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Title: [Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China].
Author: Xia W, Wang SS, Hu H, Zhao FL, Xu F, Hong RX, Jiang KK, Yuan ZY, Shi YX, Zhao K, Huang JJ, Xue C, Bi XW, Lu QY, An X, Zhang JM.
Journal: Zhonghua Zhong Liu Za Zhi; 2020 Oct 23; 42(10):861-867. PubMed ID: 33113628.
Abstract:
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 stage Ⅱ breast 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 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 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 early stage breast cancer whose FN risks are more than 20% in China. 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5 208.19元和5 222.73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79 146.3元/QALY和17 558.77元/QALY，均低于世界卫生组织建议的3倍人均国内生产总值(18 000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。.

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