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1.皖南医学院第二附属医院药剂科,安徽 芜湖 241000
2.皖南医学院弋矶山医院临床药学科,安徽 芜湖 241000
药师,硕士。研究方向:临床药学和药事管理。E-mail:550474918@qq.com
主管药师,硕士。研究方向:肿瘤临床药学和药物经济学。E-mail:wuyilai2012@126.com
纸质出版日期:2024-10-30,
收稿日期:2024-04-26,
修回日期:2024-09-22,
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何银梅,李晓,刘晓丽等.戈沙妥珠单抗对比单药化疗后线治疗HR+/HER2-晚期转移性乳腺癌的成本-效用分析 Δ[J].中国药房,2024,35(20):2493-2498.
HE Yinmei,LI Xiao,LIU Xiaoli,et al.Cost-utility analysis of sacituzumab govitecan versus single-agent chemotherapy in the treatment of HR+/HER2- advanced metastatic breast cancer[J].ZHONGGUO YAOFANG,2024,35(20):2493-2498.
何银梅,李晓,刘晓丽等.戈沙妥珠单抗对比单药化疗后线治疗HR+/HER2-晚期转移性乳腺癌的成本-效用分析 Δ[J].中国药房,2024,35(20):2493-2498. DOI: 10.6039/j.issn.1001-0408.2024.20.09.
HE Yinmei,LI Xiao,LIU Xiaoli,et al.Cost-utility analysis of sacituzumab govitecan versus single-agent chemotherapy in the treatment of HR+/HER2- advanced metastatic breast cancer[J].ZHONGGUO YAOFANG,2024,35(20):2493-2498. DOI: 10.6039/j.issn.1001-0408.2024.20.09.
目的
2
评估戈沙妥珠单抗对比单药化疗用于激素受体阳性(HR+)/人表皮生长因子受体2阴性(HER2-)晚期转移性乳腺癌后线治疗的经济性。
方法
2
从中国医疗体系角度,基于TROPiCS-02研究构建分区生存模型评估戈沙妥珠单抗和单药化疗的成本和效用。以1个月为循环周期,研究时限设为10年,年贴现率设为5%,模型产出包括总成本和质量调整生命月(QALM),支付意愿阈值设为2023年我国人均国内生产总值的3倍(22 340元/QALM),通过计算增量成本-效果比(ICER)进行成本-效用分析。运用单因素敏感性分析、概率敏感性分析和情境分析分别评估结果的稳健性,并测算戈沙妥珠单抗具备经济性优势时的价格阈值。
结果
2
与单药化疗相比,戈沙妥珠单抗可使HR+/HER2-晚期转移性乳腺癌患者获得增量效用4.25 QALMs,但需要多花费561 570元,ICER为132 102元/QALM,高于支付意愿阈值。单因素敏感性分析结果显示,戈沙妥珠单抗月均费用对结果影响最大;概率敏感性分析结果显示,戈沙妥珠单抗在支付意愿阈值下具有经济性的概率为0。情境分析结果显示,不同研究时限(5、10、15年)下,本研究结论稳健。戈沙妥珠单抗具备经济性优势时的价格阈值为每180 mg 1 344元。
结论
2
基于中国医疗体系角度,戈沙妥珠单抗在目前价格(每180 mg 8 400元)下,相比单药化疗用于HR+/HER2-晚期转移性乳腺癌患者后线治疗不具有经济性,价格需要大幅下调才能具备经济性优势。
OBJECTIVE
2
To estimate the cost-utility of sacituzumab govitecan (SG) versus single-agent chemotherapy in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced metastatic breast cancer.
METHODS
2
From the perspective of the Chinese medical system, a three-state partitioned survival model was constructed to examine the cost-utility of SG versus single-agent chemotherapy based on TROPiCS-02 trial. The cycle length was set to 1 month, and the time horizon was 10 years. The annual discount was 5%. The model output included total costs and quality adjusted life month (QALM), and incremental cost-effectiveness ratio (ICER) was calculated for cost-utility analysis, by setting willingness-to-pay (WTP) threshold at 3 times gross domestic product (GDP) per capita of China in 2023 (22 340 yuan/QALM). Univariate sensitivity analyses, probability sensitivity analyses, and scenario analyses were performed to evaluate the robustness of the results and calculate the price threshold when SG had economic advantages.
RESULTS
2
SG group gained incremental 4.25 QALM and 561 570 yuan compared with single-agent chemotherapy, which resulted in an ICER of 132 102/QALM that was higher than WTP. The results of the univariate sensitivity analysis showed that the monthly average cost of SG had the greatest impact on the results; the results of probability sensitivity analysis showed that the probability of SG scheme being cost-effective at the WTP threshold was 0. The results of scenario analysis showed that the conclusions of this study were robust under different time horizons (5, 10, 15 years). The price threshold for SG being cost-effective was 1 344 yuan per 180 mg.
CONCLUSIONS
2
Based on the perspective of Chinese medical system, SG appears to be not cost-effective compared with single-agent chemotherapy for HR+/HER2- advanced metastatic breast cancer at the price of 8 400 yuan per 180 mg. A substantial price cut should be taken to be cost-effective.
