Page 91 - 《中国药房》2026年5期
P. 91

埃万妥单抗联合兰泽替尼一线治疗EGFR突变晚期NSCLC的成

          本-效用分析
                             Δ

                                                            1 #
                                                    1
                                            1
                           3
          刘 冉    1， 2＊ ，高胜男 ，张羽曦 ，张冉冉 ，李从欣 ，刘国强 （1.河北医科大学第三医院药学部，石家庄 050051；
                                    1
          2.河北医科大学研究生学院，石家庄 050017；3.河北省药物与卫生技术综合评估学会，石家庄 050051）
          中图分类号  R956；R979.1      文献标志码  A      文章编号  1001-0408（2026）05-0633-06
          DOI  10.6039/j.issn.1001-0408.2026.05.14

          摘  要  目的  从我国卫生体系角度出发，评价埃万妥单抗联合兰泽替尼（以下简称“AL”）方案一线治疗EGFR突变晚期非小细胞
          肺癌（NSCLC）的经济性。方法  根据MARIPOSA研究最新数据构建分区生存模型，模拟时限设置为10年，循环周期为28 d，以质
          量调整生命年（QALY）为主要输出指标，以3倍2024年我国人均国内生产总值为意愿支付（WTP）阈值（287 247元/QALY），采用成
          本-效用分析法，计算AL相对于奥希替尼单药方案一线治疗EGFR突变晚期NSCLC的增量成本-效果比（ICER）；采用单因素敏感
          性分析和概率敏感性分析评估模型的稳健性；采用情境分析评估不同健康状态效用值对结果的影响，并确定AL方案具有经济性时埃
          万妥单抗和兰泽替尼的降价幅度。结果  相对于奥希替尼单药方案，AL方案一线治疗EGFR突变晚期NSCLC的ICER为2 062 096.15
          元/QALY，远高于本研究设定的WTP阈值。单因素敏感性分析结果显示，无进展生存状态效用值和埃万妥单抗价格是影响ICER
          的主要因素。概率敏感性分析结果显示，当WTP阈值为2 050 000元/QALY时，AL方案才开始具有经济性。情境分析结果显示，
          改变效用值，AL方案依然不具有经济性；当埃万妥单抗（350 mg）价格分别下降80%、85%、90%时，兰泽替尼（80 mg）需分别降价
          95.97%、40.63%、5.29%，才能让AL方案的ICER稳定落在上述WTP阈值内。结论  在本研究设定的WTP阈值下，相对于奥希替尼
          单药方案，AL方案一线治疗EGFR突变晚期NSCLC不具有经济性；联合药物需要同时大幅降价，才能减轻患者的用药负担。
          关键词  埃万妥单抗；兰泽替尼；奥希替尼；非小细胞肺癌；EGFR突变；药物经济学；成本-效用分析；分区生存模型

          Cost-utility analysis of amivantamab combined with lazertinib in the first-line treatment of EGFR-mutated
          advanced NSCLC
          LIU Ran ，GAO Shengnan ，ZHANG Yuxi ，ZHANG Ranran ，LI  Congxin ，LIU Guoqiang （1.  Dept.  of
                                                                                1
                                                                   1
                                                  1
                  1，2
                                   3
                                                                                                1
          Pharmacy， Hebei Medical University Third Hospital， Shijiazhuang 050051， China；2. Graduate School of Hebei
          Medical  University，  Shijiazhuang  050017，  China；3.  Hebei  Society  for  Integrated  Drug  and  Health  Technology
          Assessment， Shijiazhuang 050051， China）
          ABSTRACT   OBJECTIVE To evaluate the cost-effectiveness of amivantamab combined with lazertinib （hereinafter referred to as
         “AL”）  regimen  as  first-line  treatment  for  EGFR-mutated  advanced  non-small  cell  lung  cancer （NSCLC）  from  the  perspective  of
          China’s  healthcare  system.  METHODS  A  partitioned  survival  model  was  established  based  on  updated  data  from  the  MARIPOSA
          study， with a 10-year time horizon and 28-day cycles. The primary outcome index was quality adjusted life year （QALY）， and the
          willingness-to-pay （WTP）  threshold  was  set  at  three  times  China’s  per  capita  GDP  in  2024 （287  247  yuan/QALY）.  Cost-utility
          analysis  was  used  to  calculate  the  incremental  cost-effectiveness  ratio （ICER）  of  AL  regimen  versus  osimertinib  monotherapy
          regimen as first-line treatment for EGFR-mutated advanced NSCLC. One-way and probabilistic sensitivity analyses were performed
          to  test  model  robustness.  Scenario  analyses  were  conducted  to  explore  the  impact  of  utility  values  for  different  health  states  on  the
          outcomes  and  determine  the  required  price  reductions  of  amivantamab  and  lazertinib  to  achieve  cost-effectiveness.  RESULTS
          Compared  with  the  osimertinib  monotherapy  regimen，  the  ICER  for  the  AL  regimen  as  first-line  treatment  for  advanced  EGFR-
          mutated  NSCLC  was  2  062  096.15  yuan/QALY，  significantly  exceeding  the  WTP  threshold  established  in  this  study.  One-way
          sensitivity  analysis  revealed  that  the  utility  value  of  progression-free  survival  state  and  the  price  of  amivantamab  were  the  primary
          factors  influencing  the  ICER.  Probabilistic  sensitivity  analysis  revealed  that  the  AL  regimen  only  became  cost-effective  when  the
          WTP  threshold  was  set  at  2  050  000  yuan/QALY.  Scenario  analysis  indicated  that  altering  the  utility  value  still  rendered  the  AL
          regimen  non-cost-effective.  When  amivantamab （350  mg）  prices  decreased  by  80%，  85%，  and  90%  respectively，  lazertinib （80
          mg）  prices  would  need  to  decrease  by  95.97%，  40.63%，  5.29%，  respectively.  This  would  enable  the  AL  regimen’s  ICER  to
          consistently  fall  within  the  WTP  threshold  established  in  this  study.  CONCLUSIONS  At  the  WTP  threshold  established  in  this
                                                             study，  the AL  regimen  does  not  demonstrate  cost-effectiveness
             Δ 基金项目 河北省自然科学基金项目（No.H2024206062）
             ＊第一作者 硕士研究生。研究方向：药物经济学。E-mail：                  for  first-line  treatment  of  advanced  EGFR-mutated  NSCLC
          2449898635@qq.com                                  compared  to  the  osimertinib  monotherapy  regimen.  Significant
             # 通信作者 主任药师，硕士生导师，硕士。研究方向：药物经济                  price  reductions  for  both  drugs  would  be  required  to  alleviate
          学、卫生技术评估、合理用药。E-mail：36700774@hebmu.edu.cn         the financial burden on patients.


          中国药房  2026年第37卷第5期                                                 China Pharmacy  2026 Vol. 37  No. 5    · 633 ·
   86   87   88   89   90   91   92   93   94   95   96