LOS ANGELES (Reuters) - The Medicare federal health insurance program has confirmed plans to remove a requirement that kidney dialysis providers keep patient hemoglobin levels above a set minimum — a move likely to reduce use of Epogen, the anemia drug sold by Amgen Inc.
In a statement on its web site on Tuesday, the agency issued a final rule to remove, starting in payment year 2013, a requirement that patients’ hemoglobin, or red blood cell, levels be kept above 10 milligrams per deciliter.
It said the action was consistent with labeling approved by the FDA (Food and Drug Administration).
Medicare said dialysis providers should continue to target 12 g/dL has the top end for patient hemoglobin levels.
Analysts have surmised that the removal of a minimum hemoglobin target will result in minimal dosing of Epogen.
Officials at Amgen did not immediately respond to a request for comment.
The FDA earlier this year changed the labels for Amgen’s Epogen and Johnson & Johnson’s Procrit to call for lower dosing of the anemia drugs, which have been linked in recent years to safety concerns such as increased risk of heart problems.
Sales of the drugs have declined steeply in the past several years, but Epogen, along with Amgen’s second-generation drug Aranesp, and J&J’s Procrit are still expected to generate billions in 2011 sales.
The proposed change would apply under Medicare’s quality performance standards for “bundled” payments to dialysis providers and would affect payment years 2013 and 2014, the agency said.
While Medicare traditionally covers just elderly and disabled Americans, kidney disease patients are an exception. The program covers all those with end stage renal disease under a decades-old law.
Reporting by Deena Beasley