions; 51% of procedures). The average procedure involved 1.9 deferrals, and 83% experienced at least one. Mean overall duration was 269 days (median 196; IQR 133-350), with the longest timelines for TN-1 and TN-4 negotiations (298 and 322 days, respectively). Oncology (L01, L04) and metabolic agents (A10) showed the greatest variability, while antivirals (J05) recorded the longest average duration (549 days) but a lower incidence of deferral.</p><p><strong>Conclusions: </strong>The first year of CSE activity reveals a high workload, variable timelines, and frequent deferrals, reflecting the complexity of integrating scientific and economic assessment within a single body. The results provide an empirical baseline for future monitoring and underscore the need for refinement of governance arrangements and procedural transparency in AIFA's new framework.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"146-153"},"PeriodicalIF":0.5,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148217147","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 riforma AIFA e i tempi di valutazione dei nuovi farmaci: l’impatto della nuova Commissione Scientifica ed Economica del Farmaco.","authors":"Benedetta Dal Canto, Vera Benedetto, Alma Martelli, Giovanna Scroccaro, Bruna Vinci","doi":"10.33393/grhta.2026.3736","DOIUrl":"10.33393/grhta.2026.3736","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"125-132"},"PeriodicalIF":0.7,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13186182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981495","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":"More and earlier data from AIFA: do they impact on the regional policies? Results from an exploratory analysis.","authors":"Riccardo Novaro, Mattia Altini, Francesca Futura Bernardi, Francesco Brunetti, Pasquale Carulli, Florapia Giustiniani, Roberta Joppi, Anna Martini, Elisa Sangiorgi, Giovanna Scroccaro, Paolo Stella, Julia Gabriela Szyszko, Ugo Trama, Rosy Amodeo, Mauro Patroncini, Giuliano Buzzetti, Claudio Jommi","doi":"10.33393/grhta.2026.3708","DOIUrl":"10.33393/grhta.2026.3708","url":null,"abstract":"<p><strong>Introduction: </strong>In Italy, drug prices and reimbursement are managed by the Italian Medicines Agency (AIFA), but regions actually enable patient access to medicines. Our aim is to provide evidence on (i) the current management of regional pharmaceutical policies, the use of resources and time to policy completion (TPC-procurement awarding), (ii) the potential impact on resources used and TPC of an earlier-enhanced access of regions to AIFA's data.</p><p><strong>Methods: </strong>Four regions (Veneto, Emilia-Romagna, Campania, Puglia) were selected on a purposive basis. Data on policies and resources used were retrieved from a literature review and interviews with regional officers. TPC was tracked for medicines approved for reimbursement in Italy from January 2023 to June 2024. The potential impact of an earlier-enhanced access to AIFA's data was detected through perceptual questionnaires self-compiled by regional officers.</p><p><strong>Results: </strong>To manage regional access, the regions employ a staff of 21 Full-Time-Equivalent (FTE) persons on average, ranging from 11 to 29. The mean TPC ranges from 135 to 361. The average score of perceived impact of an earlier-enhanced AIFA's data equals 3.3 within a range of 1-4 for both FTE and TPC. An earlier access to public information (e.g., innovativeness appraisal) is perceived as impactful on TPC. Availability of data that are currently not shared with regions may have a greater potential impact on FTE.</p><p><strong>Conclusions: </strong>A great consensus emerged on the importance of timely access to revised P&R data. Systematic early disclosure by AIFA could help to improve efficiency in resource utilization and to expedite patient access to innovative medicines.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"118-124"},"PeriodicalIF":0.7,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13159465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147928653","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":"Cost minimization analysis of subcutaneous and intravenous immunoglobulin treatment in Italy.","authors":"Chiara Bini, Matteo Scortichini, Silvia Ripoli, Laura Fioravanti, Carmela Papa, Paolo Sciattella","doi":"10.33393/grhta.2026.3642","DOIUrl":"10.33393/grhta.2026.3642","url":null,"abstract":"<p><strong>Introduction: </strong>Human immunoglobulins are the standard of care for patients with immunodeficiencies and represent a first-line treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). This study aimed to evaluate costs associated with facilitated subcutaneous (fSCIG), conventional subcutaneous (cSCIG), and intravenous (IVIG) administration of immunoglobulin in patients with primary or secondary immunodeficiency (PID and SID, respectively) and in patients with CIDP in Italy.</p><p><strong>Methods: </strong>A cost-minimization analysis from a societal perspective was developed, considering a one-year follow-up. Direct costs included acquisition and administration costs, while indirect costs were evaluated considering productivity loss due to in-hospital IVIG using a Human Capital Approach. The posology considered for immunodeficiency disorders and CIDP was obtained from observational studies and clinical trials, respectively. Subcutaneous and intravenous administration costs were obtained from published literature. Scenario analyses were conducted to test the key assumptions of the model.</p><p><strong>Results: </strong>This study indicates a potential reduction of annual societal expenditure in Italy of approximately €2,145 and €1,605 with fSCIG treatment in PID patients compared to cSCIG and IVIG, respectively. In SID patients, fSCIG would result in a reduction of societal expenditure of approximately €2,145 and €2,071 compared to cSCIG and IVIG. For CIDP patients, fSCIG treatment would result in a reduction of societal expenditure of €8,060 and €15,873 compared to cSCIG and IVIG, respectively.</p><p><strong>Conclusion: </strong>The use of fSCIG for patients with PIDs, SIDs or CIDP could lead to a reduction in the direct and indirect costs associated with the treatment of patients.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"13 ","pages":"109-117"},"PeriodicalIF":0.7,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13136886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147836970","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}