中国早期乳腺癌患者化疗后接受聚乙二醇化重组人粒细胞刺激因子初级预防的成本效果分析  

Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China

作　　者：夏雯 王树森[1] 胡皓 赵绯丽 徐菲 洪若曦 蒋逵葵 袁中玉[1] 史艳侠[1] 赵琨 黄嘉佳 薛聪 毕锡文 陆倩仪 安欣[1] 张靖敏 Xia Wen;Wang Shusen;Hu Hao;Zhao Feili;Xu Fei;Hong Ruoxi;Jiang Kuikui;Yuan Zhongyu;Shi Yanxia;Zhao Kun;Huang Jiajia;Xue Cong;Bi Xiwen;Lu Qianyi;An Xin;Zhang Jingmin(Department of Oncology,Sun Yat-sen University Cancer Center,Guangzhou 510060,China;China National Health Development Research Center,Beijing 100044,China;School of Biomedical Sciences and Pharmacy,Faculty of Health and Medicine,The University of Newcastle,Callaghan 2308,Australia)

机构地区：[1]中山大学附属肿瘤医院肿瘤内科,广州510060 [2]国家卫生健康委员会卫生发展研究中心,北京100044 [3]澳大利亚新南威尔士州纽卡斯尔大学生物医学与药学学院卫生与医学系,卡拉汉2308

出　　处：《中华肿瘤杂志》2020年第10期861-867,共7页Chinese Journal of Oncology

摘　　要：目的评估中国早期乳腺癌女性患者,接受聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)初级预防与接受重组人粒细胞刺激因子(rhG-CSF)初级预防或无预防的成本-效果。方法构建2种状态Markov模型,假定队列患者是年龄为45岁的Ⅱ期乳腺癌患者。第1种状态模拟4个周期多西他赛联合环磷酰胺[发热性中性粒细胞减少(FN)风险>20%]化疗的成本和结果,其假设基于文献综述,包括FN发生率[基线(确定敏感性分析范围),0.29(0.24~0.35)]和相关事件[FN病死率,3.4(2.7~4.1)]。第2种状态模拟长期生存,并与相对剂量强度(RDI)[RDI<85%和≥85%的死亡风险比为1.45(1.00~2.32)]进行关联。临床效果、治疗成本和经济学效用值是基于同行评审的出版物和专家意见。结果与rhG-CSF初级预防和无预防治疗方案比较,PEG-rhG-CSF初级预防成本分别增加了5208.19元和5222.73元,质量调整生命年(QALYs)分别提高了0.066年和0.297年。因此,增量成本-效果比分别为79146.3元/QALY和17558.77元/QALY,均低于世界卫生组织建议的3倍人均国内生产总值(18000元)的意愿支付阈值。敏感性分析显示,PEG-rhG-CSF初级预防的临床效果越好,越具有成本-效果优势。RDI<85%对比≥85%的死亡风险比越低,PEG-rhG-CSF初级预防越具有成本-效果优势。结论尽管PEG-rhG-CSF初级预防的成本较高,但考虑到其额外的收益,中国FN风险>20%的早期乳腺癌患者采用PEG-rhG-CSF初级预防与rhG-CSF初级预防或无预防相比,PEG-rhG-CSF很可能是一种具有成本-效果的替代方法。Objective To evaluate the cost effectiveness of primary prophylaxis(PP)with pegylated recombinant human granulocyte colony stimulating factor(PEG-rhG-CSF),PP with recombinant human granulocyte colony stimulating factor(rhG-CSF)and no prophylaxis in women with early-stage breast cancer in China.Methods Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stageⅡbreast cancer.The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide[TC×4,febrile neutropenia(FN)risk>20%]chemotherapy,which assumptions based on literature reviews,including FN rates[base-case(deterministic sensitivity analysis range),0.29(0.24-0.35)]and related events[FN case-fatality,3.4(2.7-4.1)].Second phase modelled the long term survival which was link with the relative dose intensity(RDI)[mortality hazard ratio(HR)of RDI<85%vs≥85%,1.45(1.00-2.32)].Clinical effectiveness,therapeutic costs,and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences.Results Compared to rhG-CSF PP and no prophylaxis,the cost of PEG-rhG-CSF PP increased to 5208.19 RMB and 5222.73 RMB,respectively.The quality-adjusted life-years(QALYs)enhanced to 0.066 and 0.297,respectively.Accordingly,the incremental cost effectiveness ratios(ICERs)are 79146.3 RMB and 17558.77 RMB per QALY,which were both below the willingness to pay(WTP)threshold of three times GDP per capita(18,000 RMB)recommended by the WHO.Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is,the more cost-effective primary prophylaxis with PEG-rhG-CSF will be.And the lower the mortality HR of RDI<85%vs≥85%is,the more cost-effective primary prophylaxis with PEG-rhG-CSF will be.Conclusion Although the cost of PP PEG-rhG-CSF is higher,considering the additional benefits,the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with

关 键 词：乳腺肿瘤 聚乙二醇化重组人粒细胞刺激因子 初级预防 成本-效果 

分 类 号：R737.9[医药卫生—肿瘤]