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

2016 ◽  
Vol 1 (1) ◽  
pp. 48 ◽  
Author(s):  
Simon A Weber ◽  
Malte Pietzsch ◽  
Oriol Bestard ◽  
Josep M Grinyo ◽  
Ondrej Viklicky ◽  
...  

Immunosuppression (IS) following solid organ transplantation is indicated to avoid rejection but puts a sig-nificant burden on patients and healthcare systems due to life-long medication dependency and associated costs. Or-gan-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 exam-ple. 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. Develop-ers of biomarker tests should stress the importance of integrating health-economic evaluations early into prod-uct-development.

2010 ◽  
Vol 90 ◽  
pp. 729
Author(s):  
W. Sommer ◽  
A. R. Simon ◽  
G. Warnecke ◽  
A. Schwarz ◽  
H. Barg-Hock ◽  
...  

2021 ◽  
Vol 11 ◽  
Author(s):  
Manuel Alfredo Podestà ◽  
Giuseppe Remuzzi ◽  
Federica Casiraghi

Transplantation is the gold-standard treatment for the failure of several solid organs, including the kidneys, liver, heart, lung and small bowel. The use of tailored immunosuppressive agents has improved graft and patient survival remarkably in early post-transplant stages, but long-term outcomes are frequently unsatisfactory due to the development of chronic graft rejection, which ultimately leads to transplant failure. Moreover, prolonged immunosuppression entails severe side effects that severely impact patient survival and quality of life. The achievement of tolerance, i.e., stable graft function without the need for immunosuppression, is considered the Holy Grail of the field of solid organ transplantation. However, spontaneous tolerance in solid allograft recipients is a rare and unpredictable event. Several strategies that include peri-transplant administration of non-hematopoietic immunomodulatory cells can safely and effectively induce tolerance in pre-clinical models of solid organ transplantation. Mesenchymal stromal cells (MSC), non-hematopoietic cells that can be obtained from several adult and fetal tissues, are among the most promising candidates. In this review, we will focus on current pre-clinical evidence of the immunomodulatory effect of MSC in solid organ transplantation, and discuss the available evidence of their safety and efficacy in clinical trials.


2010 ◽  
Vol 57 (2) ◽  
pp. 559-574 ◽  
Author(s):  
Samantha J. Anthony ◽  
Stacey Pollock BarZiv ◽  
Vicky Lee Ng

2016 ◽  
Vol 100 (3) ◽  
pp. 613-629 ◽  
Author(s):  
Swati Rao ◽  
Mythili Ghanta ◽  
Michael J. Moritz ◽  
Serban Constantinescu

2007 ◽  
Vol 21 (3) ◽  
pp. 155-170 ◽  
Author(s):  
Francisco Ortega ◽  
Covadonga Valdés ◽  
Teresa Ortega

2020 ◽  
Vol 36 (4) ◽  
pp. 380-387
Author(s):  
Sarah Fontenay ◽  
Lionel Catarino ◽  
Soumeya Snoussi ◽  
Hélène van den Brink ◽  
Judith Pineau ◽  
...  

ObjectiveBecause of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.MethodsA systematic review was performed using four electronic databases to identify health economic evaluation studies dealing with VADs. The methodological quality and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.ResultsOf the 1,258 publications identified, thirteen articles were included in this review. Twelve studies were cost–utility analyses and one was a cost-effectiveness analysis. According to the Cooper hierarchy scale, the quality of the data used was heterogeneous. The level of evidence used for clinical effect sizes, safety data, and baseline clinical data was of poor quality. In contrast, cost data were of high quality in most studies. Quality of reporting varied between studies, with an average score of 17.4 (range 15–19) according to the CHEERS checklist.ConclusionThe current study shows that the quality of clinical data used in economic evaluations of VADs is rather poor in general. This is a concern that deserves greater attention in the process of health technology assessment of medical devices.


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