Anemia in chronic kidney disease: an opportunity and challenge for disease management.

IN THIS ISSUE OF DISEASE MANAGEMENT, Moyneur et al report on the economic impact of epoetin alpha (EPO) in anemic patients with chronic kidney disease (CKD). During the past year, the topic of anemia management in the CKD and dialysis populations has played out on the national stage, largely fueled by the publication of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study in the New England Journal of Medicine.1 This study triggered concerns that maintaining patients at higher hemoglobin levels (13.5g/dL vs. 11.3g/dL) poses increased risk of cardiovascular morbidity and death. The United States House of Representatives’ Committee on Ways and Means later called a hearing during which officials from the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services were strongly urged to take action to ensure that patients are treated safely and efficiently.2 The FDA issued an alert about erythropoietin stimulating agents (ESAs), calling for prescribers to maintain the lowest hemoglobin necessary to avoid transfusion and recommending that the dose be withheld if the hemoglobin exceeds 12g/dL or increases by 1g/dL in any 2-week period.3 Recently, the FDA’s Cardiovascular and Renal Drugs Advisory Committee and Drug Safety & Risk Management Advisory Committee reviewed ESA dosing and recommended that the FDA not lower the hemoglobin target to 11g/dL for patients not receiving hemodialysis.4 Committee members’ opinions as to what the target should be in the non-dialysis population varied, with some suggesting 10-11g/dL and others recommending 10.5–11.5 or 10–12 g/dL. The Committee also discussed the issue of ESA hypo-responsiveness and underscored the importance of defining this population. From a disease management (DM) perspective, maintaining the hemoglobin level at 12g/dL (but not less than 10g/dL per EPO labeling) can be challenging. Small increases or decreases in EPO doses, insufficient iron stores, and/or changing clinical status can result in underor overshooting the target. Yet, the findings from CHOIR and recent FDA recommendations underscore the need for clinicians and DM providers to examine these patients and implement guidelines to improve the quality and efficiency of their care. Although major dialysis chains have implemented their own guidelines, a recent study published by Thamer et al in the Journal of the American Medical Association reported that large, for-profit dialysis chains used more EPO than not-for-profit centers (on average, 3306 units more of EPO per patient per week).5 The CKD population (which receives anemia treatments in medical offices and clinics) was outside the scope of this study, but the amount of EPO administered to these patients is worth examination.