Medicare reviews ESAs after FDA warning

Medicare announced a national coverage analysis on the use of erythropoiesis stimulating agents (ESAs) for the conditions other than end-stage renal disease, the first step toward issuing a national coverage determination.

Medicare is also reviewing its erythropoietin monitoring policy for patients with end-stage kidney disease, and who are dialyzed in renal facilities.

“We will review the scientific evidence to determine the appropriate use of ESAs for multiple clinical indications. It is important to provide the correct coverage of ESAs for each specific clinical indication,” said Barry Straube, chief medical officer for Medicare.

The drugs under review are Epogen and Aranesp, marketed by Amgen, and Procrit, from Johnson & Johnson. They are man-made versions of erythropoietin, a hormone that is produced in the kidney and stimulates the bone marrow to make more red blood cells.

The FDA recently updated the safety information for these products after studies cast doubt on their safety. The regulator added a “black box” warning to the drug labels, the strongest warning that can be given to prescription drugs in the US.