他克莫司与微乳化环孢素的成本效益:肾移植结局的10年模型

The cost effectiveness of tacrolimus versus microemulsified cyclosporin: a 10-year model of renal transplantation outcomes.

作者信息

Orme Michelle E, Jurewicz Wieslaw A, Kumar Nagappan, McKechnie Tracy L

机构信息

The Lewin Group, Bracknell, UK.

出版信息

Pharmacoeconomics. 2003;21(17):1263-76. doi: 10.2165/00019053-200321170-00003.

Abstract

INTRODUCTION AND OBJECTIVE

In 1983, the launch of cyclosporin was a significant clinical advance for organ transplant recipients. Subsequent drug research led to further advances with the introduction of cyclosporin microemulsion (cyclosporin ME) and tacrolimus. This paper presents the results from a long-term model comparing the clinical and economic outcomes associated with cyclosporin ME and tacrolimus immunosuppression for the prevention of graft rejection following renal transplantation.

STUDY DESIGN

A model was developed to project the costs and outcomes over a 10-year period following transplantation. The model was based on the results of a prospective, randomised study of 179 renal transplantation recipients receiving either cyclosporin ME or tacrolimus, which was conducted by the Welsh Transplantation Research Group (median follow-up: 2.7 years).

METHODS

The short-term costs and outcomes were the averages from the actual head-to-head trial data. From this, the long-term costs and outcomes were extrapolated based on the rate of change in patient and graft survival at 3, 5 and 10 years post transplant, as reported in the 1995 United Kingdom Transplant Support Service Authority Renal Transplant Audit. PERSPECTIVE AND YEAR OF COST DATA: The analysis was conducted from the perspective of a UK transplant unit. Costs were at 1999 prices (pounds sterling 1 = dollars US 1.42 = Euro 1.5) and costs and outcomes were discounted at 6% and 1.5%, respectively.

RESULTS

The model estimated that 10 years after transplantation, the proportion of patients surviving was 56% of the cyclosporin ME cohort and 64% of the tacrolimus cohort. The cumulative cost of maintenance therapy at 10 years was pounds sterling 23204 per patient maintained on cyclosporin ME versus pounds sterling 23803 per patient on tacrolimus. The cost per survivor at 10 years was pounds sterling 37000 (tacrolimus) versus pounds sterling 41000 (cyclosporin ME) and the cost per patient with a functioning graft was pounds sterling 39000 versus pounds sterling 45000. A Monte Carlo simulation of the model (10000 simulations) gave an average cost at 10 years of pounds sterling 23279 (SD pounds sterling 3457) for cyclosporin ME and pounds sterling 22841 (SD pounds sterling 3590) for tacrolimus. A (second order) probabilistic sensitivity analysis was also performed. The average cost at 10 years from a simulated cohort of 1000 was pounds sterling 23473 (SD pounds sterling 2154) for cyclosporin ME and pounds sterling 24087 (SD pounds sterling 2025) for tacrolimus.

CONCLUSION

Renal transplant recipients maintained on tacrolimus have better short- and long-term outcomes than patients maintained on cyclosporin ME. The long-term use of tacrolimus is a more cost-effective solution in terms of the number of survivors, patients with a functioning graft and rejection-free patients.

摘要

引言与目的

1983年,环孢素的推出是器官移植受者临床治疗的一项重大进展。随后的药物研究随着环孢素微乳剂(环孢素ME)和他克莫司的引入取得了进一步进展。本文展示了一个长期模型的结果,该模型比较了环孢素ME和他克莫司免疫抑制在预防肾移植后移植物排斥反应方面的临床和经济结果。

研究设计

开发了一个模型来预测移植后10年期间的成本和结果。该模型基于威尔士移植研究小组对179名接受环孢素ME或他克莫司治疗的肾移植受者进行的一项前瞻性随机研究结果(中位随访时间:2.7年)。

方法

短期成本和结果是实际头对头试验数据的平均值。据此,根据1995年英国移植支持服务管理局肾移植审计报告中移植后3年、5年和10年患者及移植物存活率的变化率推断长期成本和结果。

成本数据的视角与年份

分析是从英国一个移植单位的视角进行的。成本以1999年的价格计算(1英镑 = 1.42美元 = 1.5欧元),成本和结果分别按6%和1.5%进行贴现。

结果

该模型估计,移植后10年,环孢素ME组存活患者的比例为56%,他克莫司组为64%。10年维持治疗的累积成本为,接受环孢素ME治疗的患者每人23204英镑,接受他克莫司治疗的患者每人23803英镑。10年时每名存活者的成本为,他克莫司组37000英镑,环孢素ME组41000英镑;每名有功能移植物患者的成本为,他克莫司组39000英镑,环孢素ME组45000英镑。对该模型进行蒙特卡洛模拟(10000次模拟)得出,10年时环孢素ME的平均成本为23279英镑(标准差34英镑),他克莫司为22841英镑(标准差35英镑)。还进行了(二阶)概率敏感性分析。从1000名模拟队列得出的10年平均成本为,环孢素ME组23473英镑(标准差2154英镑),他克莫司组24087英镑(标准差2025英镑)。

结论

接受他克莫司维持治疗的肾移植受者比接受环孢素ME治疗的患者有更好的短期和长期结果。就存活者数量、有功能移植物患者数量和无排斥反应患者数量而言,长期使用他克莫司是一种更具成本效益的解决方案。

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