B. C. Lattrell, D. Abendroth

Abstract

Aim/Background: In comparison to dialysis renal transplantation improves life quality and saves costs. However, complications after renal transplantation are associated with additional costs, and about 70% of the aftercare costs are due to immunosuppression. Aim of this investigation was to verify whether the use of well-priced generic formulations of the critical-dose drug cyclosporine is an effective approach for cost-reduction.

Material/Methods: In a prospective pilot study with 12 adult renal transplant recipients the bioavailability of the generic cyclosporine formulation Cicloral® was compared to the original preparation Sandimmun® Optoral during the early postoperative phase. Patients were initially adjusted to the generic formulation. Three weeks thereafter, they were switched to the original preparation. Recorded data for cost evaluation were: daily dose, specific dosage, C0- and C2-levels and concomitant immunosuppression.

Results: Within the conversion period in week 3 and 4 the mean dose was reduced from 6.83 to 5.93 mg/kg body weight. Anyhow, switching to the original compound caused an increase of the cyclosporine blood levels. In spite of the low number of patients included, the most relevant peak level (C2 level) increased significantly from 1.067 µg/ml up to 1.189 (p<0.01). Although the generic formulation is remarkably cheaper than the original drug, the mean daily medication costs with the original drug were 7.98% lower than those with the generic formulation.

Discussion/Conclusion: In case of the drug cyclosporine, the legal bioequivalence criteria are inadequately. Studies with healthy volunteers and stable renal transplant recipients also evidence relevant differences in bioavailability and therapeutic efficacy between generic formulations and the original drug. A savings potential could not be determined by the use of the cyclosporine generic Cicloral®. In addition, reduced safety and an increased need for monitoring might result in additional costs. The problem will come to a head with the introduction of additional generic cyclosporine formulations, because no legal regulations exist obligating to examine the interchangeability of different generic formulations.

Key words: renal transplantation, costs, cost-effectiveness, cyclosporine, generic, bioequivalence, therapeutic equivalence

Barbara Lattrell

Poststr. 2

92348 Berg-Sindlbach

E-Mail: barbara.lattrell@bitte-keinen-spamnovartis.com