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·药物经济学·


          瑞戈非尼治疗经索拉非尼治疗失败后的肝细胞癌的经济性                                                                  Δ


          洪望龙 ,郑淼淼 ,马国强 ,朱文涛 ,沈爱宗                  1, 2 # [1.安徽中医药大学药学院,合肥 230012;2.中国科学技术大
                           1
                                           1
                                   1
                 1*
          学附属第一医院(安徽省立医院)药剂科,合肥 230001]
          中图分类号  R956;R979.1      文献标志码  A      文章编号  1001-0408(2023)08-0968-06
          DOI  10.6039/j.issn.1001-0408.2023.08.14

          摘   要  目的  从我国卫生体系角度出发,评估瑞戈非尼治疗经索拉非尼治疗失败后的肝细胞癌的经济性。方法  基于一项Ⅲ期
          临床试验(RESORCE研究),分别构建分区生存模型(PSM)和Markov模型,循环周期设为4周,研究时限为患者终身,年贴现率为
          5%,药品成本数据来自药智网,其他成本数据来源于安徽省医保局数据和相关文献,效用数据来源于文献。以增量成本-效果比
         (ICER)为评价指标,意愿支付值为3倍的我国2022年人均国内生产总值(GDP),采用单因素敏感性分析和概率敏感性分析验证
          基础分析结果的稳健性。结果  瑞戈非尼组对比安慰剂组在PSM和Markov模型中的增量成本分别为112 116.95元、96 617.19元;
          增量效果分别为0.31、0.32 QALYs;ICER分别为360 751.01、301 114.45元/QALY,ICER均大于意愿支付值,瑞戈非尼不具有经济
          性。单因素敏感性分析结果显示,无进展生存期状态和疾病进展状态的效用值以及瑞戈非尼单价对结果的影响较大,但在各参数
          浮动范围内,ICER始终大于意愿支付值;在 3 倍的我国 2022 年人均 GDP 的意愿支付值下,瑞戈非尼具有经济性的概率为 0.8%
         (PSM)、11.4%(Markov 模型)。结论  在3倍的我国人均GDP下,瑞戈非尼对比安慰剂治疗经索拉非尼治疗失败后的肝细胞癌不
          具有经济性。
          关键词  瑞戈非尼;肝细胞癌;分区生存模型;Markov模型;药物经济学

          Cost-effectiveness of regorafenib for hepatocellular carcinoma after failure of sorafenib
          HONG Wanglong ,ZHENG Miaomiao ,MA Guoqiang ,ZHU Wentao ,SHEN Aizong [1. School of Pharmacy,
                                                          1
                                            1
                          1
                                                                                     1, 2
                                                                       1
          Anhui University of Chinese Medicine, Hefei 230012, China;2. Dept. of Pharmacy, the First Affiliated Hospital
          of University of Science and Technology of China(Anhui Provincial Hospital), Hefei 230001, China]
          ABSTRACT    OBJECTIVE  To  evaluate  the  cost-effectiveness  of  regorafenib  in  the  treatment  of  hepatocellular  carcinoma  after
          failure  of  sorafenib  from  the  perspective  of  Chinese  health  system.  METHODS  Based  on  a  phase  Ⅲ  trial(RESORCE),  the
          partition  survival  model (PSM)  and  Markov  model  were  constructed.  The  cycle  was  set  as  four  weeks,  the  duration  of  the  study
          lasted for lifetime, the annual discount rate was 5%. Drug cost data was obtained from yaozhi.com, other cost data were obtained
          from  Anhui  Provincial  Medical  Insurance  Bureau  and  related  literature,  and  utility  values  were  obtained  from  literature.  The
          incremental cost-effectiveness ratio (ICER) was used as the evaluation index, and the value of willingness to pay (WTP) was three
          times  of  China’s  gross  domestic  product (GDP)  per  capita  in  2022;  one-way  sensitivity  analysis  and  probabilistic  sensitivity
          analysis  were  used  to  verify  the  robustness  of  the  basic  analysis  results.  RESULTS  The  incremental  cost  of  regorafenib  group  versus
          placebo  group  in  PSM  and  Markov  model  was  112  116.95  yuan  and  96  617.19  yuan,  respectively.  The  incremental  effectiveness
          was 0.31 QALYs and 0.32 QALYs, respectively. The ICERs were 360 751.01 yuan/QALY and 301 114.45 yuan/QALY, which
          were  both  greater  than  the  value  of  WTP;  regorafenib  was  not  cost-effective.  Results  of  one-way  sensitivity  analysis  showed  that  the
          utility of progression-free survival and progressive disease, the unit cost of regorafenib had the greatest influence on the results, but
          ICER was always greater than the WTP within the floating range of each parameter. Under the WTP of 3 times China’s per capita
          GDP  in  2022,  the  probabilities  of  regorafenib  with  cost-effectiveness  were  0.8% (PSM)  and  11.4% (Markov).  CONCLUSIONS
          Under  the  WTP  of  3  times  the  per  capita  GDP  of  China,  regorafenib  is  not  cost-effective  in  the  treatment  of  hepatocellular
          carcinoma after failure of sorafenib treatment, compared with placebo.
          KEYWORDS     regorafenib; hepatocellular carcinoma; partition survival model; Markov model; pharmacoeconomics


              Δ 基金项目 安徽高效协同创新项目(No.GXXT-2021-068)                 原发性肝癌,是全球范围内常见的消化系统肿瘤。
              *第一作者 硕士研究生。研究方向:药物经济学。E-mail:                  根据国际癌症研究机构公布的数据,2020年全球肝癌的
          2293480254@qq.com
                                                              年新发病例数达到96.6万人,居于恶性肿瘤的第6位;病
              # 通信作者 主任药师,硕士生导师。研究方向:药物经济学、药事
          管理。E-mail:1649441800@qq.com                         死人数达 83.0 万,居于恶性肿瘤的第 3 位。肝癌在我国


          · 968 ·    China Pharmacy  2023 Vol. 34  No. 8                               中国药房  2023年第34卷第8期
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