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唑来膦酸在法国、德国、葡萄牙和荷兰激素难治性前列腺癌患者骨骼转移管理中的成本效益。

Cost effectiveness of zoledronic acid in the management of skeletal metastases in hormone-refractory prostate cancer patients in France, Germany, Portugal, and the Netherlands.

机构信息

Pharmerit International-Health Economics, Pharmerit North America LLC, 7272 Wisconsin Ave. #300, Bethesda, MD, USA.

出版信息

J Med Econ. 2011;14(3):288-98. doi: 10.3111/13696998.2011.570170. Epub 2011 Apr 6.

Abstract

OBJECTIVE

Zoledronic acid (ZOL) reduces the risk of skeletal related events (SREs) in hormone-refractory prostate cancer (HRPC) patients with bone metastases. This study assessed the cost effectiveness of ZOL for SRE management in French, German, Portuguese, and Dutch HRPC patients.

METHODS

This analysis was based on the results of a randomized phase III clinical trial wherein HRPC patients received up to 15 months of ZOL (n = 214) or placebo (n = 208). Clinical inputs were obtained from the trial. Costs were estimated using hospital tariffs, published, and internet sources. Quality adjusted life-years (QALYs) gained were estimated from a separate analysis of EQ-5D scores reported in the trial. Uncertainty surrounding outcomes was addressed via univariate sensitivity analyses.

RESULTS

ZOL patients experienced an estimated 0.759 fewer SREs and gained an estimated 0.03566 QALYs versus placebo patients. ZOL was associated with reduced SRE-related costs [net costs] (-€2396 [€1284] in France, -€2606 [€841] in Germany, -€3326 [€309] in Portugal and -€3617 [€87] in the Netherlands). Costs per QALY ranged from €2430 (Netherlands) to €36,007 (France).

CONCLUSIONS

This analysis is subject to the limitations of most cost-effectiveness analyses: it combines data from multiple sources. Nevertheless, the results strongly suggest that ZOL is cost effective versus placebo in French, German, Portuguese, and Dutch HRPC patients.

摘要

目的

唑来膦酸(zoledronic acid,ZOL)可降低伴有骨转移的激素难治性前列腺癌(hormone-refractory prostate cancer,HRPC)患者发生骨骼相关事件(skeletal-related events,SREs)的风险。本研究评估了 ZOL 用于法国、德国、葡萄牙和荷兰 HRPC 患者 SRE 管理的成本效果。

方法

该分析基于一项随机 III 期临床试验的结果,其中 HRPC 患者接受了长达 15 个月的 ZOL(n=214)或安慰剂(n=208)治疗。临床数据来源于该试验。成本采用医院收费标准、已发表文献和互联网资源进行估算。效用值(quality adjusted life-years,QALYs)的增益则根据试验中报告的 EQ-5D 评分的单独分析进行估算。通过单变量敏感性分析解决了结果的不确定性。

结果

ZOL 组患者预计发生 SRE 的次数比安慰剂组少 0.759 次,预计获得的 QALY 增益为 0.03566。与安慰剂组相比,ZOL 组 SRE 相关成本降低[净成本](法国-2396 欧元[1284 美元],德国-2606 欧元[841 美元],葡萄牙-3326 欧元[309 美元],荷兰-3617 欧元[87 美元])。每个 QALY 的成本范围从荷兰的 2430 欧元到法国的 36007 欧元。

结论

本分析受大多数成本效果分析的限制:它结合了来自多个来源的数据。尽管如此,结果强烈表明,与安慰剂相比,ZOL 在法国、德国、葡萄牙和荷兰的 HRPC 患者中具有成本效果。

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