阿替利珠单抗联合标准化疗方案治疗广泛期小细胞肺癌的成本-效用分析(1)
摘 要 目的：从卫生体系角度评价阿替利珠单抗联合标准化疗方案对比单用化疗方案一线治疗广泛期小细胞肺癌(ES-SCLC)的经济性。方法：参考一项Ⅲ期临床试验数据(IMpower133研究)及其他文献数据构建ES-SCLC患者分区生存模型，评价阿替利珠单抗联合标准化疗方案(依托泊苷+卡铂)对比单纯化疗方案(依托泊苷+卡铂)一线治疗ES-SCLC的经济性;并采用单因素敏感性分析和概率敏感性分析法评价结果的稳定性。结果：成本-效用分析结果显示，阿替利珠单抗联合化疗组的成本为489 598.52元，效用为0.70 质量调整生命年(QALYs);单纯化疗组的成本为126 276.80元，效用为0.55 QALYs;两组相比的增量成本-效用比(ICUR)为2 361 709.05元/QALY，远超意愿支付阈值(WTP)(即2019年我国3倍人均GDP，212 676元)。单因素敏感性分析结果显示，阿替利珠单抗联合化疗组无进展状态效用值对成本-效用分析结果的影响最大;概率敏感性分析结果提示，在0～500 000 元/QALY的WTP范围内，阿替利珠单抗联合化疗方案始终不具有经济性。结论：阿替利珠单抗联合化疗方案对比单用化疗方案治疗ES-SCLC在我国现有的经济水平下不具有成本-效用优势。
关键词 阿替利珠单抗;化疗;广泛期小细胞肺癌;药物经济学;成本-效用分析
ABSTRACT OBJECTIVE：To evaluate the economics of atezolizumab combined with stardard chemotherapy regimens versus chemotherapy regimens alone as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) from the healthcare system perspective. METHODS： A partitioned survival model was constructed using published phase Ⅲ clinical trial data (IMpower133) and literature data to evaluate the economics of atezolizumaba combined with standard chemotherapy regimens versus chemotherapy regimens alone as first-line treatment for ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the stability of the results. RESULTS： The results of cost-utility analysis showed that the cost of atezolizumab combined with chemotherapy group was 489 598.52 yuan， with utility of 0.70 QALYs;the cost of chemotherapy alone group was 126 276.80 yuan， with utility of 0.55 QALYs; the incremental cost-utility ratio (ICUR) between the two groups was 2 361 709.05 yuan/QALY， far exceeding the willingness-to-pay (WTP) in China (3 times of GDP per capita in 2019， 212 676 yuan). One-way sensitivity analysis showed that progression-free utility value of atezolizumab combined with chemotherapy had the greatest impact on the results of cost-utility analysis; probabilistic sensitivity analysis suggested that the atezolizumab combined with chemotherapy regimen was not economical within the WTP range of 0-500 000 yuan/QALY. CONCLUSIONS：Atezolizumab combined with chemotherapy regimen has no cost-utility advantage versus chemotherapy alone in the first-line treatment of ES-CLC under the current economic level of China.
KEYWORDS Atezolizumab; Chemotherapy; Extensive-stage small-cell lung cancer; Pharmacoeconomics; Cost-utility analysis
肺癌是一種起源于支气管黏膜上皮及肺泡的恶性肿瘤，是我国发病率和病死率最高的恶性肿瘤之一[1-2]。据全国肿瘤登记中心统计数据显示，2014年我国肺癌发病率为57.13/10万，病死率为45.8/10万，且呈逐年增加的趋势[3-6]。小细胞肺癌(Small-cell lung cancer，SCLC)是肺癌的一种亚型，占肺癌的15%～20%[7]，其中70%的SCLC患者为广泛期小细胞肺癌(Extensive-stage SCLC，ES-SCLC)[8]。化疗是临床治疗ES-SCLC的主要手段，常用的一线标准化疗方案为铂类药物联合依托泊苷[1]。尽管一线化疗方案初始缓解率较高，但绝大多数病例复发迅速或易出现药物耐受，导致ES-SCLC患者预后较差，中位生存期仅约为10个月[9-10]。, 百拇医药(刘国强 康朔)
关键词 阿替利珠单抗;化疗;广泛期小细胞肺癌;药物经济学;成本-效用分析
ABSTRACT OBJECTIVE：To evaluate the economics of atezolizumab combined with stardard chemotherapy regimens versus chemotherapy regimens alone as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) from the healthcare system perspective. METHODS： A partitioned survival model was constructed using published phase Ⅲ clinical trial data (IMpower133) and literature data to evaluate the economics of atezolizumaba combined with standard chemotherapy regimens versus chemotherapy regimens alone as first-line treatment for ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the stability of the results. RESULTS： The results of cost-utility analysis showed that the cost of atezolizumab combined with chemotherapy group was 489 598.52 yuan， with utility of 0.70 QALYs;the cost of chemotherapy alone group was 126 276.80 yuan， with utility of 0.55 QALYs; the incremental cost-utility ratio (ICUR) between the two groups was 2 361 709.05 yuan/QALY， far exceeding the willingness-to-pay (WTP) in China (3 times of GDP per capita in 2019， 212 676 yuan). One-way sensitivity analysis showed that progression-free utility value of atezolizumab combined with chemotherapy had the greatest impact on the results of cost-utility analysis; probabilistic sensitivity analysis suggested that the atezolizumab combined with chemotherapy regimen was not economical within the WTP range of 0-500 000 yuan/QALY. CONCLUSIONS：Atezolizumab combined with chemotherapy regimen has no cost-utility advantage versus chemotherapy alone in the first-line treatment of ES-CLC under the current economic level of China.
KEYWORDS Atezolizumab; Chemotherapy; Extensive-stage small-cell lung cancer; Pharmacoeconomics; Cost-utility analysis
肺癌是一種起源于支气管黏膜上皮及肺泡的恶性肿瘤，是我国发病率和病死率最高的恶性肿瘤之一[1-2]。据全国肿瘤登记中心统计数据显示，2014年我国肺癌发病率为57.13/10万，病死率为45.8/10万，且呈逐年增加的趋势[3-6]。小细胞肺癌(Small-cell lung cancer，SCLC)是肺癌的一种亚型，占肺癌的15%～20%[7]，其中70%的SCLC患者为广泛期小细胞肺癌(Extensive-stage SCLC，ES-SCLC)[8]。化疗是临床治疗ES-SCLC的主要手段，常用的一线标准化疗方案为铂类药物联合依托泊苷[1]。尽管一线化疗方案初始缓解率较高，但绝大多数病例复发迅速或易出现药物耐受，导致ES-SCLC患者预后较差，中位生存期仅约为10个月[9-10]。, 百拇医药(刘国强 康朔)