Bayer AG, Wuppertal, Germany.
Aetion, Boston, MA.
J Manag Care Spec Pharm. 2020 Dec;26(12):1506-1516. doi: 10.18553/jmcp.2020.26.12.1506.
Chronic kidney disease (CKD) is one of the most common complications of type 2 diabetes mellitus (T2D) and results in considerable economic burden. Current studies describing cost and health care resource utilization (HCRU) in T2D patients with CKD in real-world data are few. Even more scarce is evidence that takes into account disease severity and other comorbidities. To (a) describe T2D patients with CKD identified in U.S. administrative claims data using laboratory test results for kidney function that are considered the gold standard criteria for kidney disease diagnosis and (b) estimate the annual HCRU and costs among these patients, overall and by disease severity and comorbidity subgroup. Optum CDM data between the years 2008 and 2017 were used to identify T2D patients with newly recognized CKD, using laboratory test results for estimated glomerular filtration rate (eGFR) or urine albumin-to-creatinine ratio (UACR). The study estimated annualized total, inpatient, outpatient, and pharmacy costs and the number of outpatient, inpatient, and emergency room visits in the first year after CKD identification. Analyses were stratified by prevalent anemia, heart failure (HF), resistant hypertension, and by CKD stages. T2D patients with newly recognized CKD (n = 106,369) had a high prevalence of cardiovascular comorbidities and incurred on average $24,029 of total cost per person per year in the first year after CKD identification. Patients with HF and anemia incurred on average $41,951 and $31,127 of total annual cost, respectively. Patients identified at stage 5 CKD incurred on average $110,210 of total annual cost and had roughly a 7-fold higher annual inpatient hospitalization rate compared with patients identified at stage 1 CKD. Administrative claims data linked to laboratory results provide an opportunity to identify CKD patients using the gold standard criteria from clinical practice, minimizing potential misclassification of patients. Identified CKD patients, particularly those with HF, anemia, and more advanced CKD stage, incur high HCRU and cost. Better monitoring, earlier CKD diagnosis, and interventions that are effective in halting or slowing the progression of CKD, as well as at managing comorbid conditions, could be effective means to reduce the economic burden of CKD in T2D. This study was funded by Bayer. Kelly is an employee of, and owns stock options in, Aetion, which was contracted by Bayer to conduct the study. Petruski-Ivleva was an employee of Aetion during the planning, analysis, and interpretation stages of the study. Kovesdy received honoraria from Amgen, Astra Zeneca, Bayer, Cara Therapeutics, Reata, Takeda, and Tricida. Fried received consultant fees from Bayer, Novo Nordisk, and Bristol-Meyers Squibb. Folkerts, Blankenburg, and Gay are Bayer employees. This work was presented as a poster at the annual European Association for the Study of Diabetes (EASD) conference held in Barcelona, Spain, on September 16-20, 2019.
慢性肾脏病(CKD)是 2 型糖尿病(T2D)最常见的并发症之一,会导致相当大的经济负担。目前,很少有研究描述真实世界数据中 CKD 合并 T2D 患者的成本和医疗资源利用情况(HCRU)。更缺乏的是考虑疾病严重程度和其他合并症的证据。
(a)使用被认为是肾脏疾病诊断金标准的肾功能实验室检测结果,在 U.S. 行政索赔数据中描述 CKD 合并 T2D 患者;(b)总体上以及根据疾病严重程度和合并症亚组,估计这些患者的年度 HCRU 和成本。
2008 年至 2017 年期间,使用 Optum CDM 数据,根据估算肾小球滤过率(eGFR)或尿白蛋白与肌酐比值(UACR)的实验室检测结果,识别新诊断为 CKD 的 T2D 患者。研究估计了 CKD 诊断后第一年的年度总费用、住院费用、门诊费用和药房费用,以及门诊、住院和急诊就诊的次数。分析按现患贫血、心力衰竭(HF)、难治性高血压和 CKD 分期分层。
新诊断为 CKD 的 T2D 患者(n=106369)有很高的心血管合并症患病率,在 CKD 诊断后第一年,每人每年的总费用平均为 24029 美元。HF 和贫血患者的总年度费用分别为 41951 美元和 31127 美元。在 CKD 分期 5 期的患者的年度总费用平均为 110210 美元,与 CKD 分期 1 期的患者相比,每年的住院率约高 7 倍。
与实验室结果相关联的行政索赔数据提供了一个机会,可以使用临床实践中的金标准标准来识别 CKD 患者,从而最大程度地减少患者潜在的分类错误。确定的 CKD 患者,特别是那些有心衰、贫血和更严重 CKD 分期的患者,会产生较高的 HCRU 和成本。更好的监测、更早的 CKD 诊断以及对阻止或减缓 CKD 进展以及管理合并症有效的干预措施,可能是降低 T2D 中 CKD 经济负担的有效方法。
这项研究由拜耳公司资助。Kelly 是 Aetion 的员工,拥有 Aetion 的股票期权,Aetion 受拜耳公司委托进行这项研究。Petruski-Ivleva 在研究的规划、分析和解释阶段是 Aetion 的员工。Kovesdy 从 Amgen、AstraZeneca、Bayer、Cara Therapeutics、Reata、Takeda 和 Tricida 获得了酬金。Fried 从拜耳、诺和诺德和百时美施贵宝收取咨询费。Folkerts、Blankenburg 和 Gay 是 Bayer 的员工。这项工作以海报的形式在 2019 年 9 月 16 日至 20 日在西班牙巴塞罗那举行的第 55 届欧洲糖尿病研究协会(EASD)年会上展示。