Evaluating the Cost-Effectiveness of Prolonged-Release Tacrolimus Relative to Immediate-Release Tacrolimus in Liver Transplant Patients Based on Data from Routine Clinical Practice.

Background: As of 2014, there were approximately 8300 patients with a functioning liver transplant in the UK Transplant Registry, with 880 liver transplants performed in 2013-2014 alone. Tacrolimus, typically used in combination with steroids and mycophenolate mofetil, currently represents the cornerstone of post-transplant immunosuppression in liver transplant recipients.

Objectives: The objective of the present study was to evaluate the cost-effectiveness of prolonged-release (PR) tacrolimus (Advagraf, Astellas Pharma Inc., Tokyo, Japan) versus branded immediate-release (IR) tacrolimus (Prograf, Astellas Pharma Inc., Tokyo, Japan) in liver transplant recipients in the UK.

Methods: A model was developed in Microsoft Excel to estimate costs associated with immunosuppressive medications and retransplantation. Three-year patient and graft survival data were taken from a recent retrospective registry analysis and dose data were taken from prescribing information. Costs in 2014 pounds sterling were taken from the British National Formulary and the National Health Service National Tariff.

Results: Over a 3-year time horizon, the numbers needed to treat with PR tacrolimus relative to IR tacrolimus were 14 to avoid one graft loss and 18 to avoid one death. The model was sensitive to dosing assumptions, with incremental cost estimates varying between a saving of £1642 (standard deviation £885) per patient, assuming the same per-kilogram dosing of PR tacrolimus (Advagraf) and IR tacrolimus (Prograf) and an increase of £1350 (£964) using RCT dose data.

Conclusion: Data from a recent analysis of routine clinical practice data in liver transplant recipients on PR tacrolimus and IR tacrolimus showed significant differences in long-term graft survival in favor of PR tacrolimus. Modeling these data in the UK showed that, over a 3-year time horizon, one graft would be saved for every 14 patients treated with PR tacrolimus with minimal impact on costs when compared with branded IR tacrolimus (Prograf).