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WIREs Syst Biol Med
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A practical model for economic evaluation of tissue‐engineered therapies

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Tissue‐engineered therapies are being developed across virtually all fields of medicine. Some of these therapies are already in clinical use, while others are still in clinical trials or the experimental phase. Most initial studies in the evaluation of new therapies focus on demonstration of clinical efficacy. However, cost considerations or economic viability are just as important. Many tissue‐engineered therapies have failed to be impactful because of shortcomings in economic competitiveness, rather than clinical efficacy. Furthermore, such economic viability studies should be performed early in the process of development, before significant investment has been made. Cost‐minimization analysis combined with sensitivity analysis is a useful model for the economic evaluation of new tissue‐engineered therapies. The analysis can be performed early in the development process, and can provide valuable information to guide further investment and research. The utility of the model is illustrated with the practical real‐world example of tissue‐engineered constructs for corneal endothelial transplantation. WIREs Syst Biol Med 2015, 7:91–100. doi: 10.1002/wsbm.1292 This article is categorized under: Translational, Genomic, and Systems Medicine > Translational Medicine
Production of a tissue‐engineered therapy. Schematic depicting the common stages in the production of a tissue‐engineered therapy.
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One‐way sensitivity analysis. One‐way sensitivity analysis of selected variables on the cost advantage of the tissue engineering strategy over the procured‐tissue strategy. ‘+’ indicates that the cost advantage increases as that variable increases, while ‘−’ indicates that the cost advantage decreases as that variable increases. GMP, good manufacturing practice; QA, quality assurance. (Reprinted with permission from Ref 31. Copyright 2014 PLOS)
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Overview of corneal endothelial transplantation strategies. Overview of the tissue engineering strategy (in blue) and the procured‐tissue strategy (in red). GMP, good manufacturing practice; QA, quality assurance; ALTK, automated lamellar therapeutic keratoplasty; EK, endothelial keratoplasty. (Reprinted with permission from Ref 31. Copyright 2014 PLOS)
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