Los Angeles Times Examines Rising Costs of Anemia Drug Epogen
The Los Angeles Times on Tuesday examined CMS' concerns over dialysis treatment Epogen's rate of prescription and "skyrocket[ing]" cost to Medicare, which more than doubled between 1998 and 2002 to $1.2 billion. Epogen, produced by California-based Amgen, is a "true wonder drug" that has reduced the need for blood transfusions for anemia patients by boosting red blood cell counts and has accounted for more than $17 billion in sales since it arrived on the market in 1989, the Times reports. The four largest dialysis chains, from which most kidney patients receive Epogen treatments, made a 12% profit in 2003 from Epogen sales to Medicare beneficiaries, according to a report released last week by HHS investigators. Sales of Epogen, which accounted for 30% of Amgen's $8.4 billion in revenue for 2003, "are under pressure" from a requirement in last year's Medicare law that requires CMS to "bring its Epogen payments in line with the drug's cost," which is about $62 per dose, the Times reports. In part because the provision in the Medicare law could induce dialysis chains to use less Epogen, Amgen's earning growth could decline to an estimated 18% in 2005 from 37% in 2003, according to Thomson First Call.
To help reverse the expected drop in sales, Amgen and dialysis centers have asked CMS to change the standard for blood cell counts, or hematocrits, that are used to determine whether a patient needs Epogen. CMS currently supports keeping hematocrits in dialysis patients between 33 and 36. Dialysis industry representatives have asked CMS to raise its upper limit to at least 39, and Amgen officials have said that it is more beneficial to patients to begin Epogen treatment before hematocrits reach 30. Although increased Epogen use raises blood cell counts, there is some debate over what levels are beneficial and what levels are damaging. An FDA study released last week said that hematocrits above 36 "may contribute to an increased risk of cardiovascular ... events" in dialysis patients. In addition, William Owens, an adjunct professor at Duke University, conducted a study last year that found that raising CMS' hematocrits standard to 42 would add $1.4 billion to Medicare costs. According to Raymond Hakim, chief medical officer of Nashville-based Renal Care Group and chair of a lobbying group whose members include Amgen, "Ideally, you would want no upper limit. Even if you use more Epogen, it is better for patients. And what is better for patients is better for Medicare" (Gellene, Los Angeles Times, 5/11).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.