Economic evaluation of the personalisation of immunosuppressive therapy in kidney transplantation by means of an in vitro diagnostic test (Immunobiogram®) in Spain

Abstract

Objective: Immunobiogram (IMBG) is an in vitro diagnostic immune function bioassay that evaluates the pharmacodynamic immune response profile of each patient to individual immunosuppressants (IMS) in renal transplant. The objective was to estimate the potential economic and health impact of the use of IMBG for the Spanish National Health System (NHS). Methods: The evolution of a cohort of patients with kidney transplantation at least 1 year after transplantation (time horizon of 5 years) was simulated using a second-order Monte Carlo simulation for two scenarios: renal failure in patients with high immunological risk (HR), and adverse events (AE) in stable patients (non-HR). The transition probabilities were obtained from a clinical study with IMBG and a systematic review. The cost associated with graft failure (dialysis, re-transplantation), IMS and AE management were obtained from Spanish sources. Results: IMS adjustment, according to the IMBG could contribute to a risk reduction of graft failure with a saving per HR patient of €20,263 (95% CI €17,520-23,678) (100% saving probability). The expected reduction in the AE rate would generate savings per non-HR patient of €1,409 (95% CI €41-3,316) (97.8% saving probability). Compared with the option of not using IMBG, 0.5256 (95% CI 0.3388, 0.7452) years of life and 0.0219 (95% CI 0.0115; 0.0356) quality-adjusted life years (QALY) would be gained in each patient evaluated with IMBG. Conclusions: IMBG could contribute to a risk reduction of graft failure and AEs related with IMS, with gain in years of life and QALY, as well as with considerable savings for the NHS. Key words: diagnosis; Immunobiogram; kidney transplantation; personalized medicine; rejection.