在日本，卡培他滨与推注5-氟尿嘧啶/亚叶酸钙用于结肠癌辅助治疗的成本效益分析。

Cost-effectiveness analysis of capecitabine compared with bolus 5-fluorouracil/l-leucovorin for the adjuvant treatment of colon cancer in Japan.

作者信息

Shiroiwa Takeru, Fukuda Takashi, Shimozuma Kojiro, Ohashi Yasuo, Tsutani Kiichiro

机构信息

Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.

出版信息

Pharmacoeconomics. 2009;27(7):597-608. doi: 10.2165/11310110-000000000-00000.

DOI:10.2165/11310110-000000000-00000

PMID:19663530

Abstract

OBJECTIVE

A cost-effectiveness analysis of oral capecitabine versus intravenous bolus 5-fluorouracil/l-leucovorin (FU/LV) as adjuvant therapy in patients with stage 3 colon cancer was performed from a Japanese healthcare payer perspective.

METHODS

Adjuvant therapy comprised 24 weeks of treatment with either oral capecitabine 1250 mg/m(2) twice daily on days 1-14 of a 21-day cycle or intravenous bolus FU 500 mg/m(2) and LV 250 mg/m(2) weekly for 6 weeks of an 8-week cycle (Roswell Park regimen). The analysis comprised short-term (1 year after initiation of adjuvant therapy) and long-term (up to 15 years) components. The long-term analysis involved a three-state (disease-free, recurrence and death) Markov model. Estimates for transition probabilities, costs and utilities were derived from the X-ACT trial, a Japanese phase II trial, and other published sources. Cost estimates were considered from the perspective of a healthcare payer. Costs were expressed in Japanese Yen (yen), year 2007 values. A discount rate of 3% was applied to costs and outcomes. Cost effectiveness was expressed as a cost per QALY. The effects of uncertainty were explored through one-way and probabilistic sensitivity analyses.

RESULTS

In the 1-year analysis, direct costs were yen440,000 ($US4000) less per patient with capecitabine than with FU/LV. In the long-term analysis, differences between treatments in direct medical costs ranged from yen470,000 ($US4300) to yen580,000 ($US5300) depending on the time horizon used. Capecitabine was also projected to increase the number of QALYs compared with FU/LV. The sensitivity analysis suggested that the model outcome was robust. The probabilistic sensitivity analysis estimate of capecitabine being the dominant regimen was 96.6% at a zero willingness to pay. Direct costs remained lower with capecitabine if the price of generic LV was >OR=50% of the branded product.

CONCLUSION

This analysis suggests that capecitabine improves health outcomes and lowers direct costs compared with bolus FU/LV (i.e. dominant treatment strategy) when used as adjuvant therapy in patients with stage 3 colon cancer in Japan.

摘要

目的

从日本医疗支付方的角度，对口服卡培他滨与静脉推注5-氟尿嘧啶/亚叶酸钙（FU/LV）作为Ⅲ期结肠癌患者辅助治疗的成本效益进行分析。

方法

辅助治疗包括在21天周期的第1 - 14天，每日2次口服卡培他滨1250 mg/m²，共24周；或在8周周期的6周内，每周静脉推注FU 500 mg/m²和LV 250 mg/m²（罗斯韦尔公园方案）。分析包括短期（辅助治疗开始后1年）和长期（长达15年）两个部分。长期分析采用三状态（无病、复发和死亡）马尔可夫模型。转移概率、成本和效用的估计值来自日本II期试验X-ACT试验及其他已发表的资料。成本估计是从医疗支付方的角度进行的。成本以2007年日元表示。成本和结果均采用3%的贴现率。成本效益以每质量调整生命年（QALY）的成本表示。通过单因素和概率敏感性分析探讨不确定性的影响。

结果

在1年分析中，卡培他滨组每位患者的直接成本比FU/LV组少440,000日元（4000美元）。在长期分析中，根据所采用的时间范围，两种治疗方法的直接医疗成本差异在470,000日元（4300美元）至580,000日元（5300美元）之间。与FU/LV相比，卡培他滨预计也会增加QALY的数量。敏感性分析表明模型结果具有稳健性。在支付意愿为零时，卡培他滨作为优势方案的概率敏感性分析估计值为96.6%。如果普通LV的价格≥品牌产品价格的50%，卡培他滨的直接成本仍然较低。