End-stage renal disease costs for patients new to hemodialysis in Italy: The FARO-2 Study

Background: Increasing incidence and prevalence of end-stage renal disease (ESRD) together with the presence of several comorbidities in chronic kidney disease patients (CKD) could be associated with a relevant economic burden. Aim: The aim of this analysis was to estimate the direct healthcare costs of ESRD and its major comorbidities in Italian patients who were naïve to hemodialysis (HD) recruited for the FARO-2 study. Methods: The FARO-2 study was a retrospective observational study conducted in Italy that evaluated the patterns of treatment of secondary hyperparathyroidism (SHPT) and related costs in patients naïve to HD. The observational period was 2006–2008. Costs were measured in Euros (reference year: 2008). Resource use for the first 2 periods of 6 months of HD was monetized, with reimbursement calculated for SHPT drugs, phosphate binders, and erythropoietin-stimulating agents (ESAs); HD sessions; and hospitalizations due to ESRD and its major comorbidities. The analysis was performed by the Italian National Health Service (INHS) perspective. Results: 567 patients were observed for at least 2 periods of 6 months. During the first 12 months after the initiation of HD, average direct healthcare costs were assessed using the percentage of patients treated and the average daily dosages (for drugs), the percentage of patients hospitalized and the types of hospitalizations (for inpatients), and the average weekly frequency of HD sessions. Total per-patient yearly costs totaled 34,789.9 €: HD accounted for 66.1% of expenditures, with hospitalizations and drugs accounting for 12.9% and 21.0% of expenditures, respectively (including 17.1% for ESAs). Conclusions: Patients naïve to HD have a significant impact on Italian National Health Service expenditures, although only the costs related to treatment of ESRD and its comorbidities were calculated in the present study. The major cost drivers were HD and ESAs, while SHPT drugs and phosphate binders together accounted for only 3.9% of direct healthcare expenditures.