The Impact of ESA Use on Renal Transplant Graft Survival

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=57 | meeting_date=2011-01-19

Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis: The Impact of ESA Use on Renal Transplant Graft Survival CMS has called this meeting of the panel to review the available evidence on the use of erythropoiesis stimulating agents (ESAs) to affect renal (kidney) transplant graft survival in patients who have both chronic kidney disease (CKD) and anemia. Some parties claim that prior ESA use may predict the long term success of subsequent renal transplantation in patients with CKD. Medicare currently does not have a national coverage determination for the use of ESAs for anemia in patients who have CKD. Medicare has historically made payment for ESAs for particular indications with specific conditions. 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 CKD. ESAs have FDA approved labeling that includes boxed warnings citing greater risks for death, serious cardiovascular events, and stroke in patients with chronic renal failure.