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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
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| 篇名： | 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 |
| TITLE： | Pharmacoeconomic evaluation of trastuzumab biosimilars versus original drug in the treatment of recurrent/metastatic HER-2 positive breast cancer |
| 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111516.72、111122.30元，效用分别为1.52、1.36QALYs，增量成本-效果比（ICER）为2465.12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（268200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14902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（268200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. |
| 期刊： | 2024年第35卷第09期 |
| 作者： | 邢玥；刘通；滕雪；董梅 |
| AUTHORS： | XING Yue，LIU Tong，TENG Xue，DONG Mei |
| 关键字： | 曲妥珠单抗；人表皮生长因子受体2；乳腺癌；分区生存模型；药物经济学；成本-效用分析；原研药；生物仿制药 |
| KEYWORDS： | trastuzumab； human epidermal growth factor receptor-2； breast cancer； partitional survival model； |
| 阅读数： | 31 次 |
| 本月下载数： | 2 次 |
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