A randomized controlled trial of costs associated with anemia therapy in hemodialysis patients treated with intravenous darbepoetin alfa versus intravenous epoetin alfa

Woodland, Andrea Lynn (2013) A randomized controlled trial of costs associated with anemia therapy in hemodialysis patients treated with intravenous darbepoetin alfa versus intravenous epoetin alfa. Masters thesis, Memorial University of Newfoundland.

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Abstract

Anemia of Chronic Kidney Disease is associated with adverse cardiovascular and clinical outcomes and a reduced quality of life. Erythropoiesis stimulating agents (ESAs) have improved anemia management and two agents are available in Canada, epoetin alfa (Eprex®) and darbepoetin alfa (Aranesp®). Darbepoetin requires less frequent administration due to a longer half-life. Epoetin and darbepoetin are considered to be equally effective in achieving target hemoglobin in dialysis patients but it is not clear if there is a cost difference. There have been few head-to-head comparisons of the two ESAs; most published data is from observational switch studies. -- An open label randomized controlled trial of intravenous darbepoetin alfa versus epoetin alfa was conducted in hemodialysis patients. Fifty patients were enrolled in the study. A dose stabilization run-in phase was followed by a 12 month active phase. ESAs and iron were dosed using a study algorithm to maintain hemoglobin within 100-120g/L. The primary outcome was the cost per patient of ESA over 12 months. Secondary outcomes included deviation from target ranges in anemia indices, iron dose and cost, time and number of dose changes required for dose stabilization, number of dose changes in the active phase and the dose conversion ratio. -- The median cost for epoetin over 12 months was $4179(IQR $2416-5955) and for darbepoetin was $2303(IQR $1178-4219) with a difference of $1876 (p=0.017). There was no significant difference in the dose or cost of iron. The median weekly iron dose was 40.4mg for epoetin and 41.7mg for darbepoetin (p=0.992). There were no significant differences in the anemia care targets including hemoglobin: 108.0g/L epoetin and 109.8g/L darbepoetin (p=0.336); serum ferritin: 848μg/L epoetin and 726μg/L darbepoetin (p=0.202); TSAT: 26.7% epoetin and 28.6% darbepoetin (p=0.472). -- The number of dose changes and the time required to attain hemoglobin stability in the run-in phase and the number of dose changes in the active phase were similar for both groups. The dose conversion ratio was 280:1 (95% CI 197-362:1) at the end of the run-in phase, 360:1 (95% CI 262-457: I) at the 3 month point of the active phase and 382:1 (95% CI 235-529:1) at the 6 month point of the active phase. -- In this study of hemodialysis patients with comparable anemia management, darbepoetin cost $1876 less per year per patient than epoetin. This difference represents a significant cost savings which would be of interest to clinicians, policy makers and payers.

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