Joint Clinical Assessment in the EU HTA Regulation-Would Drugs Supported by Single-Arm Trials Fit Under Evaluation? [0.03%]
欧盟HTA条例下的联合临床评估-单臂试验支持的药物能被纳入评估范围吗？
Krzysztof Kloc,Mondher Toumi,Elżbieta Łukomska et al.
Krzysztof Kloc et al.
The Joint Clinical Assessment (JCA) evaluates the relative effectiveness (RE) of interventions over comparators. While randomised control trials (RCTs) are considered the gold standard, single-arm trials (SATs) require an external control f...
Supporting the Implementation and Addressing the Challenges of the EU HTA Regulation [0.03%]
支持欧盟HTA条例的实施并应对挑战
Elaine Julian,Mondher Toumi,Fabrizio Gianfrate et al.
Elaine Julian et al.
Four years after the European Regulation on Health Technology Assessment (EU HTAR) came into force and a little over a year after the implementation phase of the Regulation started, with the publication of the first Joint Clinical Assessmen...
Operative Costs and Anesthesia Exposure Time for Pediatric Glaucoma Surgeries [0.03%]
儿童青光手术的运营成本和麻醉暴露时间
Scott D Sorenson,Raymond G Areaux Jr
Scott D Sorenson
Background: Pediatric glaucomas are sight-threatening conditions that frequently require surgical intervention and may expose vulnerable young patients to repeated episodes of general anesthesia. While the clinical efficacy of pediatric gla...
A Decision Tree Cost Analysis of Intracranial Bleed Detection Using a Near-Infrared Device Across Various Healthcare Levels [0.03%]
近红外装置在不同级别的医疗环境中检测颅内出血的决策成本分析树模型
Mamta Patel,Amit Kumar Mittal,Mohit Agrawal et al.
Mamta Patel et al.
Traumatic brain injury (TBI), mainly caused by road traffic accidents, is a serious global public health concern. Computed tomography (CT) is the best way to detect intracranial haemorrhage (ICH), but it is not always feasible because it is...
Use of Real-World Evidence in Health Technology Assessments of Non-Oncology Rare Disease Therapies [0.03%]
真实世界证据在罕见病非肿瘤药物健康技术评估中的应用
Oliver Blandy,Pierluigi Lembo,Rebecca Folorunso et al.
Oliver Blandy et al.
Background: Real-world evidence (RWE) can complement clinical trials to inform health technology assessments (HTAs). This study examined the extent to which RWE is considered in HTAs of non-oncology orphan medicinal products across six agen...
Mondher Toumi,Bruno Falissard,Steven Simoens et al.
Mondher Toumi et al.
Words matter because they have profound power to shape thoughts, emotions, actions, and social realities [...].
Between Rigor and Relevance: Why the EU HTA Guidelines on Indirect Comparisons Miss the Mark [0.03%]
严谨与现实之间：为什么欧盟的间接比较指南难以达到目标
Samuel Aballéa,Mondher Toumi,Piotr Wojciechowski et al.
Samuel Aballéa et al.
Indirect treatment comparisons (ITCs) are essential in the context of joint clinical assessments (JCAs) under Regulation (European Union [EU]) 2021/2282, bridging evidence gaps where head-to-head data are lacking and enabling assessment acr...
Impact of a Digital Leakage Notification System on Healthcare Resource Utilisation and Costs for People with Stomas in the United Kingdom: Analysis of Interim Results from a Prospective Longitudinal Study [0.03%]
英国数字泄漏提醒系统对造口人医疗资源使用及费用的影响：前瞻性纵向研究中期结果分析
Alexandra Baxter,Esben Bo Boisen,Majken Linnemann Jensen et al.
Alexandra Baxter et al.
Background/Objectives: Leakage of stomal effluent adversely affects the quality of life for people living with a stoma and increases healthcare resource utilisation and costs. The Heylo™ digital leakage notification system (DLNS) detects e...
Assessment and Appraisal of Drug Innovativeness in Italy: Ultimate Evidence on Key Drivers and Consistency [0.03%]
意大利药品创新性评价与估价：关键驱动因素及一致性的最终证据
Alvise Verde,Federica Turati,Clara Trimarchi et al.
Alvise Verde et al.
This study aims to update and integrate empirical evidence on the key drivers and consistency of the appraisals of drug innovativeness in Italy by the Italian Medicines Agency (AIFA), and discuss if this evidence is supportive of the reform...
Primary Care or Primary Problem? Aligning Access Pathways with Patient Needs Across the Care Continuum [0.03%]
基层医疗还是主要问题？跨越护理连续性范围与患者需求一致的访问途径
Gregory J Privitera,James J Gillespie,Alexa Walton
Gregory J Privitera
In the United States, access to healthcare is shaped not only by patient need but also by payer policies that determine which providers are reimbursable, how care is sequenced, and what constitutes a legitimate entry point into the system. ...