Objective To evaluate the cost-effectiveness of abemaciclib plus fulvestrant as second-line treatment for hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)- negative advanced breast cancer.
Methods From the perspective of Chinese healthcare system, based on the data from the MONARCH 2 clinical trial, a dynamic Markov model was constructed to simulate the lifetime direct medical costs and quality-adjusted life years (QALYs) of patients. Incremental cost-effectiveness ratio (ICER) was used to evaluate the economics of abemaciclib plus fulvestrant and fulvestrant monotherapy for HR+/HER2- advanced breast cancer, and the sensitivity of the results was analyzed.
Results Compared with fulvestrant monotherapy, abemaciclib plus fulvestrant group could bring more health benefits (5.31 QALYs vs. 4.49 QALYs), but the total cost was higher (591 689 yuan vs. 462 183 yuan), and the ICER was 157 934.15 yuan/QALY, which was lower than the threshold of willingness to pay (WTP) based on 3 times per capita gross domestic product (GDP) in 2021. The results of one-way sensitivity analysis showed that parameters such as the health utility value in the progression free survival (PFS) state, the probability of targeted drug therapy in the fulvestrant group, and the probability of chemotherapy in the fulvestrant group had great impacts on the ICER value. The results of probabilistic sensitivity analysis showed that the probability of economic efficiency of abemaciclib plus fulvestrant gradually increased and eventually approached 100% when the WTP threshold exceeded 243 000 yuan per QALY. Abemaciclib plus fulvestrant scheme was a prefered therapeutic schedule.
Conclusion Abemaciclib plus fulvestrant is more economical as a second-line therapy for HR﹢/HER2﹣ advanced breast cancer compared with fulvestrant monotherapy.
1.Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2021, 71(3): 209-249. DOI: 10.3322/caac.21660.
2.Serra F, Lapidari P, Quaquarini E, et al. Palbociclib in metastatic breast cancer: current evidence and real-life data[J]. Drugs Context, 2019, 8: 212579. DOI: 10.7573/dic.212579.
3.国家肿瘤质控中心乳腺癌专家委员会, 中国抗癌协会肿瘤药物临床研究专业委员会. CDK4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性晚期乳腺癌的临床应用共识[J]. 中华肿瘤杂志, 2021, 43(4): 405-413. DOI: 10.3760/cma.j.cn112152-20210113-00045.
4.中华人民共和国国家卫生健康委员会. 乳腺癌诊疗指南(2022年版)[J]. 中国合理用药探索, 2022, 19(10): 26. DOI: 10.3969/j.issn.2096-3327.2022.10.001.
5.Sledge GW, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2 a randomized clinical trial[J]. JAMA Oncol, 2020, 6(1): 116-124. DOI: 10.1001/jamaoncol.2019.4782.
6.Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy[J]. J Clin Oncol, 2017, 35(25): 2875-2884. DOI: 10.1200/JCO.2017.73.7585.
7.周挺, 马爱霞. 生存分析在药物经济学评价Markov模型转移概率计算中的应用[J]. 中国循证医学杂志, 2018, 18(10): 1129-1134. [Zhou T, Ma AX. The survival analysis applied in calculation of markov model transition probability in pharmaceutical evaluation[J]. Chinese Journal of Evidence-Based Medicine, 2018, 18(10): 1129-1134.] DOI: CNKI:SUN:ZZXZ.0.2018-10-023.
8.周挺, 马爱霞, 付露阳. 药物经济学评价Markov模型中转移概率计算的探讨[J]. 中国卫生经济, 2017, 36(12): 40-42. [Zhou T, Ma AX, Fu LY. Discusion on the calculation of Markov model transition probability in pharmacoeconomics evaluation[J]. Chinese Health Economics, 2017, 36(12): 40-42.] DOI: 10.7664/CHE 20171210.
9.国家统计局人口和就业统计司, 编. 中国人口和就业统计年鉴[M]. 北京: 中国统计出版社, 2021: 12.
10.药智数据. 药品中标信息查询[DB/OL]. [2022-09-10]. https://db.yaozh.com/yaopinzhongbiao.
11.Zhou K, Jiang C, Li Q. Cost-effectiveness analysis of pembrolizumab monotherapy and chemotherapy in the non-small-cell lung cancer with different PD-L1 tumor proportion scores[J]. Lung Cancer, 2019, 136: 98-101. DOI: 10.1016/j.lungcan.2019.08.028.
12.Wang H, Zeng C, Li X, et al. Cost-utility of afatinib and gefitinib as first-line treatment for EGFR-mutated advanced non-small-cell lung cancer[J]. Future Oncol, 2019, 15(2): 181-191. DOI: 10.2217/fon-2018-0692.
13.雷玮成, 杜宝萍, 林晓泉, 等. 帕博利珠单抗联合化疗一线治疗晚期非小细胞肺癌的成本-效果分析[J]. 中国医院用药评价与分析, 2020, 20(10): 1208-1211. [Lei WC, Du BP, Lin XQ, et al. Cost-effectiveness analysis on pembrolizumab combined with chemotherapy in the first-line treatment of advanced non-small cell lung cancer[J].Evaluation and Analysis of Drug-Use in Hospitals of China, 2020, 20(10): 1208-1211.] DOI: 10.14009/j.issn. 1672-2124.2020.10.015.
14.Zhang H, Zhang Y, Huang C, et al. Cost-effectiveness analysis of trastuzumab emtansine as second-line therapy for HER2-positive breast cancer in China[J]. Clin Drug Investig, 2021, 41(6): 569-577. DOI: 10.1007/s40261-021-01035-4.
15.中国居民营养与慢性病状况报告(2020年)[J].营养学报, 2020, 42(6): 521.
16.Liu X, Lang Y, Liao Y, et al. Atezolizumab plus chemotherapy vs. chemotherapy in advanced or metastatic triple-negative breast cancer: a cost-effectiveness analysis[J]. Front Public Health, 2021, 9: 756899. DOI: 10.3389/fpubh.2021.756899.
17.刘国恩, 主编. 中国药物经济学评价指南2020[M]. 北京: 中国市场出版社, 2020: 27, 46-47.
18.国家统计局. 中华人民共和国2021年国民经济和社会发展统计公报[N]. 人民日报, 2022-3-1(10).
19.Briggs AH, Weinstein MC, Fenwick EAL, et al. Model parameter estimation and uncertainty analysis: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-6[J]. Med Decis Making, 2012, 32(5): 722-732. DOI: 10.1177/0272989X12458348.
20.贾才凤, 冯章英, 张森, 等. 阿贝西利联合氟维司群二线治疗激素受体阳性的晚期乳腺癌的药物经济学评价[J].中国现代应用药学, 2023, 40(12): 1609-1614. [Jia CF, Feng ZY, Zhang S, et al. Pharmacoeconomic evaluation of abemaciclib in combination with fulvestrant for second-line treatment of hormone receptor-positive advanced breast cancer[J]. Chinese Journal of Modern Applied Pharmacy, 2023, 40(12): 1609-1614.] DOI: 10.13748/j.cnki.issn1007-7693.20222787.
21.Wang Y, Rui M, Guan X, et al. Cost-effectiveness analysis of abemaciclib plus fulvestrant in the second-line treatment of women with HR+/HER2- advanced or metastatic breast cancer: a US payer perspective[J]. Front Med, 2021, 8: 658747. DOI: 10.3389/fmed.2021.658747.