Tacrolimus versus cyclosporin in renal transplantation in Italy: cost-minimisation and cost-effectiveness analyses.

BACKGROUND The economic impact of therapies has increasingly become part of the clinical decision-making process. Costs associated with kidney transplantation are substantial and economic evaluations are useful in identifying immunosuppressive regimens that yield optimal clinical and economic benefits. METHODS Utilisation of health care resources during the first 6-months after renal transplantation was examined in 557 kidney transplant recipients participating in a European, multicentre, randomised, parallel group study that compared the efficacy and safety of a tacrolimus-based regimen versus a cyclosporin-microemulsion-based regimen. Cost-minimisation and cost-effectiveness analyses were conducted from an Italian hospital perspective, including direct medical costs only (e.g. medication, hospitalisation). RESULTS The incidence of acute rejection was significantly lower in the tacrolimus group than in the cyclosporin microemulsion (ME) group (32.5% versus 51.3%; p<0.001). Patient and graft survival were similar in both treatment groups. Renal transplant recipients receiving tacrolimus-based immunosuppression had lower utilisation of health care resources and lower total costs per patient than cyclosporin-ME treated patients. When surviving patients with a rejection-free graft were analysed, tacrolimus therapy was cost-saving, since it was both more effective (18.8% difference in the incidence of acute rejection; 95%CI 10.7%-26.8%; p<0.001) and less costly than cyclosporin-ME based therapy (cost difference euro9918). The costs per patient with a functioning graft were euro2305, the costs per surviving patient were euro1892 lower in tacrolimus treated patients. Sensitivity analyses using the key cost-drivers (hospitalisation, study drug, and concomitant medication) found the cost advantage of tacrolimus was maintained. CONCLUSION In the first 6 months after renal transplantation, tacrolimus-based therapy was less costly than cyclosporin-ME based therapy. When surviving patients with a rejection-free graft were considered, tacrolimus was the dominant therapy.