OBJECTIVES: Immunobiogram is an IVD bioassay to help physicians to select the most appropriate immunosuppressive drugs (IS) and doses. The objective was to estimate the economic impact of the Immunobiogram use for the Spanish National-Health-System (NHS).

METHODS: A hypothetical cohort (1,000 patients) was modeled 1 year after renal transplantation using a probabilistic second-order Monte Carlo simulation. Two scenarios were considered: graft failure in patients with high immunological risk (HR) and the rate of adverse events (AEs) in stable patients (non-HR). The probabilities of reducing the risk of graft failure by selecting the most effective IS/dose in HR patients with an Immunobiogram resistant profile and reducing the AEs rate due to dose adjustment in patients with an Immunobiogram sensitive profile to the IS they take were obtained from a clinical study with Immunobiogram and from a systematic literature review. For a time horizon of 5 years, it was assumed that one annual assay would be conducted on HR patients and only one assay in total on non-HR patients. The costs associated with graft failure (dialysis, retransplantation), IS therapy and the AEs management were obtained from Spanish sources. All model assumptions were validated by a spanish clinical experts panel.

RESULTS: Immunobiogram use, would entail a risk reduction of graft failure with a saving per HR patient of € 20,279 (95% CI € 17,512-23,105) and a 100% saving probability. The expected reduction in the AE rate would generate savings per non-HR patient of € 3,328 (95% CI € 451-7,957) and a 99.5 saving probability. Considering both populations of renal transplant patients (HR and non-HR), the savings per patient would be € 7,098 (95% CI € 6,129-8,087), with a 99.7% saving probability.

CONCLUSIONS: Immunobiogram would reduce the risk of renal graft failure and AEs associated with IMS, with considerable savings for the Spanish NHS.