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Health technology assessment (HTA) of prostatic urethral lift (PUL) for the treatment of benign prostatic hyperplasia (BPH) in the Italian context. 意大利前列腺尿道提升术(PUL)治疗良性前列腺增生(BPH)的健康技术评估(HTA)
IF 0.5 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-07-22 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3401
Agostino Fortunato, Filippo Rumi, Debora Antonini, Michele Basile, Eugenio Di Brino

Background: Health technology assessment (HTA) is a process evaluating various aspects of healthcare technologies to support evidence-based decisions. Benign prostatic hyperplasia (BPH) is a common condition among aging men, significantly affecting QoL. Traditional treatments like transurethral resection of the prostate (TURP) and Holmium Laser Enucleation (HoLEP) are effective but often associated with complications and sexual dysfunction. The Prostatic Urethral Lift (PUL) system (UroLift) offers a minimally invasive alternative, preserving sexual function and ensuring faster recovery.

Methods: Using the EUnetHTA Core Model 3.0, UroLift was evaluated across nine domains, combining a systematic review of literature, expert consultation, and real-world evidence. A Budget Impact Model (BIM) simulated treatment pathways over five years, comparing UroLift with TURP and HoLEP.

Results: As the analysis shows, despite the higher initial acquisition cost, UroLift generates savings for the NHS in all the years considered within the analysis. Specifically, savings are derived from the lower incidence of adverse events and complications, both post-operative and in the long term, implying lower inpatient costs and less use of human resources. As anticipated, savings begin in the first year with a differential between the two scenarios considered at 57,747.40 and peak in the fifth year with savings of approximately €1.35 million, for a total estimated savings over the considered time horizon, considering the market shares, of €3,154,997.63.

Conclusions: UroLift demonstrates clinical efficacy, faster recovery, and sexual function preservation while generating cost savings, supporting its integration into BPH management pathways in Italy.

背景:卫生技术评估(HTA)是一个评估卫生保健技术的各个方面以支持循证决策的过程。良性前列腺增生(BPH)是老年男性的常见病,显著影响生活质量。传统的治疗方法,如经尿道前列腺切除术(TURP)和钬激光摘除(HoLEP)是有效的,但往往伴随着并发症和性功能障碍。前列腺尿道提升(PUL)系统(UroLift)提供了一种微创的选择,保留性功能并确保更快的恢复。方法:采用EUnetHTA Core Model 3.0,结合文献系统综述、专家咨询和现实证据,对UroLift进行9个领域的评估。预算影响模型(BIM)模拟了五年的治疗路径,将UroLift与TURP和HoLEP进行了比较。结果:正如分析所显示的,尽管初始收购成本较高,但在分析所考虑的所有年份中,UroLift都为NHS节省了成本。具体来说,节省来自术后和长期不良事件和并发症的发生率较低,这意味着住院费用较低,人力资源的使用较少。正如预期的那样,第一年开始节省,两种情况之间的差额为57,747.40,第五年达到峰值,节省约135万欧元,考虑到市场份额,在考虑的时间范围内估计总节省为3,154,997.63欧元。结论:UroLift具有临床疗效、更快的恢复和性功能保护,同时节省了成本,支持其融入意大利BPH管理途径。
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引用次数: 0
Analisi di costo-efficacia di nirmatrelvir/ritonavir in pazienti adulti ad alto rischio di progressione a COVID-19 severo. nirmatrelvir/ritonavir的成本效益分析
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-07-17 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3403
Carolina Moreno, Andrea Aiello, Roberto Di Virgilio, Valentina Mazzotta, Andrea Antinori
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引用次数: 0
Real-World Evidence e Managed Entry Agreements. 真实世界证据管理进入协议。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-07-09 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3563
Silvia Adami, Cosetta Bianchi, Elisa Crovato, Gianluca Trifirò
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引用次数: 0
C(nn) e uso compassionevole: due approcci per l’early access. Proposte per una migliore gestione. C(nn)和富有同情心的使用:快速访问的两种方法。改善管理的建议。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-06-10 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3464
Alberto Bortolami, Irene Marzona, Paolo Stella, Valentina Acciai, Vito Ladisa, Massimo Medaglia
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引用次数: 0
Cost-analysis from real-world REDS study on dalbavancin in inpatient treatment of acute bacterial skin and skin structure infections. 达尔巴文星治疗急性细菌性皮肤和皮肤结构感染住院患者的实际red研究成本分析。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-06-09 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3363
Matteo Scortichini, Alessandro Ruggieri, Agnese Cattaneo, Patrizia Mascagni, Paolo Sciattella

Introduction: Inpatient treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) involves a significant economic burden on the healthcare system.The aim of the present analysis was to estimate the expenditure, in terms of direct and indirect healthcare costs, for patients hospitalized with a confirmed diagnosis of ABSSSI, evaluating the impact of dalbavancin, compared to the other Standard of Care of the same IV antibiotic class, analyzed in the REDS study.

