Aranesp darbepoetin alfa regulatory update

The Centers for Medicare & Medicaid Services made a final decision to not issue a National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs) to treat anemia in patients with chronic kidney disease (CKD). The decision reiterates a March proposal in which the agency said it identified no trials that were of sufficient design, duration and power to definitely determine that ESAs provided clinical benefits other than increasing hemoglobin (see BioCentury, March 21). ...