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每周使用促红细胞生成素α与每两周使用达贝泊汀α治疗化疗所致贫血的经济学评估:一项16周随机试验的证据

Economic evaluation of weekly epoetin alfa versus biweekly darbepoetin alfa for chemotherapy-induced anaemia: evidence from a 16-week randomised trial.

作者信息

Reed Shelby D, Radeva Jasmina I, Daniel Davey B, Mody Samir H, Forlenza Jamie B, McKenzie R Scott, Schulman Kevin A

机构信息

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27715, USA.

出版信息

Pharmacoeconomics. 2006;24(5):479-94. doi: 10.2165/00019053-200624050-00006.

Abstract

INTRODUCTION

A 16-week, open-label, multicentre, randomised trial of weekly epoetin alfa 40 000 units versus biweekly darbepoetin alfa 200microg among 358 patients with solid-tumour cancers and chemotherapy-induced anaemia demonstrated superior haematological outcomes with epoetin alfa. We sought to compare resource use, costs and clinical outcomes between treatment groups and report the results using a cost-consequences framework.

METHODS

Pre-specified methods were used to assign costs (US dollars, year 2004-5 values) to medical resources and patient time using a societal perspective. Costs for inpatient care, outpatient care and physician services were based on US Medicare reimbursement rates. Indirect costs assigned to patient time spent receiving study medication were based on the mean hourly wage in the US. In the base-case analysis, the average wholesale price was used to assign costs to medications. Clinical outcomes included all haemoglobin levels and transfusions recorded throughout the trial. Sensitivity analyses were performed to evaluate the impact of different costing methods, cost sources, perspectives and methods to assign haemoglobin values following a blood transfusion.

RESULTS

Over a mean follow-up duration of 11.8 weeks, the average cost of study medications and their administration was the single largest component of total costs and was similar between groups (epoetin alfa 5979 US dollars and darbepoetin alfa 5935 US dollars, difference 44 US dollars; 95% CI -590, 692). There were no significant differences in the proportions of patients hospitalised (epoetin alfa 24.6%, darbepoetin alfa 22.0%; p = 0.57). Patients randomised to epoetin alfa experienced more inpatient days, on average, than patients randomised to darbepoetin alfa (2.6 vs 1.6, 95% CI for the difference, 0.07, 2.27). However, with regard to transfusions, patients in the epoetin alfa arm required fewer units of blood than patients in the darbepoetin alfa arm (0.46 vs 0.88, 95% CI for the difference -0.77, -0.08). Mean total costs, comprising costs for study medications and their administration, inpatient care, transfusions, unplanned radiation therapy, haematology and laboratory services, chemotherapy and non-chemotherapy drugs and indirect costs were 14,976 US dollars in the epoetin alfa arm compared with 14,101 US dollars in the darbepoetin alfa arm, a difference of 875 US dollars (95% CI for difference -849, 2607), of which 98% of the difference was attributable to higher inpatient costs in the epoetin alfa arm (2374 US dollars vs 1520 US dollars; 95% CI for difference -33, 1955). Assessments of multiple clinical measures demonstrated improved outcomes with epoetin alfa relative to darbepoetin alfa.

CONCLUSION

Most clinical outcome measures suggested greater improvement with epoetin alfa relative to darbepoetin alfa, but most costs for both agents appeared similar. Decision makers must evaluate the differences in costs and efficacy measures that are most relevant from their perspectives.

摘要

引言

一项针对358例实体肿瘤癌症及化疗所致贫血患者的为期16周的开放标签、多中心随机试验,比较了每周一次注射40000单位促红细胞生成素α与每两周一次注射200μg达贝泊汀α的疗效,结果显示促红细胞生成素α的血液学疗效更佳。我们试图比较治疗组之间的资源使用、成本和临床结局,并使用成本 - 后果框架报告结果。

方法

采用预先设定的方法,从社会角度为医疗资源和患者时间分配成本(美元,2004 - 2005年价值)。住院护理、门诊护理和医生服务的成本基于美国医疗保险报销率。分配给患者接受研究药物治疗时间的间接成本基于美国平均时薪。在基础病例分析中,使用平均批发价格为药物分配成本。临床结局包括整个试验期间记录的所有血红蛋白水平和输血情况。进行敏感性分析以评估不同成本计算方法、成本来源、视角以及输血后血红蛋白值分配方法的影响。

结果

在平均11.8周的随访期内,研究药物及其给药的平均成本是总成本中最大的单一组成部分,两组之间相似(促红细胞生成素α为5979美元,达贝泊汀α为5935美元,差值44美元;95%可信区间 -590, 692)。住院患者比例无显著差异(促红细胞生成素α为24.6%,达贝泊汀α为22.0%;p = 0.57)。随机接受促红细胞生成素α治疗的患者平均住院天数比随机接受达贝泊汀α治疗的患者多(2.6天对1.6天,差值的95%可信区间为0.07, 2.27)。然而,在输血方面,促红细胞生成素α组患者所需的血液单位数比达贝泊汀α组患者少(0.46对0.88,差值的95%可信区间为 -0.77, -0.08)。促红细胞生成素α组的平均总成本,包括研究药物及其给药、住院护理、输血、计划外放射治疗、血液学和实验室服务、化疗及非化疗药物以及间接成本,为14976美元,而达贝泊汀α组为14101美元,差值为875美元(差值的95%可信区间为 -849, 2607),其中98%的差值归因于促红细胞生成素α组较高的住院成本(2374美元对1520美元;差值的95%可信区间为 -33, 1955)。对多种临床指标的评估表明,与达贝泊汀α相比,促红细胞生成素α的结局有所改善。

结论

大多数临床结局指标表明,与达贝泊汀α相比,促红细胞生成素α的改善更大,但两种药物的大多数成本似乎相似。决策者必须从自身角度评估最相关的成本和疗效指标差异。

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