Evaluating targets and costs of treatment for secondary hyperparathyroidism in incident dialysis patients: the FARO-2 study

Abstract

Daniela Paola Roggeri,1 Mario Cozzolino,2 Sandro Mazzaferro,3 Diego Brancaccio,4 Ernesto Paoletti,5 Alessandro Roggeri,1 Anna Maria Costanzo,6 Umberto di Luzio Paparatti,6 Vincenzo Festa,6 Piergiorgio Messa7 1ProCure Solutions, Nembro, Bergamo, 2Department of Health Sciences, University of Milan, Milan, 3Department of Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences, Sapienza University of Rome, Rome, 4Dialysis Unit NephroCare Simone Martini, Milan, 5Department of Nephrology, San Martino Hospital, Genoa, 6AbbVie Italy, Campoverde, Latina, 7Nephrology, Dialysis and Renal Transplant, Fondazione Ca Granda IRCCS Policlinico, Milan, Italy  On behalf of the FARO Study Group Background: The aim of this analysis was to estimate biochemical parameters and the costs of treatment of secondary hyperparathyroidism (SHPT) in a subpopulation of the FARO-2 study. Methods: The FARO-2 observational study aimed at evaluating the patterns of treatment for SHPT in naïve hemodialysis patients. Data related to pharmacological treatments and biochemical parameters (parathyroid hormone [PTH], calcium, phosphate) were recorded at entry to hemodialysis (baseline) and 6 months later (second survey). The analysis was performed from the Italian National Health Service perspective. Results: Two prominent treatment groups were identified, ie, one on oral calcitriol (n=105) and the other on intravenous paricalcitol (n=33); the intravenous calcitriol and intravenous paricalcitol + cinacalcet combination groups were not analyzed due to low patient numbers. At baseline, serum PTH levels were significantly higher in the intravenous paricalcitol group (P<0.0001). At the second survey, the intravenous paricalcitol group showed a higher percentage of patients at target for PTH than in the oral calcitriol group without changing the percentage of patients at target for phosphate. Moreover, between baseline and the second survey, intravenous paricalcitol significantly increased both the percentage of patients at target for PTH (P=0.033) and the percentage of patients at target for the combined endpoint PTH, calcium, and phosphate (P=0.001). The per-patient weekly pharmaceutical costs related to SHPT treatment, erythropoietin-stimulating agents and phosphate binders accounted for 186.32€ and 219.94€ at baseline for oral calcitriol and intravenous paricalcitol, respectively, while after 6 months, the costs were 180.51€ and 198.79€, respectively. Either at the beginning of dialysis or 6 months later, the total cost of SHPT treatment was not significantly lower in the oral calcitriol group compared with the intravenous paricalcitol group, with a difference among groups that decreased by 46% between the two observations. The cost of erythropoietin stimulating agents at the second survey was lower (−22%) in the intravenous paricalcitol group than in the oral calcitriol group (132.13€ versus 168.36€, respectively). Conclusion: Intravenous paricalcitol significantly increased the percentage of patients at target for the combined endpoint of PTH, calcium, and phosphate (P=0.001). The total cost of treatment for the patients treated with intravenous paricalcitol 6 months after entry to dialysis was not significantly higher than the cost for patients treated with oral calcitriol. Keywords: cost consequences analysis, therapeutic costs, outcomes, SHPT treatments, secondary hyperparathyroidism