Investigating the health-economic profiles of biomarker-driven immunosuppresion (BIO-DrIM) following solid organ transplantation
Journal Title: Advances in Precision Medicine - Year 2016, Vol 1, Issue 1
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.
Authors and Affiliations
Simon Anton Weber, Malte Pietzsch, Oriol Bestard, Josep M Grinyo, Ondrej Viklicky and Petra Reinke
Personalized medicine: consequences for drug research and therapy
In drug research, a serious transformation has taken place. With increasing knowledge gained from molecular medicine, it became possible to refine and develop new therapies based on the molecular mechanisms of diseases....
The role of open innovation in biomarker discovery
Precision medicine aims to treat diseases with special consideration for the individual biological variability. Novel biomarkers (BM) are needed to predict therapeutic responses and to allow for the selection of suitable...
What makes a good biomarker?
The last decade has seen an extraordinary amount of effort devoted in biomedical research to the field of biomarkers. There have been some notable successes with novel markers being adopted into clinical practice bringin...
Collaboration for success: the value of strategic collaborations for precision medicine and biomarker discovery
Precision medicine aims to provide the precise treatment for the patient with the right dose at the right point of time. Biomarkers (BM) are vital for the identification of patients who would benefit the most from indivi...
Investigating the health-economic profiles of biomarker-driven immunosuppresion (BIO-DrIM) following solid organ transplantation
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. O...