Methods: The analysis was carried out using data collected as part of the study "Retrospective Effectiveness study of dalbavancin and other Standard of care of the same class IV lipo and glycopeptides) in patients with ABSSSI" (REDS study).In the present analysis, the economic impact of managing patients hospitalized for ABSSSI was estimated by evaluating both the direct healthcare costs relating to hospital and pharmaceutical care and the indirect costs relating to the loss of productivity due to the pathology.

Results and conclusions: The analysis of data from the REDS study made it possible to estimate the economic impact of the management of patients hospitalized for ABSSSI, depending on the treatment received during hospitalization.The results highlighted a reduction in costs for patients treated with dalbavancin, both for direct healthcare costs and indirect costs, over the entire observation period. Again, the reduction increases, reaching statistical significance, and the costs are evaluated from the beginning of the treatment.

简介:急性细菌性皮肤和皮肤结构感染(ABSSSIs)的住院治疗涉及医疗保健系统的重大经济负担。本分析的目的是估计确诊为ABSSSI的住院患者的直接和间接医疗费用支出,与red研究中分析的其他相同IV抗生素类别的标准护理相比,评估达尔巴文星的影响。方法:采用“达尔巴文星及其他同类IV类脂质和糖肽类标准护理药物对ABSSSI患者的回顾性疗效研究”(REDS研究)中收集的数据进行分析。在本分析中,通过评估与医院和药物护理相关的直接医疗保健成本以及与病理导致的生产力损失相关的间接成本,估计了管理因ABSSSI住院的患者的经济影响。结果和结论:通过对REDS研究数据的分析,可以根据住院期间接受的治疗来估计对ABSSSI住院患者进行管理的经济影响。结果突出表明,在整个观察期内,dalbavancin治疗患者的成本降低了,无论是直接医疗成本还是间接成本。同样,减少量增加,达到统计学意义,并且从治疗开始就评估成本。
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引用次数: 0
Valutazione dei tempi di accesso per le nuove entità chimiche in Italia: un’analisi critica del periodo 2018-2024. 意大利新化学实体进入时间的评估:对2018-2024年期间的关键分析。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-05-16 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3422
Alessandro Tedesco, Marzia Bonfanti, Asia Barugolo, Fulvio Luccini, Patrizia Berto
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引用次数: 0
Healthcare of patients with immunoglobulin A nephropathy through a retrospective observational study of Italian administrative data. 免疫球蛋白A肾病患者的保健通过意大利行政数据的回顾性观察研究。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-05-15 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3397
Luigi Biancone, Gaetano La Manna, Letizia Dondi, Leonardo Dondi, Giulia Ronconi, Silvia Calabria, Irene Dell'Anno, Carlo Piccinni, Immacolata Esposito, Alice Addesi, Nello Martini

Background: Immunoglobulin A nephropathy (IgAN) is a rare disease poorly described in real-world settings. This observational retrospective study aimed to assess the direct healthcare burden of new IgAN patients on the Italian National Healthcare Service (SSN).

Methods: From the Fondazione Ricerca e Salute's database (administrative healthcare data of ~5.5 million inhabitants/year), inpatients with new potential in-hospital biopsy-verified IgAN from 2016 to 2019 were identified. Dispensations of IgAN-recommended and other drugs, kidney replacement therapies (KRT), hospital and emergency department (ED) admissions, local outpatient specialist care, and related direct costs were assessed throughout a 3-year follow-up.

Results: New IgAN patients (n = 292) were identified (incidence/year: 1.25/100 000 inhabitants); 64% of patients were male; the median age was 41 (27; 57) years. Annual consumption of most healthcare resources decreased from Year 1 to 3: from 90% to 84% of patients received ≥1 IgAN-recommended drug; from 100% (due to selection criteria) to 15% of patients underwent overnight hospitalizations; from 8% to 3% patients underwent day hospitalizations; from 31% to 21% patients underwent ≥1 ED access; from 87% to 85% patients received local outpatient specialist services. Of all patients, 2-4% were treated with KRT, and ~91% received other drugs. The per capita mean total annual cost was €7441 in Year 1 (hospitalizations accounting for 73% due to selection criteria), €3497 in Year 2, and €3243 in Year 3 (drugs accounting for 51%, mostly attributable to other drugs).

Conclusion: This real-world study shows a substantial direct healthcare burden for new IgAN patients arising from IgAN-specific care and comorbidities.

