On March 9, 2007, the Food and Drug Administration (FDA) issued a public health safety warning regarding the use of erythropoiesis-stimulating agents (ESAs) which are used for the treatment of anemia. The drugs affected by this warning are darbepoietin alfa (Aranesp®), and darbepoietin alfa (Epogen® and Procrit®). The manufacturers of these products, Amgen and Ortho Biotech LP, have concurred with the FDA and will change their product labels to include the safety warning, the black box warning and new dosing recommendations
The FDA based its recommendations upon the results of two large clinical trials of ESA use in chronic kidney disease. They reported increased risks in patients who were treated with ESAs to target hemoglobins that were higher than the currently recommended hemoglobin concentrations. There also were other clinical trials done with cancer and surgical patients, which bore similar results but had different outcome measures. Based upon the collective evidence, the FDA has stated that it will continue to evaluate the safety of these products based on the results of the recent clinical studies.
The Centers for Medicare & Medicaid Services (CMS) announced, in a press release dated March 14, 2007, that it will be reviewing all Medicare policies regarding the use of ESAs, and specifically its EPO monitoring policy for patients with ESRD, and who are dialyzed in renal facilities.
Testimony before Congress in June 2007 included discussion on whether or not to mandate the route of administration of ESAs. Some studies have suggested subcutaneous, rather than intravenous, administration of ESAs can result in maintaining hemoglobin levels in dialysis patients with lower dosing and similar or better hemoglobin outcomes thereby saving Medicare dollars.
On July 20, 2007, CMS announced it is strengthening its ESA Monitoring Policy (EMP) for claims for ESAs used to treat anemia in Medicare beneficiaries who are receiving dialysis treatment for ESRD. They announced that the penalty for exceeding a hemoglobin of 13 or greater for 3 months or more would result in a 50% reduction in reimbursement and it would be calculated on the first 2 months dosing totals during this period.
ANNA recognizes that use of ESAs has greatly improved the quality of life in persons with chronic kidney disease. For dialysis patients, the use of ESAs has reduced the need for blood transfusions and its associated complications. ANNA understands that nurses, patients, and their families may have questions or concerns about ESA dosing and administration after they hear or read about the FDA public health warning, Congressional testimony and CMS policy announcements. We strongly believe that treatment decisions relating to a patients care should remain with the physician, advanced practice nurse and/or anemia manager. The decision for treatment of anemia of CKD should be based on available scientific evidence, sound clinical judgment, individual medical and psychosocial needs of the patient, type of dialysis modality, in addition to, communication with patients and their family members. ANNA will continue to keep its members informed of any new developments from the FDA or CMS on this issue.
American Society of Nephrology. (2007, March 28). FDA black box (public health) warning on erythropoiesis-stimulating agents (ESAs) (Press Release). Retrieved from http://www.asn-online.org/policy_and_public_affairs/FDA%20BlackBoxwarningonESA.aspx.
Center for Medicare & Medicaid Services. (2007, March 14). Medicare reviewing erythropoiesis stimulating agents (ESAS) policies in response to FDAs recent black box warning and public health advisories (Press Release). Retrieved from http://www.cms.hhs.gov/apps/media/press_releases.asp.
Food & Drug Administration. (2007, March 19). FDA alert: Information for healthcare professionals Erythropoiesis stimulating agents (ESA) [Aranesp (darbepoetin), Epogen (epoetin alfa), and Procrit (epoetin alfa)]. Retrieved from http://www.fda.gov/cder/drug/InfoSheets/HCP/RHE2007HCP.htm.
Kaufman, J., et al. (1998, August 27). Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. New England Journal of Medicine, 339(9), 578-583.
McCarley, T. (2006). The KDOQI clinical practice guidelines and clinical practice recommendations for treating anemia in patients with chronic kidney disease: Implications for nurses. Nephrology Nursing Journal, 33(4), 423-428. Retrieved from http://www.nephrologynursing.net/supp/Supplement33423428.pdf.