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目的:从医疗保障部门角度对曲妥珠单抗辅助治疗早期HER2阳性乳腺癌进行药物经济学评价,为推进乳腺癌规范诊疗和医保政策制定提供依据和参考。方法:基于HERA临床试验,运用Markov模型模拟乳腺癌的发展,比较早期乳腺癌曲妥珠单抗1年辅助治疗组与观察组的成本效用,并进行经济学分析。结果:若采用曲妥珠单抗辅助治疗,患者的期望生存年、质量调整生命年将分别延长4.30年、2.86年,延长1年所需增加的医疗费用分别为96 334元、144 936元。结论:在湖北省使用曲妥珠单抗辅助治疗早期HER2阳性乳腺癌具有较好的成本效用,湖北省或经济发展水平相当及较高的省市医保部门可以考虑将曲妥珠单抗纳入到医保目录。
OBJECTIVE: To evaluate the pharmacoeconomic evaluation of trastuzumab adjuvant therapy for early HER2-positive breast cancer from the perspective of the medical security department, and to provide the basis and references for promoting the standard diagnosis and treatment of breast cancer and the policy of health insurance. Methods: Based on the HERA clinical trial, the Markov model was used to simulate the development of breast cancer. The cost-effectiveness of 1-year adjuvant therapy and observation group with trastuzumab in early breast cancer was compared and the economic analysis was conducted. Results: In the case of trastuzumab adjuvant therapy, the expected life-years and quality-adjusted life years of patients were extended by 4.30 years and 2.86 years respectively. The additional medical expenses for one year extension were 96,334 yuan and 144,936 yuan respectively. Conclusions: The use of trastuzumab adjuvant to treat early-stage HER2-positive breast cancer in Hubei Province is cost-effective. In Hubei Province, provincial and municipal health insurance departments with relatively high economic development levels may consider adding trastuzumab to Medicare directory.