Pharmacoeconomic evaluation of trastuzumab biosimilars versus original drug in the treatment of recurrent/metastatic HER-2 positive breast cancer

XING Yue; LIU Tong; TENG Xue; DONG Mei

doi:10.6039/j.issn.1001-0408.2024.09.15

您当前的位置：

首页 >

文章列表页 >

Pharmacoeconomic evaluation of trastuzumab biosimilars versus original drug in the treatment of recurrent/metastatic HER-2 positive breast cancer

更新时间：2025-09-25

- Pharmacoeconomic evaluation of trastuzumab biosimilars versus original drug in the treatment of recurrent/metastatic HER-2 positive breast cancer
- ZHONGGUO YAOFANG Vol. 35, Issue 9, Pages: 1113-1117(2024)
- 作者机构：
  
  哈尔滨医科大学附属肿瘤医院药学部，哈尔滨　150081
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.09.15
  CLC： R956;R979.1
- Received：27 October 2023，
  
  Revised：2024-04-15，
  
  Accepted：15 April 2024，
  
  Published：15 May 2024
- 稿件说明：
移动端阅览
邢玥,刘通,滕雪,等.曲妥珠单抗生物仿制药对比原研药治疗复发或转移性HER-2阳性乳腺癌的药物经济学评价[J].中国药房,2024,35(09):1113-1117.

XING Yue,LIU Tong,TENG Xue,et al.Pharmacoeconomic evaluation of trastuzumab biosimilars versus original drug in the treatment of recurrent/metastatic HER-2 positive breast cancer[J].ZHONGGUO YAOFANG,2024,35(09):1113-1117.
邢玥,刘通,滕雪,等.曲妥珠单抗生物仿制药对比原研药治疗复发或转移性HER-2阳性乳腺癌的药物经济学评价[J].中国药房,2024,35(09):1113-1117. DOI： 10.6039/j.issn.1001-0408.2024.09.15.

XING Yue,LIU Tong,TENG Xue,et al.Pharmacoeconomic evaluation of trastuzumab biosimilars versus original drug in the treatment of recurrent/metastatic HER-2 positive breast cancer[J].ZHONGGUO YAOFANG,2024,35(09):1113-1117. DOI： 10.6039/j.issn.1001-0408.2024.09.15.

摘要

目的

从卫生体系角度评估曲妥珠单抗生物仿制药（汉曲优）与原研药（赫赛汀）治疗复发或转移性人表皮生长因子受体2（HER-2）阳性乳腺癌的经济性。

方法

根据NCT03084237试验数据构建分区生存模型，模拟周期为3周，模拟时限为10年。以成本和质量调整生命年（QALY）为产出指标，采用成本-效用分析法评价上述2种方案的经济性。采用单因素敏感性分析和概率敏感性分析检验模型的稳健性。

结果

曲妥珠单抗生物仿制药组与原研药组的成本分别为111 516.72、111 122.30元，效用分别为1.52、1.36 QALYs，增量成本-效果比（ICER）为2 465.12元/QALY，小于以3倍中国2023年人均国内生产总值（GDP）作为的意愿支付（WTP）阈值（268 200元/QALY）。单因素敏感性分析结果表明，曲妥珠单抗生物仿制药费用与曲妥珠单抗原研药费用对ICER有较大影响。概率敏感性分析结果显示，当WTP阈值大于14 902元/QALY时，曲妥珠单抗生物仿制药组具有经济性的概率为100%。

结论

当WTP阈值为3倍中国2023年人均GDP（268 200元/QALY）时，与曲妥珠单抗原研药相比，曲妥珠单抗生物仿制药治疗复发或转移性HER-2阳性乳腺癌具有较好的经济性。

Abstract

OBJECTIVE

To evaluate the cost-effectiveness of trastuzumab biosimilars （Hanquyou） versus original drug （Hesaiting） in the treatment of recurrent/metastatic human epidermal growth factor receptor-2 （HER-2） positive breast cancer.

METHODS

A partitional survival model was constructed based on the NCT03084237 trial data. The simulation period was 3 weeks， and the simulation time was 10 years. Using costs and quality-adjusted life year （QALY） as the output indicator， the cost-utility analysis method was used to evaluate the cost-effectiveness of the two schemes mentioned above. Univariate and probabilistic sensitivity analyses were performed to verify the robustness of the basic analysis.

