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·药物经济学·


          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
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          何银梅 ,李 晓 ,刘晓丽 ,李龙舟 ,高 彦 ,余建国 ,栾家杰 ,吴义来 (1.皖南医学院第二附属医院药剂
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          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)
          中图分类号  R956      文献标志码  A      文章编号  1001-0408(2024)20-2493-06
          DOI  10.6039/j.issn.1001-0408.2024.20.09
          摘  要  目的  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  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  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  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。
          关键词  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  analysis  of  sacituzumab  govitecan  versus  single-agent  chemotherapy  in  the  treatment  of  HR+/
          HER2- advanced metastatic breast cancer
          HE Yinmei ,LI Xiao ,LIU Xiaoli ,LI Longzhou ,GAO Yan ,YU Jianguo ,LUAN Jiajie ,WU Yilai(1. Dept. of
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          Pharmacy, the Second Affiliated Hospital of Wannan Medical College, Anhui Wuhu 241000, China;2. Dept. of
          Clinical Pharmacy, Yijishan Hospital of Wannan Medical College, Anhui Wuhu 241000, China)
          ABSTRACT   OBJECTIVE  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  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  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  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.
             Δ 基金项目 中华医学会临床药学专项科研基金                          KEYWORDS     sacituzumab  govitecan;  cost-utility  analysis;
             *第一作者 药师,硕士。研究方向:临床药学和药事管理。                     HR+/HER2-  advanced  metastatic  breast  cancer;  partitioned
          E-mail:550474918@qq.com
                                                             survival model; pharmacoeconomics
             # 通信作者 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


          中国药房  2024年第35卷第20期                                              China Pharmacy  2024 Vol. 35  No. 20    · 2493 ·
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