Cost-Effectiveness of Empagliflozin (JARDIANCE®) in the Treatment of Patients with Chronic Kidney Disease in France, Based on the EMPA-KIDNEY Clinical Trial.

IF 2.9 3区 医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2024-10-24 DOI:10.1007/s40261-024-01398-4
Harinala Groyer, Romain Supiot, Jean Tardu, Nicolas Virely, Marine Sivignon, Denis San, Pierre Lévy, Anastasia Ustyugova, Ziad A Massy
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Abstract

Background and objective: The efficacy and safety of empagliflozin in the treatment of chronic kidney disease (CKD) were demonstrated in the EMPA-KIDNEY trial, which showed a 28% reduction in combined risks of kidney disease or death from cardiovascular causes (hazard ratio, 0.72; 95% confidence interval, 0.64-0.82; p < 0.001) compared with placebo. Based on these results, the present study aimed to assess the cost-effectiveness of empagliflozin + standard of care (SoC) compared with SoC alone in the treatment of CKD in France.

Methods: A Markov state microsimulation model was adapted to compare the health and economic outcomes in France, considering a healthcare system perspective, in patients treated with empagliflozin in addition to SoC versus patients treated with SoC alone. The model simulated the intention-to-treat population of the trial, transitioning between 18 mutually exclusive and collectively exhaustive health states defined based on the Kidney Disease: Improving Global Outcomes classification. For each arm, the model estimated (over a 25-year time horizon) the number of events and deaths, and the costs associated with these events, to calculate the incremental cost-effectiveness ratio. The resources used were derived using French authorities reports, literature, and French CKD guidelines. Both economic and health outcomes were discounted at a 2.5% annual rate according to French guidelines.

Results: The model predicted that using empagliflozin + SoC to treat patients with CKD would prevent CKD-related complications and deaths associated with a cardiovascular event or all-cause deaths while in kidney replacement therapy, resulting on average in a discounted gain of 1.29 years in overall survival (9.48 years vs. 8.19 with SoC alone). Empagliflozin costs (treatment, events, and disease management) were completely offset by the cost savings from avoided kidney failure events. Overall, empagliflozin + SoC would be more effective and less costly than SoC alone and would therefore be the dominant treatment strategy. The sensitivity analyses conducted support the results' robustness in showing the dominance of empagliflozin + SoC over SoC alone.

Conclusions: The base-case results indicate that empagliflozin + SoC is a dominant strategy compared with the current SoC for the management of CKD in France. Empagliflozin + SoC would have a positive impact on patients with CKD by slowing CKD progression and leading to the prevention of kidney failure events on top of all-stages CKD complications.

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基于 EMPA-KIDNEY 临床试验的 Empagliflozin (JARDIANCE®) 治疗法国慢性肾病患者的成本效益。
背景和目的:EMPA-KIDNEY试验显示,与安慰剂相比,empagliflozin治疗慢性肾脏病(CKD)的疗效和安全性降低了28%(危险比为0.72;95%置信区间为0.64-0.82;P < 0.001)。基于这些结果,本研究旨在评估在法国治疗慢性肾脏病时,empagliflozin+标准疗法(SoC)与单独使用标准疗法相比的成本效益:采用马尔可夫状态微观模拟模型,从医疗保健系统的角度出发,比较在法国接受empagliflozin+SoC治疗的患者与仅接受SoC治疗的患者的健康和经济结果。该模型模拟了试验中的意向治疗人群,在根据肾脏疾病分类界定的 18 种相互排斥且共同详尽的健康状态之间转换:改善全球疗效》分类法定义的 18 种相互排斥且共同详尽的健康状态之间转换。对于每个治疗组,该模型(在 25 年的时间跨度内)估算了事件数和死亡数,以及与这些事件相关的成本,从而计算出增量成本效益比。所使用的资源来自法国权威报告、文献和法国慢性肾脏病指南。根据法国指南,经济和健康结果均按2.5%的年贴现率进行贴现:该模型预测,使用恩格列净+SoC治疗CKD患者可预防CKD相关并发症、心血管事件相关死亡或肾脏替代治疗期间的全因死亡,平均可使总生存期折现延长1.29年(9.48年与单独使用SoC的8.19年相比)。因避免肾衰竭事件而节省的成本完全抵消了恩格列净的成本(治疗、事件和疾病管理)。总体而言,与单独使用 SoC 相比,恩格列净 + SoC 的疗效更好、成本更低,因此是最主要的治疗策略。所进行的敏感性分析支持了结果的稳健性,显示了恩格列净+SoC比单独使用SoC更有优势:基础研究结果表明,在法国,与目前的SoC相比,empagliflozin + SoC是治疗CKD的主要策略。Empagliflozin + SoC 将对慢性肾功能衰竭患者产生积极影响,因为它能减缓慢性肾功能衰竭的进展,并在所有阶段的慢性肾功能衰竭并发症基础上预防肾衰竭事件的发生。
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来源期刊
CiteScore
5.90
自引率
3.10%
发文量
108
审稿时长
6-12 weeks
期刊介绍: Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.
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