AMGEN: Could Take Hit From NEJM Studies
Kidney dialysis patients taking the anti-anemia drug Epogen could use a third less of the drug if it was injected under their skin instead of administered intravenously, according to a study in today's New England Journal of Medicine. Researchers affiliated with Department of Veterans Affairs facilities nationwide studied 208 patients receiving care at 24 hemodialysis units and found that the "average weekly dose" of Epogen "during the maintenance phase was 32% less" for the patients who had switched to subcutaneous injections (Kaurman et al, 8/27 issue). The Los Angeles Times reports that the study "could be a significant blow to Amgen Inc.," the pharmaceutical giant that manufactures Epogen. Amgen's annual Epogen sales total $1 billion, with $900 million coming from Medicare, which covers most kidney dialysis patients. Wall Street analysts said converting patients to injections "could save the federal government -- and cost the company -- more than $200 million a year." Almost all (90%) of Epogen users currently take it intravenously.
Amgen spokesperson Andrea Rothschild said the company expected the study to have "little impact" on Epogen sales because "partial results had been reported earlier," and Medicare would most likely let physicians decide how to administer the drug to patients. In addition, Rothschild noted that "[p]atients don't want to be uncomfortable" and that taking Epogen intravenously is much more "convenient" because patients are already getting their dialysis intravenously. Elise Wang, an analyst with Paine Webber Inc., agreed that the study would "have little or no impact." But Dr. Garabed Eknoyan, president of the National Kidney Foundation, said "when articles in the New England Journal of Medicine talk about convincing evidence, that goes a long way not only to convince the physicians but the patients themselves." Health Care Financing Administration sources said the report "could give added impetus to changing federal policy" regarding Epogen. Currently, Medicare pays $10 per 1,000 units of Epogen, while Amgen sells it to the dialysis centers for $9 per 1,000 units. "The dialysis unit recognizes that the more (Epogen) it gives, the more it gets reimbursed for," said Dr. Peter DeOreo, vice president of Centers for Dialysis Care in Cleveland. Analyst David Crossen of Nationsbanc Montgomery said, "If [HCFA] ignores the opportunity to lower costs, it could be accused of mishandling the ball" (Jacobs, 8/27).
An accompanying editorial in the NEJM notes that while switching to subcutaneous application of Epogen did lower the amount needed by about 30%, more than one-firth of the patients (23%) who switched actually needed more of the drug. "Thus, although the findings appear to be sound, management will need to be individualized to ensure that the most effective dose and route of administration are chosen," writes Dr. John Adamson of the New York Blood Center and Dr. Joseph Eschbach of Seattle's Minor and James Medical (8/27 issue). The Times notes that another study published in today's NEJM also could be "bad news" for Amgen. The study, which looked at the use of Epogen by dialysis patients with cardiac disease, had to be stopped "after an unexpectedly high number" of the participants "died or suffered heart attacks." Both NEJM studies were underwritten by Amgen (8/27). Click injection or click cardiac disease to view abstracts of the two Epogen studies.