RESULTS

The costs of the trastuzumab biosimilars group and original drug group were 111 516.72 yuan and 111 122.30 yuan respectively， with health utility values of 1.52 QALYs and 1.36 QALYs， and ICER of 2 465.12 yuan/QALY， which were less than 3 times China’s per capita gross domestic product （GDP） in 2023 as the threshold for willingness-to-pay （WTP）（268 200 yuan/QALY）. Univariate sensitivity analysis showed that the cost of the trastuzumab biosimilars and original drug had a great impact on the ICER. The probabilistic sensitivity analysis showed that the probability of trastuzumab biosimilars being cost-effective was 100% at WTP threshold of 14 902 yuan/QALY.

CONCLUSIONS

When WTP threshold is 3 times China’s GDP in 2023 （268 200 yuan/QALY）， compared with original drug， trastuzumab biosimilars have good cost-effectiveness in the treatment of recurrent/metastatic HER-2 positive breast cancer.

关键词

Keywords

references

SUNG H ， FERLAY J ， SIEGEL R L ， 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 .

郑荣寿，陈茹，韩冰峰，等 . 2022年中国恶性肿瘤流行情况分析 [J ] . 中华肿瘤杂志， 2024 ， 46 （ 3 ）： 221 - 231 .

ZHENG R S ， CHEN R ， HAN B F ， et al . Cancer incidence and mortality in China，2022 [J ] . Chin J Oncol ， 2024 ， 46 （ 3 ）： 221 - 231 .

耿亚迪，刘含韵，吴颖其，等 . 基于真实世界数据分析马来酸吡咯替尼治疗HER-2阳性转移性乳腺癌的有效性及经济性 [J/OL ] . 中国医院药学杂志， 2024 ： 1 - 8 [ 2024-03-07 ] . https：//kns.cnki.net/kcms/detail/42.1204.r.20240305.0913.002.html https://kns.cnki.net/kcms/detail/42.1204.r.20240305.0913.002.html .

GENG Y D ， LIU H Y ， WU Y Q ， et al . Efficacy and pharmacoeconomic evaluation of pyrotinib in the treatment of HER-2 positive metastatic breast cancer based on real-world data [J/OL ] . Chin J Hosp Pharm ， 2024 ： 1 - 8 [ 2024-03-07 ] . https：//kns.cnki.net/kcms/detail/42.1204.r.20240305.0913.002.html https://kns.cnki.net/kcms/detail/42.1204.r.20240305.0913.002.html .

SAROSIEK T ， MORAWSKI P . Trastuzumab and its bio- similars [J ] . Pol Merkur Lekarski ， 2018 ， 44 （ 263 ）： 253 - 257 .

VON MINCKWITZ G ， HUANG C S ， MANO M S ， et al . Trastuzumab emtansine for residual invasive HER2-positive breast cancer [J ] . N Engl J Med ， 2019 ， 380 （ 7 ）： 617 - 628 .

金叶，么乃琦，刘芳 . 曲妥珠单抗应用于乳腺癌治疗中的效果分析 [J ] . 中外女性健康研究， 2022 （ 19 ）： 84 - 85 .

JIN Y ， MO N Q ， LIU F . Analysis of the effect of trastuzumab in the treatment of breast cancer [J ] . Chin Foreign Women Health Res ， 2022 （ 19 ）： 84 - 85 .

STEBBING J ， BARANAU Y V ， BARYASH V ， et al . Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer：final results from a randomized phase Ⅲ trial [J ] . Breast Cancer Res Treat ， 2021 ， 188 （ 3 ）： 631 - 640 .

XIE L Q ， ZHANG E H ， XU Y P ， et al . Demonstrating analytical similarity of trastuzumab biosimilar HLX02 to herceptin ® with a panel of sensitive and orthogonal methods including a novel FcγRⅢa affinity chromatography technology [J ] . BioDrugs ， 2020 ， 34 （ 3 ）： 363 - 379 .

XU B H ， ZHANG Q Y ， SUN T ， et al . Efficacy，safety，and immunogenicity of HLX02 compared with reference trastuzumab in patients with recurrent or metastatic HER2-positive breast cancer：a randomized phase Ⅲ equivalence trial [J ] . BioDrugs ， 2021 ， 35 （ 3 ）： 337 - 350 .