背景:免疫球蛋白A肾病(IgAN)是一种罕见的疾病,在现实世界中很少被描述。本观察性回顾性研究旨在评估新IgAN患者在意大利国家医疗保健服务(SSN)上的直接医疗负担。方法:从国家卫生基金会数据库(约550万居民/年的行政卫生保健数据)中,筛选出2016 - 2019年住院活检证实的新潜在IgAN患者。在为期3年的随访中,评估了igan推荐的药物和其他药物的配药、肾脏替代疗法(KRT)、医院和急诊科(ED)入院、当地门诊专科护理和相关的直接费用。结果:发现了新的IgAN患者(n = 292)(发病率/年:1.25/10万居民);64%的患者为男性;中位年龄41岁(27岁;57年。从第1年到第3年,大多数医疗资源的年消耗量下降:从90%到84%的患者接受≥1种igan推荐药物;100%(根据选择标准)至15%的患者接受过夜住院治疗;8%至3%的患者接受了日间住院治疗;从31%到21%的患者接受了≥1次ED通路;87%至85%的患者接受了当地门诊专科服务。在所有患者中,2-4%接受KRT治疗,约91%接受其他药物治疗。人均年平均总费用第一年为7441欧元(因选择标准住院费用占73%),第二年为3497欧元,第三年为3243欧元(药物费用占51%,主要为其他药物)。结论:这项现实世界的研究表明,由于IgAN特异性护理和合并症,新IgAN患者的直接医疗负担很大。
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引用次数: 0
Cost-effectiveness of cenobamate as a therapeutic alternative for the treatment of focal epilepsy in adults with inadequate seizure control. 辛奥巴酸作为治疗局灶性癫痫控制不充分的成人的替代治疗方案的成本效益。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-05-09 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3341
Martina Paoletti, Angela Ragonese, Luca Budassi, Andrea Marcellusi

Introduction: This study assesses the cost-effectiveness of cenobamate relative to brivaracetam, lacosamide, eslicarbazepine acetate, and perampanel in the management of focal onset seizures (FOS). The objective is to determine whether cenobamate offers enhanced therapeutic benefits and economic viability.

Methods: A comprehensive cost-effectiveness analysis was performed using a lifetime horizon model that encompassed drug acquisition costs, background therapy, monitoring, and seizure management expenses. The incremental cost-effectiveness ratio (ICER) was calculated to evaluate the quality-adjusted life years (QALYs) gained from cenobamate compared to its alternatives.

Results: Findings revealed that cenobamate while incurring slightly higher initial acquisition costs, leads to significant cost offsets due to reductions in overall seizure management expenses and minimized reliance on subsequent anti-seizure medications (ASMs). Additionally, cenobamate significantly enhances patient quality of life, demonstrated by superior response rates (seizure reduction >50%) and remission rates (100% seizure reduction) compared to the analyzed comparators. The cost-effectiveness analysis established that cenobamate is dominant across all evaluated treatment options, achieving greater QALYs at a lower total cost.

Conclusion: Cenobamate represents a more effective and economically advantageous treatment for patients with FOS when compared to brivaracetam, lacosamide, eslicarbazepine acetate, and perampanel. Its capacity to improve seizure control and enhance the quality of life, alongside favorable economic implications, underscores its position as the preferred therapeutic option in this patient population.

本研究评估了相对于布瓦西坦、拉可沙胺、醋酸埃斯卡巴西平和perampanel在局灶性癫痫发作(FOS)治疗中的成本-效果。目的是确定cenobamate是否提供增强的治疗效益和经济可行性。方法:采用涵盖药物获取成本、背景治疗、监测和癫痫发作管理费用的生命周期水平模型进行综合成本-效果分析。计算增量成本-效果比(ICER)来评估从cenobamate获得的质量调整寿命年(QALYs)。结果:研究结果显示,虽然cenobamate的初始获取成本略高,但由于减少了总体癫痫管理费用,并最大限度地减少了对后续抗癫痫药物(asm)的依赖,因此可以显著抵消成本。此外,与分析的比较物相比,cenobamate显著提高了患者的生活质量,表现为更高的反应率(癫痫发作减少50%)和缓解率(癫痫发作减少100%)。成本-效果分析表明,cenobamate在所有评估的治疗方案中占主导地位,以较低的总成本获得更高的质量年。结论:与布瓦西坦、拉可沙胺、醋酸埃斯卡巴西平和perampanel相比,Cenobamate对FOS患者是一种更有效、更经济的治疗方法。其改善癫痫发作控制和提高生活质量的能力,以及有利的经济影响,强调了其作为该患者群体首选治疗方案的地位。
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引用次数: 0
Analisi di costo-efficacia di Brentuximab Vedotin + CHP in pazienti con linfoma anaplastico a grandi cellule sistemico. Brentuximab Vedotin + CHP的成本效益分析,用于全身大细胞anapltif患者。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-04-30 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3306
Andrea Marcellusi, Chiara Bini, Laura Fioravanti, Silvia Ripoli, Paolo Morelli
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引用次数: 0
Gli strumenti regionali di governo del comportamento prescrittivo e della spesa farmaceutica: dalla letteratura alle esperienze concrete e raccomandazioni di un panel di esperti. 管理处方行为和药物支出的区域工具:从文献到专家小组的实际经验和建议。
IF 0.4 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-04-24 eCollection Date: 2025-01-01 DOI: 10.33393/grhta.2025.3324
Giovanna Scroccaro, Luca Piccoli, Giacomo Vitturi, Maria Cristina Carena, Gianfranco Valenzano
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引用次数: 0
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Global & Regional Health Technology Assessment
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