August 26, 2007
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857
Dear Ms. Phan:
On behalf of the American Nephrology Nurses Association (ANNA), I am writing to express our appreciation to you for allowing us to submit comments to the FDA Cardiovascular and Renal Drugs Advisory Committee joint meeting with Drug Safety and Risk Management on September 11-12, 2007 regarding erythropoiesis-stimulating agents (ESAs). As an organization dedicated to providing the highest quality care for patients suffering from kidney disease, we are pleased that the FDA is holding public hearings on the use of ESAs, which are used for the treatment of anemia in Chronic Kidney Disease (CKD).
ANNA is a professional nursing organization of more than 12,000 registered nurses practicing in nephrology. ANNA members are intimately involved in the supervision and delivery of care to adults and children with kidney disease. Our members work in a variety of settings including dialysis facilities, transplant centers, CKD clinics, acute care, ambulatory clinics and long-term care. ANNAs purpose is to advance nephrology nurse practice and positively influence outcomes for patients with kidney disease through advocacy, scholarship and excellence.
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 changed 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. We care very much about regulations and decisions affecting the quality of care of the patient population we serve and will continue to communicate new developments to our members.
Again, thank you for the opportunity to participate in the review of the use of ESAs in the treatment of anemia of CKD. If you have any questions, or if we can be of assistance to you or your staff on kidney disease, nursing or related matters, please do not hesitate to contact me.
Sandy Bodin, MA, RN, CNN
American Nephrology Nurses Association