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兔抗胸腺细胞球蛋白与抗胸腺细胞球蛋白-弗雷森纽斯在中国心脏死亡供体肾移植患者诱导治疗中的成本效果分析。

A Cost-effectiveness Analysis of Rabbit Antithymocyte Globulin Versus Antithymocyte Globulin-fresenius as Induction Therapy for Patients With Kidney Transplantation From Donation After Cardiac Death in China.

机构信息

Department of Health Policy and Management, University of North Carolina Gillings School of Public Health; Chapel Hill, North Carolina.

Organ Transplant Center, the First Affiliated Hospital of Sun Yat-sen University; Guangzhou, China.

出版信息

Clin Ther. 2018 Oct;40(10):1741-1751. doi: 10.1016/j.clinthera.2018.08.017. Epub 2018 Sep 20.

Abstract

PURPOSE

Induction immunosuppression therapy is used to support optimal outcomes in kidney transplantation. This study was to assess the cost-effectiveness of rabbit antithymocyte globulin (r-ATG) versus ATG-Fresenius (ATG-F) in kidney transplantation in the Chinese setting from the perspective of the health care payer.

METHODS

A 2-part survival model was developed, consisting of a short-term part and a long-term part. The short-term part analyzed the first year, using the decision tree, and consisted of the functioning transplant, acute rejection (AR), delayed graft function (DGF), dialysis, and death health states. The long-term part analyzed 2 to 5 years, using Markov model, and consisted of the functioning transplant, chronic dysfunction, recurring primary disease, dialysis, and death health states, with capture of the association between DGF and graft loss. Costs, including drug acquisition and other direct medical costs, were derived from China IQVIA database (formerly known as IMS) hospitaldatabase, chart review, and physician interviews. Clinical outcomes and utility were retrieved from published literature. The model calculated quality-adjusted life-years (QALYs) and total costs per patient. Costs and QALYs were discounted at an annual rate of 3.5%. Univariate sensitivity analysis and probability sensitivity analysis (PSA) were conducted to assess the impact of uncertainty of the variables on the results.

FINDINGS

Patients who received r-ATG had more clinical effectiveness than patients who received ATG-F mainly because of less AR, DGF, and dialysis. The incremental QALY was 0.01 over a 1-year time horizon and 0.0496 over a 5-year time horizon. R-ATG and ATG-F drug costs were ¥10,783 and ¥8409, respectively. However, the total treatment costs of the r-ATG arm were lower than the ATG-F arm because of lower costs related to DGF, AR, dialysis, and adverse events. In total, r-ATG saved ¥5423 over the 1-year and ¥7042 over the 5-year time horizon. R-ATG was dominant with lower total direct medical costs and higher QALYs compared with ATG-F. Both univariate sensitivity analysis and PSA found the robustness of the model results. PSA results indicated that r-ATG was cost-effective compared with ATG-F in 86.81% of the simulations, considering <3 times the gross domestic product per capita as the threshold.

IMPLICATIONS

From the perspective of the health care payer, r-ATG should be considered as the preferred treatment agent for induction therapy for Chinese patients undergoing kidney transplantation because of its lower overall medical costs and greater QALYs gained compared with ATG-F. The study was limited by lack of long-term efficacy data among the Chinese population and lack of comprehensive real-world higher quality costs data.

摘要

目的

诱导免疫抑制疗法用于支持肾移植的最佳结果。本研究旨在从医疗保健支付者的角度评估兔抗胸腺细胞球蛋白(r-ATG)与抗胸腺细胞球蛋白-弗雷森纽斯(ATG-F)在肾移植中的成本效益。

方法

建立了一个两部分生存模型,包括短期部分和长期部分。短期部分使用决策树分析第一年,包括功能移植、急性排斥反应(AR)、延迟移植物功能(DGF)、透析和死亡健康状态。长期部分使用 Markov 模型分析 2 至 5 年,包括功能移植、慢性功能障碍、复发性原发性疾病、透析和死亡健康状态,同时捕捉 DGF 与移植物丢失之间的关联。成本包括药物获得和其他直接医疗费用,来自中国 IQVIA 数据库(前身为 IMS)医院数据库、图表审查和医生访谈。临床结果和效用取自已发表的文献。该模型计算每位患者的质量调整生命年(QALY)和总成本。成本和 QALY 按每年 3.5%的贴现率贴现。进行了单变量敏感性分析和概率敏感性分析(PSA),以评估变量不确定性对结果的影响。

结果

接受 r-ATG 的患者比接受 ATG-F 的患者具有更好的临床效果,主要是因为 AR、DGF 和透析较少。在 1 年时间内,增量 QALY 为 0.01,在 5 年内为 0.0496。r-ATG 和 ATG-F 的药物成本分别为 ¥10783 和 ¥8409。然而,r-ATG 组的总治疗费用低于 ATG-F 组,因为与 DGF、AR、透析和不良事件相关的成本较低。总的来说,r-ATG 在 1 年内节省了 ¥5423,在 5 年内节省了 ¥7042。与 ATG-F 相比,r-ATG 具有更低的总直接医疗成本和更高的 QALYs,因此具有优势。单变量敏感性分析和 PSA 都发现了模型结果的稳健性。PSA 结果表明,考虑到中国人均国内生产总值(GDP)的 3 倍以下作为阈值,r-ATG 与 ATG-F 相比,在 86.81%的模拟中具有成本效益。

结论

从医疗保健支付者的角度来看,r-ATG 应该被视为接受肾移植的中国患者诱导治疗的首选治疗药物,因为与 ATG-F 相比,r-ATG 具有更低的总体医疗成本和更高的 QALYs。本研究受到中国人群缺乏长期疗效数据以及缺乏全面的真实世界高质量成本数据的限制。

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