Investigating the health-economic profiles of biomarker-driven immunosuppresion(BIO-DrIM)following solid organ transplantation  

作　　者：Simon Anton Weber Malte Pietzsch Oriol Bestard Josep M Grinyo Ondrej Viklicky Petra Reinke 

机构地区：[1]Berlin-Brandenburg Center for Regenerative Therapies,Charite Universitatsmedizin Berlin,Germany [2]Cellogic GmbH,Berlin,Germany [3]IDIBELL,Hospital Universitari de BELLVITGE,Barcelona,Spain [4]Department of Nephrology,Institute for Clinical and Experimental Medicine,Prague,Czech Republic [5]Department of Nephrology and internal intensive Care,Charite Universitatsmedizin Berlin,Germany

出　　处：《Advances in Precision Medicine》2016年第1期66-77,共12页精准医疗前沿

基　　金：supported by the FP7 EU consortium BIO-DrIM.

摘　　要：Immunosuppression(IS)following solid organ transplantation is indicated to avoid rejection but puts a significant burden on patients and healthcare systems due to life-long medication dependency and associated costs.Organ-tolerance with low or no IS medication has been observed,and might be forecasted with the help of appropriate biomarkers.Individualized treatments raise the question whether benefits of individualization outweigh the costs of stratification.This article outlines the importance of early economic evaluation in the context of biomarker-guided IS and discusses challenges that an economic evaluation should address,using the BIO-DrIM project as a reference example.We report on design aspects and health-economic study integration into several newly designed biomarker trials.In these studies,health-economic endpoints were defined to measure benefits of individualization and to compare them to the costs associated with stratification.Key economic outcomes to be collected are resource consumption and patient quality of life.Test accuracy of the biomarker-stratification is critical for the clinical success and the health-economic viability of an individualized reduced IS regime.However,IS regimes are not well standardized,rendering comparator choice difficult.The multi-national character of the trials adds further complexity that needs to be addressed.Developers of biomarker tests should stress the importance of integrating health-economic evaluations early into product-development.

关 键 词：TRANSPLANTATION IMMUNOSUPPRESSION BIOMARKER individualized medicine COST-EFFECTIVENESS COST-UTILITY micro-costing 

分 类 号：R73[医药卫生—肿瘤]