WU Q J ， ZHANG P F ， WANG X Y ， et al . Cost-effectiveness of capecitabine + irinotecan versus leucovorin + fluorouracil + irinotecan in the second-line treatment of metastatic colorectal cancer in China [J ] . Clin Ther ， 2020 ， 42 （ 11 ）： 2148 - 2158.e2 .

DENG W S ， HU J ， LI M T ， et al . Trastuzumab biosimilar HLX02 versus reference trastuzumab in patients with recurrent or metastatic HER2-positive breast cancer：a model-based economic evaluation for China [J ] . Expert Rev Pharmacoecon Outcomes Res ， 2022 ， 22 （ 7 ）： 1117 - 1126 .

LEVY-PIEDBOIS C ， DURAND-ZALESKI I ， JUHEL H ， et al . Cost-effectiveness of second-line treatment with irinotecan or infusional 5-fluorouracil in metastatic colorectal cancer [J ] . Ann Oncol ， 2000 ， 11 （ 2 ）： 157 - 161 .

国家卫生健康委员会 . 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 .

National Health Commission . Report on nutrition and chronic disease status of Chinese residents：2020 [J ] . J Nutr ， 2020 ， 42 （ 6 ）： 521 .

PHUA L C ， LEE S C ， NG K ， et al . Cost-effectiveness analysis of atezolizumab in advanced triple-negative breast cancer [J ] . BMC Health Serv Res ， 2020 ， 20 （ 1 ）： 581 .

国家统计局 . 中华人民共和国2023年国民经济和社会发展统计公报 [EB/OL ] . [ 2024-03-07 ] . https：//www.stats.gov.cn/sj/zxfb/202402/t20240228_1947915.html https://www.stats.gov.cn/sj/zxfb/202402/t20240228_1947915.html .

National Bureau of Statistics . Statistical bulletin on national economic and social development of the People’s Republic of China in 2023 [EB/OL ] . [ 2024-03-07 ] . https：//www.stats.gov.cn/sj/zxfb/202402/t20240228_1947915.html https://www.stats.gov.cn/sj/zxfb/202402/t20240228_1947915.html .

PENG Z ， HOU X D ， HUANG Y M ， et al . Cost-effectiveness analysis of fruquintinib for metastatic colorectal cancer third-line treatment in China [J ] . BMC Cancer ， 2020 ， 20 （ 1 ）： 990 .

KAY J . Are there benefits and risks to biosimilars from a patient perspective? [J ] . Rheum Dis Clin North Am ， 2019 ， 45 （ 3 ）： 465 - 476 .

LIU T ， LIU D ， JIN Y ， et al . Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer：a systematic review and network meta-analysis [J ] . Immunopharmacol Immunotoxicol ， 2022 ， 44 （ 6 ）： 809 - 815 .

孟蕊，芮明军，王欣恬，等 . 不同决策分析模型在抗肿瘤药物经济学评价中的应用：以加拿大CADTH为例 [J ] . 中国药房， 2021 ， 32 （ 14 ）： 1752 - 1757 .

MENG R ， RUI M J ， WANG X T ， et al . Application of different decision analysis models in the economic evaluation of antitumor drugs：taking CADTH in Canada as an example [J ] . Chin Pharm ， 2021 ， 32 （ 14 ）： 1752 - 1757 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Cost-utility analysis of tislelizumab monotherapy for second-line treatment of advanced or metastatic esophageal squamous cell carcinoma

Pharmacoeconomic evaluation of durvalumab combined with chemotherapy as first-line therapy for advanced biliary tract cancer

Pharmacoeconomic evaluation of penpulimab in first-line treatment of advanced squamous non-small-cell lung cancer

Pharmacoeconomic evaluation of iruplinalkib therapy for advanced ALK-positive non-small cell lung cancer

Cost-utility analysis of sugemalimab combined with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma with high PD-L1 expression

Related Author

GAO Chuan

DONG Juanni

LONG Lihui

RONG Biaoxue

WEN Enhui

FENG Rui

SUN Xiaoli

SHAN Bin

Related Institution

Dept. of Oncology， the First Affiliated Hospital of Xi’an Medical University

Clinical Pharmaceutics Room， the First Affiliated Hospital of Xi’an Medical University

School of Health Emergency Management， Tianjin University

School of Pharmacy， Hebei Medical University

Dept. of Pharmacy， the Fourth Hospital of Hebei Medical University

Address：8th Floor, Sihuan Building, No. 129 Daping Main Street, Yuzhong District, Chongqing, China Postal code：400042
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