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美国针对心房颤动且有高卒中风险患者的抗凝管理服务的成本效益

The cost effectiveness of anticoagulation management services for patients with atrial fibrillation and at high risk of stroke in the US.

作者信息

Sullivan Patrick W, Arant Thomas W, Ellis Samuel L, Ulrich Heather

机构信息

Pharmaceutical Outcomes Research Program, Department of Clinical Pharmacy, School of Pharmacy, University of Colorado at Denver and Health Sciences Center, CO 80262, USA.

出版信息

Pharmacoeconomics. 2006;24(10):1021-33. doi: 10.2165/00019053-200624100-00009.

Abstract

BACKGROUND

Anticoagulation therapy with warfarin is widely considered the standard of care for stoke prophylaxis in patients with atrial fibrillation who are at high risk of stroke. Community-based studies in the US have reported that the effectiveness of anticoagulation varies by management approach and that patients receiving warfarin have international normalised ratio (INR) values within the target therapeutic range less than half the time.

OBJECTIVE

To estimate the lifetime societal costs and health benefits of warfarin therapy to prevent strokes, specifically in elderly patients (mean age 70 years) with atrial fibrillation who are at high risk of stroke, when anticoagulation is managed through usual care versus anticoagulation management services, where dedicated anticoagulation professionals (e.g. physician or pharmacist) monitor and oversee patients.

METHODS

Semi-Markov decision model with a 30-day cycle length and 10-year time horizon (to reflect the mean life expectancy of the study population). Univariate sensitivity analyses and Bayesian second-order multivariate probabilistic sensitivity analysis using Monte Carlo simulation were performed. Outcomes measures were costs and QALYs. Most of the probability and outcome estimates included were derived from the recent SPORTIF (Stroke Prevention using ORal Thrombin Inhibitor in atrial Fibrillation) V trial. Utility values were derived from a large, nationally representative sample of individuals in the Medical Expenditure Panel Survey and were adjusted for age, sex, race, ethnicity, income, education and co-morbidity. Resource utilisation was based on experience at the University Medicine Group Practice Anticoagulation Clinic (University of Colorado, Denver, CO, USA) and costs ($US; 2004 values) included were for warfarin and aspirin (acetylsalicylic acid) use and those associated with major bleeding, treatment of primary events, routine INR and biochemistry monitoring, ECGs, and clinic visits. Costs and outcomes were discounted by 3% per annum.

RESULTS

The anticoagulation management service improved effectiveness by 0.057 (95% credible interval 0, 0.36) QALYs and reduced costs by $US2100 (95% credible interval -$US19,800, $US300) [2004 values] compared with usual care. Results were sensitive to the extent of the increase in risk of primary events (all strokes and systemic embolic events attributable to usual care, but were robust to variation in other input variables). The anticoagulation management service was the dominant strategy in 91% of Monte Carlo simulations.

CONCLUSION

The anticoagulation management service appears to cost less and provide greater effectiveness than usual care. To enhance stroke prophylaxis among high-risk patients with atrial fibrillation, physicians and Medicare plans may wish to consider augmenting 'usual care' by the addition of patient-monitoring technology strategies such as formally organised anticoagulation monitoring programmes.

摘要

背景

对于有中风高风险的房颤患者,使用华法林进行抗凝治疗被广泛认为是预防中风的标准治疗方法。美国的社区研究报告称,抗凝治疗的有效性因管理方法而异,接受华法林治疗的患者国际标准化比值(INR)处于目标治疗范围内的时间不到一半。

目的

评估华法林治疗预防中风的终身社会成本和健康效益,特别是对于平均年龄70岁、有中风高风险的老年房颤患者,比较通过常规护理与抗凝管理服务进行抗凝治疗的情况,其中由专门的抗凝专业人员(如医生或药剂师)监测和监督患者。

方法

采用半马尔可夫决策模型,周期长度为30天,时间跨度为10年(以反映研究人群的平均预期寿命)。进行了单因素敏感性分析和使用蒙特卡洛模拟的贝叶斯二阶多变量概率敏感性分析。结果指标为成本和质量调整生命年(QALY)。大多数概率和结果估计值来自最近的SPORTIF(心房颤动中使用口服凝血酶抑制剂预防中风)V试验。效用值来自医疗支出面板调查中具有全国代表性的大样本个体,并根据年龄、性别、种族、民族、收入、教育程度和合并症进行了调整。资源利用基于科罗拉多大学丹佛分校大学医学集团实践抗凝诊所的经验,所包括的成本(以2004年美元价值计)用于华法林和阿司匹林(乙酰水杨酸)的使用以及与大出血、主要事件治疗、常规INR和生化监测、心电图以及门诊就诊相关的成本。成本和结果按每年3%进行贴现。

结果

与常规护理相比,抗凝管理服务使有效性提高了0.057个质量调整生命年(95%可信区间0,0.36),并使成本降低了2100美元(95%可信区间 -19800美元,300美元)[2004年价值]。结果对主要事件风险增加的程度敏感(所有中风和全身栓塞事件归因于常规护理,但对其他输入变量的变化具有稳健性)。在91%的蒙特卡洛模拟中,抗凝管理服务是主导策略。

结论

抗凝管理服务似乎比常规护理成本更低且有效性更高。为了加强对有中风高风险的房颤患者的预防,医生和医疗保险计划可能希望考虑通过增加患者监测技术策略,如正式组织的抗凝监测计划,来加强“常规护理”。

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