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

Abstract

Investigating the health-economic profiles of biomarker-driven immunosuppresion (BIO-DrIM) following solid organ transplantation. © 2016 Simon Anton Weber, et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 66 RESEARCH ARTICLEInvestigating the health-economic profiles of biomarker-driven immunosuppresion (BIO-DrIM) following solid organ transplantation Abstract: 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. Keywords: transplantation, immunosuppression, biomarker, individualized medicine, cost-effectiveness, cost-utility, micro-costing *Correspondence to: Simon Anton Weber, Berlin-Brandenburg Center for Regenerative Therapies, Charité Universitätsmedizin Berlin, Germany; Email: simon.weber@cellogic.de

Pre-existing Alloreactive T and B Cells and Their Possible Relevance for Pre-transplant Risk Estimation in Kidney Transplant Recipients

“…In this regard, IFN-γ producing alloreactive T cell frequencies of the direct pathway as measured by ELISPOT could be a good assay candidate to be used in practice. However, the actual predictive value per individual patient needs to be determined by well-characterized large scale studies, such as the BIO-DrIM consortium (114). Moreover, the need for donor cells in addition to the fact that IFN-γ ELISPOT can only be used to screen patients for living-donor transplantations due to the time consumed to perform the assay are the obstacles in the way of its use.…”