CMS has called this meeting of the panel to review the available evidence on the use of erythropoiesis stimulating agents (ESAs) to manage anemia in patients who have chronic kidney disease (CKD). Medicare currently does not have a national coverage determination for the use of ESAs for anemia in patients who have CKD. ESAs are synthetic analogs of the hormone erythropoietin.
Anemia is prevalent in patients with kidney disease and is more common as CKD progressively worsens. Recombinant genetic technologies are used to produce the ESAs that are commonly used to treat anemia in CKD patients. ESAs raise hemoglobin and hematocrit levels in anemic patients who have CKD, including both those on dialysis and those who do not require dialysis.
ESAs were introduced in 1989 and initially administered usually only to patients at risk for blood transfusions. During the subsequent 20 years, ESA use increased, resulting in the common practice of administering ESAs to CKD patients who have anemia, but not necessarily only to those who are at risk for transfusion. Currently, over 95% of end stage renal disease (ESRD) patients receive ESAs. It is unclear how many pre-ESRD CKD patients receive ESAs for anemia.
In the fall of 2006 through winter 2007, a succession of published reports highlighted the dangers, including increased mortality, associated with the use of ESAs. These were in addition to other danger signals seen since the introductions of ESAs in 1989. These findings, based on the results of clinical trials, were followed by a series of changes including boxed warnings in the FDA approved labeling for ESAs and a “Dear Doctor Letter” regarding concerns about the safety of ESAs.