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·药物经济学·


          德曲妥珠单抗对比恩美曲妥珠单抗二线治疗 HER2 阳性转移性
          乳腺癌的成本-效用分析
                                               Δ


                *
                                 #
          武亚楠 ,吴 方,侯艳红(中国药科大学国际医药商学院,南京 211198)
          中图分类号  R956;R979.1      文献标志码  A      文章编号  1001-0408(2024)02-0204-06
          DOI  10.6039/j.issn.1001-0408.2024.02.14

          摘   要  目的  评估德曲妥珠单抗(T-DXd)对比恩美曲妥珠单抗(T-DM1)二线治疗HER2阳性转移性乳腺癌的经济性,为临床用
          药方案的选择及医疗卫生决策提供依据。方法  基于DESTINY-Breast03试验构建分区生存模型,以3周为循环周期,模拟至患者
          终身。以质量调整生命年(QALY)作为产出指标并计算增量成本-效果比(ICER),再利用敏感性分析验证基础分析结果的稳健
          性,以此来比较 T-DXd 与 T-DM1 二线治疗 HER2 阳性转移性乳腺癌的经济性。结果  在以 3 倍我国 2022 年人均国内生产总值
         (GDP)为意愿支付阈值(257 094元/QALY)的前提下,使用T-DXd方案的患者在获得增量效用(0.69 QALYs)的同时也需要支付更
          多成本,ICER 值为 1 850 478.40 元/QALY。单因素敏感性分析结果显示,对 ICER 影响较大的因素有无进展生存期状态效用值、
          T-DXd价格、成本贴现率等,但这些参数在合理范围内波动均不能使基础分析结果发生翻转。概率敏感性分析结果显示,当WTP
          的阈值上升为1 500 400元/QALY时,T-DXd方案具有经济性的概率为50%。情境分析结果也验证了基础分析结果的稳健性。结论
          在以3倍我国人均GDP为意愿支付阈值的前提下,与T-DM1方案相比,T-DXd二线治疗HER2阳性转移性乳腺癌不具有经济性。
          关键词  德曲妥珠单抗;恩美曲妥珠单抗;HER2阳性转移性乳腺癌;分区生存模型;成本-效用分析

          Cost-utility analysis of trastuzumab deruxtecan versus trastuzumab emtansine in the second-line treatment
          for HER22-positive metastatic breast cancer
          WU Yanan,WU Fang,HOU Yanhong(School  of  International  Pharmaceutical  Business,China  Pharmaceutical
          University,Nanjing 211198,China)

          ABSTRACT    OBJECTIVE  To  evaluate  the  cost-effectiveness  of  trastuzumab  deruxtecan(T-DXd)  versus  trastuzumab  emtansine
         (T-DM1) in the second-line treatment of HER2-positive metastatic breast cancer, and to provide a basis for the selection of clinical
          medication  regimen  and  medical  and  health  decisions.  METHODS  Based  on  the  clinical  trial  DESTINY-Breast03,  a  partitioned
          survival model was constructed, with a cycle of 3 weeks as the simulation of patients’ lifetime. The incremental cost-effectiveness
          ratio (ICER) was calculated by using quality-adjusted life years (QALY) as output indicators, and sensitivity analysis was used to
          verify  the  robustness  of  the  basic  analysis  results;  the  cost-effectiveness  of  the  second-line  treatment  for  HER2-positive  metastatic
          breast cancer was compared between T-DXd and T-DM1. RESULTS Under the premise of taking 3 times China’s per capita gross
          domestic product (GDP) in 2022 as the willingness-to-pay threshold (257 094 yuan/QALY), the T-DXd group also needed to pay
          more cost compared with T-DM1 group while obtaining incremental utility (0.69 QALYs), and the ICER value was 1 850 478.40
          yuan/QALY. The results of univariate sensitivity analysis showed that progression-free survival state utility value, T-DXd price, cost
          discount  rate  were  factors  that  had  a  great  influence  on  ICER  value,  but  these  parameters  could  not  flip  the  basic  analysis  results
          within  a  reasonable  range.  In  the  probability  sensitivity  analysis,  when  the  threshold  of  willingness-to-pay  rose  to  1 500 400
          yuan/QALY, the probability of economic activity was 50% in the T-DXd regimen. The results of the scenario analysis also verified
          the robustness of the original research results. CONCLUSIONS Under the premise of 3 times China’s per capita GDP as the WTP
          threshold,  compared  with  T-DM1,  T-DXd  is  not  cost-effective  in  the  second-line  treatment  of  HER2-positive  metastatic  breast
          cancer.
          KEYWORDS     trastuzumab  deruxtecan;  trastuzumab  emtansine;  HER2-positive  metastatic  breast  cancer;  partitioned  survival
          model; cost-utility analysis

              Δ 基金项目 国家社会科学基金项目(No.22BGL252)                      乳腺癌是女性最常见的恶性肿瘤。根据WHO国际
             *第一作者 硕士研究生。研究方向:医药产业经济与政策。
                                                              癌 症 机 构(International  Agency  Research  on  Cancer,
          E-mail:15253894826@163.com
              # 通信作者 副教授,硕士生导师,博士。研究方向:医药产业经济                 IARC)发布的2020年全球癌症负担数据显示,世界范围
          与政策。E-mail:1020092084@cpu.edu.cn                    内乳腺癌的发病例数高居第一,在因癌症死亡的原因中


          · 204 ·    China Pharmacy  2024 Vol. 35  No. 2                               中国药房  2024年第35卷第2期
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