达沙替尼治疗伊马替尼耐药的慢性粒细胞白血病的药物经济学评价

Pharmacoeconomic Evaluation of Dasatinib in the Treatment of Imatinib-resistant Chronic Myelocytic Leukemia

目的:综合考虑达沙替尼和大剂量伊马替尼在治疗伊马替尼耐药的慢性粒细胞白血病(CML)慢性期患者时的健康产出、不良反应及治疗成本,分析哪种用药方案更具经济性,为医保谈判和临床药物遴选提供决策依据。方法:通过文献研究法、专家咨询法获得相关药物临床试验及不良反应信息,结合国内相关药物及不良反应治疗成本,利用Treeage软件构建Markov模型并通过队列分析法和Monte Carlo模拟分别计算两种方案靶向治疗CML5、10、20、30年的疾病转归、健康产出及成本消耗,通过成本-效用分析对伊马替尼产生耐药的CML患者的两种用药方案进行药物经济学评价。结果:贴现率设定为3%且假定患者连续用药30年时,队列分析法与Monte Carlo模拟计算出达沙替尼组的成本-效用比分别为38 881.74元/质量调整生存月(QALM)、40 096.06元/QALM;大剂量伊马替尼组成本-效用比分别为53 844.15元/QALM、55 500.70元/QALM,且无论模拟时间和贴现率如何变化,达沙替尼均为优势药物。敏感度分析结果显示,达沙替尼更具经济性优势。结论:对伊马替尼耐药的CML慢性期患者改用达沙替尼比加大伊马替尼剂量进行治疗更具有较好的经济性。

To consider about health outcomes, ADR and treatment costs of dasatinib and high dose of imatinib in the treatment of imatinib-resistant chronic myelocytic leukaemia （CML）, and to analyze which project＇s economy was better so as to provide decision-making basis for medical insurance negotiations and clinical drugs selection. METHODS： The relevant clini- cal drug trials and ADR information were collected by means of literature study and expert consultation method; combined with domestic related drugs and treatment costs of ADR, Markov model was established by using Treeage software, and disease pro- gression, health outcomes and cost consumption of 2 treatment schemes were calculated for targeted treatment of CML for 5, 10, 20 and 30 years by means of the queue analysis and Monte Carlo simulations. At last, pharmacoeconomics evaluation was con- ducted by means of cost-effectiveness analysis for 2 treatment schemes in the treatment of imatinib-resistant CML. RESULTS： The results showed that the cost-utility ratio which calculated by queue analysis and Monte Carlo simulation for dasatinib group were 38 881.74 yuan/QALM and 40 096.06 yuan/QALM, respectively; and the cost-utility ratio which calculated by these two methods for imatinib high-dose group were 53 844.15 yuan/QALM and 55 500.70 yuan/QALM respectively when discounted rate was set as 3 % and the time of continuous medication was assumed to be 30 years. No matter how the simulation time and the dis- count rate changed, Dsatinib still was the dominant drug. Result of sensitivity analysis showed it was reliable that dasatinib had su- periorities in economy. CONCLUSIONS： The economy of dasatinib is better than that of high dose of imatinib in the treatment of CML in imatinib-resistant patients.