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·药物经济学·


          舒格利单抗巩固治疗Ⅲ期非小细胞肺癌的药物经济学评价
                                                                                                    Δ

                            3
          苏 杭    1, 2* ,王 琳 ,韩 晟 (1.北京大学药学院,北京 100191;2.北京大学医药管理国际研究中心,北京
                                    1, 2 #
          100191;3.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(2023)13-1606-05
          DOI  10.6039/j.issn.1001-0408.2023.13.12

          摘 要  目的  从我国卫生体系角度出发,评价舒格利单抗巩固治疗同步或序贯放化疗后疾病未进展的Ⅲ期非小细胞肺癌
         (NSCLC)患者的经济性。方法  基于 GEMSTONE-301 研究,建立三状态的分区生存模型模拟疾病发展进程,模型周期定义为 3
          周,时间范围为终生;主要模型输出指标为总成本、质量调整生命年(QALY)和增量成本-效果比(ICER);采用5%的贴现率对成本
          和健康产出进行贴现。以1~3倍我国2022年人均国内生产总值(GDP)作为意愿支付阈值,采用成本-效用分析法进行分析,并采
          用情境分析和敏感性分析来验证模型的稳健性。结果  与安慰剂相比,舒格利单抗巩固治疗方案的ICER为59 872.57元/QALY,
          小于以1倍我国2022年人均GDP(85 698元)作为的意愿支付阈值;情境分析结果进一步确定了模型的稳健性。单因素敏感性分
          析结果表明,药品(帕博利珠单抗、舒格利单抗、多西他赛)成本、疾病进展状态效用值等对ICER的影响较大。概率敏感性分析结
          果显示,在以 1 倍我国 2022 年人均 GDP 作为意愿支付阈值的前提下,舒格利单抗巩固治疗方案具有经济性的概率为 67.2%;在
          以 20 000元[小于3倍我国2022年人均GDP(257 094元)]作为意愿支付阈值时,舒格利单抗巩固治疗方案具有经济性的概率超过
          98%。结论  舒格利单抗巩固治疗同步或序贯放化疗后疾病未进展的Ⅲ期NSCLC具有经济性。
          关键词  舒格利单抗;Ⅲ期非小细胞肺癌;成本-效用分析;分区生存模型;药物经济学

          Pharmacoeconomic evaluation of sugemalimab consolidation therapy for stage Ⅲ non-small cell lung cancer
          SU Hang ,WANG Lin ,HAN Sheng (1.  School  of  Pharmaceutical  Sciences,  Peking  University,Beijing
                   1,2
                                3
                                              1,2
          100191,China;2.  International  Research  Center  for  Medicinal  Administration,  Peking  University,  Beijing
          100191,  China;3.  School  of  International  Pharmaceutical  Business,China  Pharmaceutical  University,Nanjing
          211198,China)

          ABSTRACT    OBJECTIVE To evaluate the cost-effectiveness of sugemalimab in patients with stage Ⅲ non-small cell lung cancer
         (NSCLC)  whose  disease  had  not  progressed  after  concurrent  or  sequential  chemoradiotherapy  from  the  perspective  of  the  Chinese
          healthcare  system.  METHODS  Based  on  the  GEMSTONE-301  clinical  trial,a  three-health  state  partitioned  survival  model
         (PartSA)  was  developed  to  simulate  the  progression  of  disease,with  model  cycle  of  3  weeks  and  a  lifetime  time  range;  the  main
          output indicators of the model were total cost,quality-adjusted life year (QALY),and incremental cost-effectiveness ratio (ICER);
          the  cost  and  health  output  were  discounted  using  5%  discount  rate.  Using  1-3  times  China’s  per  capita  gross  domestic  product
         (GDP)  in  2022  as  the  willingness-to-pay (WTP)  threshold,the  cost-utility  analysis  method  was  used  for  analysis,and  sensitivity
          analysis  and  scenario  analysis  were  conducted  to  assess  model  robustness.  RESULTS  Compared  with  placebo,ICER  for
          sugemalimab  consolidation  therapy  was  59  872.57  yuan/QALY,which  was  less  than  one  time  China’s  per  capita  GDP  in  2022
         (85  698  yuan)  as  the  WTP  threshold.  The  scenario  analysis  results  further  confirmed  the  robustness  of  the  model.  The  results  of
          single  factor  sensitivity  analysis  indicated  that  the  cost  of  drugs (pembrolizumab,sugemalimab,docetaxel)  and  the  utility  value  of
          disease  progression  status  had  a  significant  impact  on  ICER;  the  results  of  the  probabilistic  sensitivity  analysis  showed  that
          sugemalimab  had  67.2%  probability  of  being  cost-effective  at  one  time  China’s  GDP  per  capita  in  2022  as  the  WTP  threshold;
          when 20 000 yuan (less than 3 times GDP per capita in China of 257 094 yuan) was used as the WTP threshold,the probability of
          sugemalimab  consolidation  therapy  being  cost-effective  was  greater  than  98%.  CONCLUSIONS  The  consolidation  therapy  with
          sugemalimab  is  cost-effective  for  stage  Ⅲ  NSCLC  whose  disease  had  not  progressed  after  concurrent  or  sequential
          chemoradiotherapy.
          KEYWORDS     sugemalimab; stage Ⅲ non-small cell lung cancer; cost-utility analysis; partitioned survival model; pharmacoeconomics


              Δ 基金项目 国家自然科学基金资助项目(No.82273899)                    肺癌是我国发病率最高的癌症,约85%的肺癌患者
             *第一作者 硕士。研究方向:药物经济学。E-mail:sh9975206@
                                                              被 诊 断 为 非 小 细 胞 肺 癌(non-small  cell  lung  cancer,
          163.com
              # 通信作者 研究员,硕士生导师,博士。研究方向:卫生政策、药                 NSCLC),其中 1/3 的患者在诊断时被报告为Ⅲ期,即为
                                                                        [1]
          物经济学、大数据分析。E-mail:hansheng@bjmu.edu.cn              中晚期肺癌 。对于无法切除的Ⅲ期NSCLC,同步或序

          · 1606 ·    China Pharmacy  2023 Vol. 34  No. 13                            中国药房  2023年第34卷第13期
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