Medicare kidney dialysis guidelines finalizedThu Apr 3, 6:58 PM ET
The U.S. Centers for Medicaid & Medicaid Services said on Thursday that it has finalized coverage guidelines for patients undergoing kidney dialysis that do not include changes in anemia treatment.
The agency last year set restrictions on the use of anemia drugs for cancer patients that led to sharp declines in sales for drugmakers Amgen Inc and Johnson & Johnson.
The revised dialysis regulations mainly address issues of patient rights, patient safety and the patient's participation in the care process. The agency said in a statement that the regulation also gives dialysis centers more flexibility in the use of resources.
"We believe that with this CMS ruling Amgen avoided another potentially negative event, and we are leaving our Epogen estimates unchanged at this time," UBS analyst Maged Shenouda said in a research note on Thursday. The analyst forecast Epogen sales of $2.4 billion in 2008, growing to $2.6 billion in 2011.
Amgen's Epogen is used to treat anemia in patients undergoing kidney dialysis, while the company's Aranesp is used in patients with kidney disease and cancer patients undergoing chemotherapy. Under a license from Amgen, J&J sells Procrit for treating cancer patients. The drugs are genetically engineered versions of a protein that boosts production of oxygen-carrying red blood cells.
The Medicare agency last year sharply restricted reimbursement for anemia drugs used to treat certain cancer patients, citing studies which cast doubt on the drugs' safety.
Advisors to the U.S. Food and Drug Administration last month recommended that use of the drugs be tightened, but said the medicines should remain on the market for most cancer patients.
The drugs are one of the biggest prescription costs for Medicare, the U.S. insurance plan for about 43 million elderly and disabled. Worldwide sales of Amgen's Aranesp fell 12 percent to $3.6 billion in 2007 compared with 2006, while sales of Procrit fell 9.4 percent to $2.9 billion over the same period.
http://news.yahoo.com/s/nm/20080403/hl_nm/amgen_medicare_dc_2
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