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羟基脲治疗真性红细胞增多症患者的医疗费用与血栓栓塞事件。

Health Care Costs and Thromboembolic Events in Hydroxyurea-Treated Patients with Polycythemia Vera.

机构信息

1 Incyte Corporation, Wilmington, Delaware.

2 Truven Health Analytics, Cambridge, Massachusetts.

出版信息

J Manag Care Spec Pharm. 2018 Jan;24(1):47-55. doi: 10.18553/jmcp.2018.24.1.47.

DOI:10.18553/jmcp.2018.24.1.47
PMID:29290171
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10397887/
Abstract

BACKGROUND

Patients with polycythemia vera (PV) are at increased risk of thromboembolic events (TEs), which are key contributors to reduced overall survival compared with the age- and sex-matched general population. In addition to aspirin and phlebotomy to maintain hematocrit level < 45%, many patients receive cytoreduction with hydroxyurea (HU), which is associated with improved survival and may reduce the risk of cardiovascular events and TEs. However, 1 in 4 patients become resistant to or intolerant of HU. In the general population, prophylaxis and treatment following arterial and venous thromboses are associated with increased health care resource utilization and costs.

OBJECTIVE

To describe the health care resource utilization and costs associated with TEs in patients with PV treated with HU in the United States.

METHODS

This retrospective cross-sectional analysis of the Truven Health Analytics MarketScan Research Databases included adult patients with a PV diagnosis who were newly treated with HU and continuously enrolled in medical and pharmacy benefit plans for ≥ 12 months pre- and post-index. HU treatment administration, persistence, adherence, and related adverse events, as well as TEs, were reported during the 12-month follow-up period. HU treatment patterns were further analyzed in a subgroup analysis comparing patients with and without a ≥ 45-day gap in HU treatment. Health care resource utilization and costs were analyzed in a subgroup analysis comparing patients who had TEs in the 12-month follow-up period with those who did not. Tests for statistically significant differences across the comparison groups were conducted, including chi-square tests for categorical variables and t-tests for continuous variables.

RESULTS

The records of 1,322 patients with PV were included in this study. Mean age was 66.0 years; 51.3% were men; and 14.0% had a history of TEs. During the first year of HU treatment, 764 (57.8%) patients had a treatment gap of ≥ 45 days; however, treatment adherence was similar between those with and those without a gap (85.2% vs. 90.7%, respectively). TEs occurred in 216 (16.3%) patients within 12 months of HU initiation. Health care resource utilization was higher for patients with TEs versus those without, including the proportion of patients requiring inpatient services (50.9% vs. 18.4%; P < 0.001) and emergency room visits (48.1% vs. 26.3%; P < 0.001) and the mean number of inpatient admissions (1.7 vs. 1.3; P = 0.004); office visits (18.9 vs. 14.1; P < 0.001); and prescriptions (45.8 vs. 36.2; P<0.001). In addition, total mean health care costs ($45,040 vs. $16,438; P < 0.001); inpatient costs ($18,952 vs. $4,794; P < 0.001); outpatient costs ($20,844 vs. $8,046; P < 0.001); and outpatient pharmacy costs ($5,244 vs. $3,598; P = 0.002) were higher among patients with TEs than those without.

CONCLUSIONS

Patients with PV receiving treatment with HU remain at risk for TEs. The occurrence of TEs during the 12-month follow-up in this patient population was associated with higher health care resource utilization and costs.

DISCLOSURES

This study was funded by Incyte Corporation. Parasuraman and Paranagama are employees and stockholders of Incyte Corporation. Shi and Bonafede are employees of Truven Health Analytics, which was awarded a research contract to conduct this study with and on behalf of Incyte Corporation. Study concept and design were contributed by all of the authors, who also interpreted the data and wrote and revised the manuscript. Bonafede and Shi collected the data. This study was presented as an abstract at the Academy of Managed Care Pharmacy NEXUS Annual Meeting on October 26-29, 2015, in Orlando, Florida.

摘要

背景

真性红细胞增多症(PV)患者发生血栓栓塞事件(TEs)的风险增加,与年龄和性别匹配的普通人群相比,TEs 降低了整体生存率。除了用阿司匹林和放血疗法将血细胞比容维持在<45%之外,许多患者接受羟基脲(HU)减容治疗,这与改善生存率相关,并可能降低心血管事件和 TEs 的风险。然而,1/4 的患者对 HU 耐药或不耐受。在普通人群中,动脉和静脉血栓形成后的预防和治疗与增加的医疗保健资源利用和成本相关。

目的

描述在美国接受 HU 治疗的 PV 患者发生 TEs 的医疗保健资源利用和成本情况。

方法

本回顾性横断面分析使用了 Truven Health Analytics MarketScan Research Databases,纳入了新接受 HU 治疗且在索引前和后 12 个月内连续参加医疗和药品福利计划的 PV 诊断成年患者。在 12 个月的随访期间,报告 HU 治疗管理、持续时间、依从性以及相关不良事件和 TEs 的情况。在比较 HU 治疗有或无≥45 天治疗间隙的患者的亚组分析中进一步分析 HU 治疗模式。在比较 12 个月随访期间发生 TEs 和未发生 TEs 的患者的亚组分析中分析医疗保健资源利用和成本。对比较组之间的差异进行统计学显著检验,包括分类变量的卡方检验和连续变量的 t 检验。

结果

这项研究纳入了 1322 例 PV 患者的记录。平均年龄为 66.0 岁;51.3%为男性;14.0%有 TEs 病史。在 HU 治疗的第一年,764 例(57.8%)患者有≥45 天的治疗间隙;然而,治疗依从性在有间隙和无间隙的患者之间相似(分别为 85.2%和 90.7%)。HU 治疗开始后 12 个月内,216 例(16.3%)患者发生 TEs。与无 TEs 的患者相比,发生 TEs 的患者的医疗保健资源利用更高,包括需要住院服务的患者比例(50.9% vs. 18.4%;P < 0.001)和急诊就诊比例(48.1% vs. 26.3%;P < 0.001)以及平均住院入院次数(1.7 次 vs. 1.3 次;P = 0.004);门诊就诊次数(18.9 次 vs. 14.1 次;P < 0.001);以及处方次数(45.8 次 vs. 36.2 次;P<0.001)。此外,总平均医疗保健费用(45040 美元 vs. 16438 美元;P < 0.001);住院费用(18952 美元 vs. 4794 美元;P < 0.001);门诊费用(20844 美元 vs. 8046 美元;P < 0.001);以及门诊药房费用(5244 美元 vs. 3598 美元;P = 0.002)在发生 TEs 的患者中更高。

结论

接受 HU 治疗的 PV 患者仍存在 TEs 风险。在该患者人群中,12 个月随访期间发生 TEs 与更高的医疗保健资源利用和成本相关。

披露

这项研究由 Incyte 公司资助。Parasuraman 和 Paranagama 是 Incyte 公司的员工和股东。Shi 和 Bonafede 是 Truven Health Analytics 的员工,该公司获得了与 Incyte 公司合作并代表其进行这项研究的研究合同。所有作者都提出了研究概念和设计,他们还解释了数据,并撰写和修订了手稿。Bonafede 和 Shi 收集了数据。这项研究在 2015 年 10 月 26 日至 29 日在佛罗里达州奥兰多举行的管理式医疗药师协会 NEXUS 年会上作为摘要进行了介绍。