Background: Significant challenges exist to detecting kidney injury early in patients with kidney transplants. The current standard of care includes monitoring serum creatinine levels and immunosuppressive drug levels, both of which are poor early predictors of kidney graft damage. Protocol (surveillance) biopsies provide an accurate assessment of the transplanted kidney but are expensive, invasive, risking infection and bleeding and even graft loss, such that they are unsuited for frequent monitoring. Objectives: An economic analysis was performed to assess the economic impact of replacing protocol biopsies with blood molecular gene profiling in kidney transplant recipients. Methods: For the economic analysis, we utilized CMS fee schedule data, actual patient billing examples and published literature to estimate the per-patient tested savings of replacing protocol biopsies with the TruGraf blood test to monitor kidney transplant recipients. Results: The TruGraf test provides a net savings of $1,302 per patient per year, including the TruGraf test costs. In 2016, 19,060 kidney transplants were performed; replacing protocol biopsies with TruGraf testing could save $24.8 million in direct treatment costs per year. Conclusions: Use of the TruGraf blood test could spare patients unnecessary protocol biopsies. The healthcare system will realize significant economic benefits; in addition, the ability to intervene early with therapies to fend off clinical acute rejection may provide the added benefit of improving long term outcomes.
Roy First M1,2*, Darren Lee2, Peter Lewis2 and Stan Rose2
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