Chronic use of calcineurin inhibitors has been associated with cardiovascular (CV) toxicity and nephrotoxicity in kidney transplant recipients (KTR). Belatacept (bela) is associated with lower rates of CV and nephrotoxicity at an increased cost. The purpose of this study is to determine if the higher immediate cost of a bela-based regimen in KTR is justified by the overall decreased rate of CV and nephrotoxicity.

Methods: This evaluation compared a bela-based regimen to a tacrolimus (FK)-based regimen, utilizing the same induction and maintenance therapy from a Medicare perspective. The target population included adult, EBV +, low-to-moderate immunologic risk, primary standard-donor KTRs. A Markov simulation was created using TreeAge 2012 software and run for 3 cycles, each representing one year. The model assessed nephrotoxicity via progression to dialysis as a proxy for graft loss and acute rejection episodes. New onset diabetes after transplantation (NODAT) was used as a surrogate for CV risk assuming that the all cause death node would capture CV mortality. The primary endpoint was cost per death averted with the bela-based regimen. Historical cost data were adjusted to 2011 US dollars and future costs were discounted at 3%. A sensitivity analysis using Monte Carlo simulation was run for 10,000 trials. Variables associated with the decision nodes (e.g. NODAT, acute rejection) were triangularly distributed across a range of values that encompassed the best and worst case scenario for that particular node based on available data.

Results: The 3 year cumulative costs of the bela-based regimen were $147,876 per pt with 954 pts surviving. The 3 year cumulative costs of the FK-based regimen were $106,803 per pt with 870 pts surviving. Thus, the incremental cost-effectiveness ratio (ICER) was $489 per death averted. The Monte Carlo simulation produced mean costs per pt for each regimen. The bela arm accrued a mean cost of $180,274 per pt with 934 pts surviving. The FK arm accrued $125,226 per pt with 883 pts surviving. The ICER for the Monte Carlo simulation was $1079 per death averted.

Conclusion: Based on this economic evaluation, the cost per death averted was $489. In comparison to the high cost of caring for a pt post transplant, this additional expenditure seems trivial. True differences in costs and outcomes will become clearer as data from additional bela trials emerge.

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