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美国新诊断且未使用口服抗凝剂的非瓣膜性心房颤动患者接受达比加群或华法林治疗的医疗资源利用和成本

Health Care Resource Utilization and Costs Among Newly Diagnosed and Oral Anticoagulant-Naive Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran or Warfarin in the United States.

机构信息

1 HealthCore, Wilmington, Delaware.

2 Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut.

出版信息

J Manag Care Spec Pharm. 2018 Jan;24(1):73-82. doi: 10.18553/jmcp.2018.24.1.73.

Abstract

BACKGROUND

Warfarin has a long history of use to reduce the risk of stroke in patients with atrial fibrillation (AF), but it requires frequent laboratory monitoring to maintain international normalized ratio levels in the therapeutic range. Dabigatran, a novel oral anticoagulant (OAC), has demonstrated efficacy in reducing the risk of stroke and systemic embolism and does not require laboratory monitoring.

OBJECTIVE

To compare health care resource utilization (HCRU) and costs of OAC-naive patients newly diagnosed with nonvalvular atrial fibrillation (NVAF), using dabigatran or warfarin.

METHODS

This retrospective observational study used data from medical and pharmacy claims extracted from the HealthCore Integrated Research Database representing commercial and Medicare Advantage members. Adults aged > 18 years with a medical diagnosis claim of NVAF were identified between October 1, 2010, and December 31, 2011. The date of first observed OAC prescription claim was the index date. Patients were followed for up to 12 months after the index date. Patients were assigned to the dabigatran or warfarin treatment groups based on their first OAC prescription fills. To reduce potential for selection bias, the cohorts were matched on baseline characteristics using propensity score matching. HCRU was measured and compared between groups on a per-patient-per-month (PPPM) basis for all-cause HCRU, as well as stroke, myocardial infarction, and bleed-specific HCRU. Pharmacy, medical, and total costs were also compared and adjusted to 2012 U.S. dollars. Generalized linear models were conducted to compare all-cause health care costs between cohorts.

RESULTS

After propensity score matching, 1,648 patients were included in the analysis (824 each in the dabigatran and warfarin treatment groups). In the post-index period, patients in the dabigatran group had significantly fewer all-cause PPPM physician office visits (mean [SD] 1.29 [± 0.95] vs. 2.02 [± 1.53], P < 0.001) and outpatient visits (mean [SD] 2.17 [± 2.90] vs. 3.52 [± 3.32], P < 0.001) compared with those in the warfarin group. There were no between-group differences in outcomes for the number of stroke, myocardial infarction, or bleeding-related office visits. All-cause medical costs for the dabigatran cohort were lower than the warfarin cohort; however, the difference did not reach statistical significance ($2,696 [SD ± $6,699] vs. $2,893 [± $6,819], P = 0.179). All-cause pharmacy costs were higher in the dabigatran group versus the warfarin group ($455 [± $429] vs. $328 [± $517], P < 0.001). The dabigatran cohort also had significantly higher stroke-related ($32 [± $71] vs. $20 [± $55], P = 0.006) and nonstroke-related pharmacy costs ($423 [± $422] vs. $308 [± $515], P < 0.001). Despite higher pharmacy costs for the dabigatran cohort, both treatment groups had statistically similar all-cause total costs ($3,151 [± $6,744] vs. $3,221 [± $6,869], P = 0.701).

CONCLUSIONS

This real-world study showed that among patients newly diagnosed with NVAF who were OAC naive, dabigatran use was associated with significantly less HCRU in terms of physician and outpatient visits but higher pharmaceutical costs in up to 12 months of follow-up. Similar to other real-world studies, this research supports the finding that higher pharmacy costs for dabigatran users was offset by lower medical costs, making total health care costs comparable between dabigatran and warfarin.

DISCLOSURES

This work was supported by Boehringer Ingelheim Pharmaceuticals, which is the manufacturer of dabigatran, one of the products included in the analysis of this work. The authors were responsible for all content and editorial decisions. Jain and Tan are employed by HealthCore, a research consultancy which was funded by Boehringer Ingelheim Pharmaceuticals for work on this study. Fu was employed by HealthCore at the time of this study. Lim, Wang, Elder, and Sander are employees of Boehringer Ingelheim Pharmaceuticals. Study concept and design were contributed by Wang, Sander, and Tan, along with Fu and Jain. Fu, Tan, and Jain collected the data, and data interpretation was performed by Lim, Wang, and Sander, along with Jain, Tan, and Fu. The manuscript was written by Jain, Elder, Tan, and Wang, along with Lim and Fu, and revised by Jain, Wang, Elder, and Tan. Some of the results of this study were presented at Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke (QCOR) 2014 Scientific Sessions on June 2-4, 2014, in Baltimore, Maryland.

