Abstract

Chronic kidney disease (CKD) is a growing public health issue worldwide. Erythropoiesis stimulating agents (ESAs) are used to treat CKD-related anemia, contributing to CKD management costs. However, 20-30% of ESA costs can be reduced using biosimilars. Our objective was to investigate direct healthcare costs of CKD patients treated with originator or biosimilar ESAs and potential savings achievable by increasing use of biosimilars. A multi-center, retrospective (2009-2014), cohort study was conducted using claims databases of five large geographic areas in Italy (8 million residents). Incident CKD-ESA users with at least 1-year ESA use, were included in the study. Yearly mean/patient direct healthcare costs were estimated, by CKD stage. Total annual cost and potential savings due to ESA use were estimated considering 25%, 50% and 75% of ESA substitution with biosimilar epo-alpha. During the study period 7,810 CKD patients started ESA treatment (epo-alfa reference product: 1,139, 14.6%; epo-alfa biosimilars: 1,204, 15.4%; other still patented ESAs: 5,467, 70.0%). Of these, 2,921 (37.4%) had information on CKD stage (I-III: 40%; IV-V: 27%; dialysis: 33%). ESA-related annual mean cost/patient represented 17% (€1,551; 95% Confidence Interval €1,471-€1,631) of total cost/year in stage I-III, decreasing to 13% (€1,493; €1,413-€1,573) in stage IV-V and 6% (€2,045; €1,946-€2,144) in dialysis patients. 15% of incident ESA users, started ESA biosimilar during the study period (mean ESA cost/patient/year: €1,051). Among ESA-originator users, assuming 25% biosimilar uptake, the annual cost-saving on ESA treatment would represent 10.5% of total ESA costs in CKD stage I-V and 7.7% in dialyzed patients. Assuming 75% biosimilar uptake cost-savings would increase to 31.5% in CKD stage I-V and 23.0% in dialysis. CKD patients management, especially after initiation of dialysis, is very costly. ESA use contributes partially to the direct healthcare costs of CKD. Larger use of ESA biosimilars would substantially reduce drug expenditure in CKD patients.

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