邓小莹,周晓虹,陈洁,李国豪
DENG Xiaoying,ZHOU Xiaohong,CHEN Jie,LI Guohao

• 1:广州市第一人民医院

摘要(Abstract)：

目的对两种乳腺癌辅助治疗方案:AC-T方案(多柔比星+环磷酰胺-多西他赛)、AC-TH方案(多柔比星+环磷酰胺-曲妥珠单抗+多西他赛)进行药物经济学评价。方法根据疾病稳定、疾病缓解、疾病进展和死亡4种状态,建立马尔可夫(Markov)模型,以广州市某三甲医院的收费标准确定两种方案的总成本,进行成本效果分析,并对结果进行敏感度分析,发现最优方案。结果 AC-T方案和AC-TH方案的治疗总成本分别为92 490.03元及409 271.85元;两种方案所获得的生命质量调整年(QALYs)分别为11.45 QALYs及14.28 QALYs;联用曲妥珠单抗后的增量成本效果比(ICER)为111 937.04元/QALY。敏感度分析结果稳定,不影响模型分析结构。结论 AC-TH方案与AC-T方案相比,ICER超过支付意愿,从成本效果分析看来,AC-TH方案为优选方案。
OBJECTIVE To perform a pharmacoeconomic evaluation of Trastuzumab in adjuvant treatment for early breast cancer.METHODS Built a Markov state transition model to simulate the dynamic changes of the four disease states( including stable disease,disease remission,disease progression and death) in patients who received AC-T therapy or AC-TH therapy with early breast cancer. The costs of these two therapies were calculated according to the charging standard of a third-level grade-A hospital in Guangzhou city.One way sensitivity analysis was carried out then. RESULTS The costs of AC-T therapy and AC-TH therapy were 92 490.03 Yuan and 409 271.85 Yuan,respectively.The model showed that quality-adjusted life-years( QALYs) of AC-T therapy and AC-TH therapy were 11.45 QALYs、14.28 QALYs,respectively. An incremental cost-effectiveness ratio( ICER) of 111 937. 04 Yuan/QALY gained. CONCLUSION Compare with AC-T therapy,the ICER of AC-TH therapy is out of pay,but as to cost-effectiveness analysis,AC-TH therapy is the preferred option.

关键词(KeyWords)： 乳腺癌;曲妥珠单抗;马尔可夫模型;成本效果分析
breast cancer;trastuzumab;Markov model;cost-effectiveness analysis

Abstract:

Keywords:

基金项目(Foundation): 广州市医药卫生科技项目(20141A010011);; 广东省医院药学研究基金(2015A07)

作者(Author): 邓小莹,周晓虹,陈洁,李国豪
DENG Xiaoying,ZHOU Xiaohong,CHEN Jie,LI Guohao

参考文献(References)：

• [1]Fan L,Strasser-Weippl K,Li J J,et al.Breast cancer in China[J].Lancet Oncology,2014,15(7):279-289.
• [2]Slamon D J,Leyland-Jones B,Shak S,et al.Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2[J].N Engl J Med,2001,344(11):783-792.
• [3]Slamon D,Eiermann W,Robert N,et al.Adjuvant trastuzumab in HER2-positive breast cancer[J].N Engl J Med,2011,365(14):1273-1283.
• [4]Piccart-Gebhart M J,Procter M,Leyland-Jones B,et al.Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer[J].N Engl J Med,2005,353(16):1659-1672.
• [5]Joensuu H,Kellokumpu-Lehtinen P L,Bono P,et al.Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer[J].N Engl J Med,2006,354(8):809-820.
• [6]Shen J,Hunt K K,Mirza N Q,et al.Predictors of systemic recurrence and disease-specific survival after ipsilateral breast tumor recurrence[J].Cancer,2005,104(3):479-490.
• [7]Harris E E,Hwang W T,Seyednejad F,et al.Prognosis after regional lymph node recurrence in patients with stage I-II breast carcinoma treated with breast conservation therapy[J].Cancer,2003,98(10):2144-2151.
• [8]Early Breost Cancer Trialists'Collaboratiue Group.Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival:an overview of the randomised trials[J].Lancet,2005,365(9472):1687-1717.
• [9]Beck J R,Kassirer J P,Pauker S G.A convenient approximation of life expectancy(the"DEALE").I.Validation of the method[J].Am J Med,1982,73(6):883-888.
• [10]Beck J R,Pauker S G,Gottlieb J E,et al.A convenient approximation of life expectancy(the"DEALE").II.Use in medical decision-making[J].Am J Med,1982,73(6):889-897.
• [11]中国药物经济学评价指南课题组.中国药物经济学评价指南(2011版)[J].中国药物经济学,2011,6(3):6-9.
• [12]Zhou B F.Predictive values of body mass index and waist circumference for risk factors of certain related diseases in Chinese adults--study on optimal cut-off points of body mass index and waist circumference in Chinese adults[J].Biomed Environ Sci,2002,15(1):83-96.
• [13]王思颖,彭六保,曾小慧,等.Markov模型应用于药物经济学中效用值的计算及实例分析[J].中国药房,2012,23(18):1653-1656.
• [14]Garrison L J,Veenstra D L.The economic value of innovative treatments over the product life cycle:the case of targeted trastuzumab therapy for breast cancer[J].Value Health,2009,12(8):1118-1123.
• [15]Millar J A,Millward M J.Cost effectiveness of trastuzumab in the adjuvant treatment of early breast cancer:a lifetime model[J].Pharmacoeconomics,2007,25(5):429-442.
• [16]Mckeage K,Lyseng-Williamson K A.Trastuzumab:a pharmacoeconomic review of its use in early breast cancer[J].Pharmacoeconomics,2008,26(8):699-719.
• [17]Purmonen T T,Pankalainen E,Turunen J H,et al.Short-course adjuvant trastuzumab therapy in early stage breast cancer in Finland:cost-effectiveness and value of information analysis based on the 5-year follow-up results of the Fin Her Trial[J].Acta Oncol,2011,50(3):344-352.
• [18]Van Vlaenderen I,Canon J L,Cocquyt V,et al.Trastuzumab treatment of early stage breast cancer is cost-effective from the perspective of the Belgian health care authorities[J].Acta Clin Belg,2009,64(2):100-112.
• [19]Buendia J A,Vallejos C,Pichon-Riviere A.An economic evaluation of trastuzumab as adjuvant treatment of early HER2-positive breast cancer patients in Colombia[J].Biomedica,2013,33(3):411-417.