摘要

背景

华法林在降低非瓣膜性心房颤动(NVAF)患者中风风险方面具有悠久的历史,但需要频繁的实验室监测以维持国际标准化比值(INR)在治疗范围内。达比加群酯是一种新型口服抗凝剂(OAC),已被证明能有效降低中风和全身性栓塞的风险,且无需实验室监测。

目的

比较新诊断为 NVAF、未使用过 OAC 的患者使用达比加群酯或华法林的医疗资源利用(HCRU)和成本。

方法

这是一项回顾性观察性研究,使用了从 HealthCore 综合研究数据库中提取的医疗和药房索赔数据,该数据库代表了商业和医疗保险优势成员。在 2010 年 10 月 1 日至 2011 年 12 月 31 日期间,筛选出 NVAF 医学诊断索赔的成年患者(>18 岁)。首次观察到 OAC 处方索赔的日期为索引日期。患者在索引日期后最多随访 12 个月。根据他们的首次 OAC 处方情况,将患者分配到达比加群酯或华法林治疗组。为了减少选择偏倚的可能性,使用倾向评分匹配(propensity score matching)对两组患者进行了基线特征匹配。以每个患者每月(PPPM)为基础,比较两组之间所有原因 HCRU 以及中风、心肌梗死和出血特定 HCRU 的 HCRU。还比较和调整了药房、医疗和总费用,以 2012 年美元计价。使用广义线性模型比较了两组的全因医疗费用。

结果

在进行倾向评分匹配后,共有 1648 名患者纳入分析(达比加群酯和华法林治疗组各 824 名)。在索引后时期,达比加群酯组的所有原因 PPPM 医生就诊次数(平均值[标准差]为 1.29[±0.95])和门诊就诊次数(平均值[标准差]为 2.17[±2.90])明显少于华法林组(分别为 2.02[±1.53]和 3.52[±3.32])(均 P<0.001)。两组之间中风、心肌梗死或出血相关就诊次数无差异。达比加群酯组的全因医疗费用低于华法林组;然而,差异无统计学意义($2696[SD ±$6699] vs. $2893[±$6819],P=0.179)。达比加群酯组的全因药房费用高于华法林组($455[±$429] vs. $328[±$517],P<0.001)。达比加群酯组还具有显著更高的中风相关($32[±$71])和非中风相关($423[±$422])的药房费用(均 P<0.001)。尽管达比加群酯组的药房费用较高,但两组的全因总费用均具有统计学相似性($3151[±$6744] vs. $3221[±$6869],P=0.701)。

结论

这项真实世界研究表明,在新诊断为 NVAF、OAC 初治的患者中,与华法林相比,达比加群酯使用与医生和门诊就诊次数显著减少有关,但在 12 个月的随访中,药物成本更高。与其他真实世界研究一样,这项研究支持了达比加群酯使用者较高的药房成本被较低的医疗成本所抵消的发现,从而使达比加群酯和华法林的总体医疗成本相当。

披露

这项工作得到了勃林格殷格翰制药公司的支持,该公司是达比加群酯的制造商,也是这项工作分析的产品之一。作者对所有内容和编辑决策负责。Jain 和 Tan 受雇于 HealthCore,这是一家研究咨询公司,受勃林格殷格翰制药公司委托进行了这项研究。Fu 在研究期间受雇于 HealthCore。Lim、Wang、Elder 和 Sander 是勃林格殷格翰制药公司的员工。Wang、Sander 和 Tan 提出了研究概念和设计,与 Fu 和 Jain 一起收集了数据,并进行了数据解释。Jain、Tan 和 Fu 撰写了手稿,Wang、Elder 和 Tan 进行了修订。本研究的部分结果于 2014 年 6 月 2 日至 4 日在马里兰州巴尔的摩举行的心血管疾病和中风质量护理与成果研究(QCOR)2014 科学会议上进行了介绍。

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