Shiroiwa Takeru, Fukuda Takashi, Shimozuma Kojiro, Ohashi Yasuo, Tsutani Kiichiro
Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
Pharmacoeconomics. 2009;27(7):597-608. doi: 10.2165/11310110-000000000-00000.
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.
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.
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.
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.
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。
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。
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。
该分析表明,在日本,当卡培他滨作为Ⅲ期结肠癌患者的辅助治疗时,与推注FU/LV相比,它能改善健康结局并降低直接成本(即优势治疗策略)。