Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis

CMS received a formal request for a national coverage determination (NCD) for recombinant human erythropoietin (ESAs) for treatment of chronic kidney disease (CKD) and dialysis-related anemia.

Medicare has historically made payment for ESAs for particular indications with specific conditions. Erythropoiesis Stimulating Agents (ESAs) are drugs or biologic agents which interact with the erythropoietin receptor or its pathway. The most common of these are recombinant (genetically man-made) forms of the native protein, human erythropoietin, or analogues (modified forms) of the native protein. Because ESAs stimulate the bone marrow to make erythrocytes (red blood cells), ESAs have been used to treat anemia.

Anemia, which has multiple causes, is not uncommon in some patient populations, such as those with chronic renal disease. Emerging data have suggested that ESA use may be associated with decreased survival and increased morbidity in both renal and non-renal patient populations.

ESAs have FDA approved labeling that includes boxed warnings citing greater risks for death, serious cardiovascular events, and stroke in some chronic renal failure populations. The requestor points to recent clinical studies that have shown significant ESA-related adverse safety signals and asks CMS to establish coverage limitations for ESA use in both pre-dialysis and dialysis renal disease patient populations.

Some parties have suggested that prior ESA use may predict the long term success of subsequent kidney transplantation in patients with chronic kidney disease. We are commissioning a technology assessment from an outside entity.

June 16, 2010

October 26, 2010

March 16, 2011

June 16, 2011