戈沙妥珠单抗成本-效用分析HR+/HER2-晚期转移性乳腺癌分区生存模型药物经济学
cost-utility analysisHR+/HER2- advanced metastatic breast cancerpartitioned survival modelpharmacoeconomics
BRAY F,LAVERSANNE M,SUNG H,et al. Global cancer statistics 2022:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin,2024,74(3):229-263.
GARRIDO-CASTRO A C,LIN N U,POLYAK K. Insights into molecular classifications of triple-negative breast cancer:improving patient selection for treatment[J]. Cancer Discov,2019,9(2):176-198.
GOLDENBERG D M,CARDILLO T M,GOVINDAN S V,et al. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan(IMMU-132),an antibody-drug conjugate(ADC)[J]. Oncotarget,2015,6(26):22496-22512.
RUGO H S,BARDIA A,MARMÉ F,et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer[J]. J Clin Oncol,2022,40(29):3365-3376.
WU Y L,HU S S,LIU X L,et al. Cost-effectiveness of sacituzumab govitecan versus single-agent chemotherapy for metastatic triple-negative breast cancer:a trial-based analysis[J]. Cost Eff Resour Alloc,2024,22(1):32.
刘国恩. 中国药物经济学评价指南2020[M]. 北京:中国市场出版社,2020:36-46.
LIU G E. Chinese pharmacoeconomic evaluation guidelines 2020[M]. Beijing:China Market Publishing House,2020:36-46.
HAGIWARA Y,OHASHI Y,UESAKA K,et al. Health-related quality of life of adjuvant chemotherapy with S-1 versus gemcitabine for resected pancreatic cancer:results from a randomised phase Ⅲ trial(JASPAC 01)[J]. Eur J Cancer,2018,93:79-88.
GUYOT P,ADES A E,OUWENS M J,et al. Enhanced secondary analysis of survival data:reconstructing the data from published Kaplan-Meier survival curves[J]. BMC Med Res Methodol,2012,12:9.
WOODS B S,SIDERIS E,PALMER S,et al. Partitioned survival and state transition models for healthcare decision making in oncology:where are we now?[J]. Value Health,2020,23(12):1613-1621.
RAUTENBERG T,HODGKINSON B,ZERWES U,et al. Meta-analysis of health state utility values measured by EuroQol 5-dimensions(EQ-5D)questionnaire in Chinese women with breast cancer[J]. BMC Cancer,2022,22(1):52.
中国临床肿瘤学会. 肿瘤放化疗相关中性粒细胞减少症规范化管理指南[J]. 中华肿瘤杂志,2017,39(11):868-878.
Chinese Society of Clinical Oncology. Guidelines for standardized management of neutropenia induced by chemotherapy and radiotherapy[J]. Chin J Oncol,2017,39(11):868-878.
DRANITSARIS G,YU B,KING J,et al. Nab-paclitaxel,docetaxel,or solvent-based paclitaxel in metastatic breast cancer:a cost-utility analysis from a Chinese health care perspective[J]. Clinicoecon Outcomes Res,2015,7:249-256.
LI J B,JIANG Z F. Chinese Society of Clinical Oncology Breast Cancer(CSCO BC)guidelines in 2022:stratification and classification[J]. Cancer Biol Med,2022,19(6):769-773.
WU B,ZHANG Q,SUN J. Cost-effectiveness of nivolumab plus ipilimumab as first-line therapy in advanced renal-cell carcinoma[J]. J Immunother Cancer,2018,6(1):124.
LOIBL S,LOIRAT D,TOLANEY S M,et al. Health-related quality of life in the phase Ⅲ ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer[J]. Eur J Cancer,2023,178:23-33.
胡善联. 中国医保药品价格谈判回顾和展望[J]. 卫生经济研究,2024,41(1):9-13.
HU S L. Review and prospects of medical insurance price negotiation in China[J]. Health Econ Res,2024,41(1):9-13.
SHI D M,LI Y,LIANG X Y,et al. Cost-effectiveness of sacituzumab govitecan in hormone receptor-positive/ human epidermal growth factor receptor 2-negative metastatic breast cancer[J]. Front Oncol,2023,13:1162360.
LANG Y T,CHAI Q Q,TAO W Q,et al. Cost-effectiveness of sacituzumab govitecan versus chemotherapy in advanced or metastatic triple-negative breast cancer[J]. Breast,2023,68:173-180.
CHEN J G,HAN M Y,LIU A H,et al. Economic evaluation of sacituzumab govitecan for the treatment of metastatic triple-negative breast cancer in China and the US[J]. Front Oncol,2021,11:734594.
XIE J,LI S N,LI Y M,et al. Cost-effectiveness of sacituzumab govitecan versus chemotherapy in patients with relapsed or refractory metastatic triple-negative breast cancer[J]. BMC Health Serv Res,2023,23(1):706.
CHER B P,GOH S,AZIZ M I A,et al. Cost-utility analysis of sacituzumab govitecan versus chemotherapy for the treatment of metastatic triple-negative breast cancer in Singapore[J]. Expert Rev Pharmacoecon Outcomes Res,2024,24(2):217-225.
WAN X M,PENG L B,LI Y J. A review and comparison of methods for recreating individual patient data from published Kaplan-Meier survival curves for economic evaluations:a simulation study[J]. PLoS One,2015,10(3):e0121353.
XU B H,MA F,WANG T,et al. A phase Ⅱb,single arm,multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments[J]. Int J Cancer,2023,152(10):2134-2144.
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