Safety concerns over high doses of erythropoiesis-stimulating agents have led the US Centers for Medicare and Medicaid Services to limit payments of the anaemia drugs for patients undergoing kidney dialysis.
The proposal follows warnings from the US Food and Drug Administration’s oncology drugs committee that ESAs are overused and could shorten patients’ lives. In updated public health advice on May 14, the FDA warned that patients treated with the drugs have a higher risk of “serious and life-threatening side effects and a greater number of deaths" among several groups of patients including those in whom anaemia was caused by chemotherapy. The committee unanimously recommended new clinical trials for the drugs, including Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and Johnson & Johnson’s Procrit (epoetin alfa).
The new policy, which will come into effect on January 1, 2008, means the CMS will no longer reimburse ESAs to target haemoglobin levels greater than 13 grams per decilitre for the treatment of anaemia in patients undergoing kidney dialysis. It will, however, continue to reimburse ESAs administered to target haemoglobin levels between 10 and 12 grams per decilitre.
A spokesperson for Johnson & Johnson said the new policy “would not affect Procrit because the company does not market the drug for use in dialysis patients”.
The CMS decision follows agency restrictions in May on the use of ESAs for anaemia in patients with cancer, a final decision for which is expected next month. The FDA is also expected to hold an advisory meeting on the use of ESAs in the treatment of anaemia resulting from chronic renal failure on September 11.