2 Studies Could be Dose of Bad News for Amgen
In what could be a significant blow to Amgen Inc., the country’s largest biotechnology company, researchers reported in today’s New England Journal of Medicine that the dose of the company’s $1-billion-a-year anti-anemia drug Epogen could be reduced by about a third in kidney dialysis patients simply by injecting the drug under the skin rather than giving it intravenously.
And in a second round of bad news for the Thousand Oaks-based drug maker, another team of scientists reported that they stopped a study of Epogen after an unexpectedly high number of heart patients in the study died or suffered heart attacks.
Switching patients to injections could save the federal government--and cost the company--more than $200 million a year, according to Wall Street analysts, but physicians have been slow to make the change. Figures provided by the company show that more than 90% of hemodialysis patients taking Epogen--150,000 patients--receive their doses intravenously.
A company representative said that Amgen expected little impact on its sales from the two reports because in each case partial results had been reported earlier. And the federal agency that regulates the drug’s price has essentially left it up to physicians to decide how to administer it as well as how much to prescribe.
Patients and dialysis centers are reluctant to switch to the more painful method of injections, said Andrea Rothschild, a spokeswoman for Amgen. “The patients get their dialysis [intravenously] and it’s much more convenient to deliver Epogen that way. . . . Patients don’t want to be uncomfortable.”
However, kidney specialists said they hope that publication of the complete results of the two studies in the prestigious New England Journal would induce health practitioners to switch to the cheaper method of delivery. They point out that while most European dialysis patients routinely get the drug by injection, only about 10% of patients in the U.S. receive it in this more cost-effective way.
Convincing people to accept additional injections requires education, said Dr. Garabed Eknoyan, president of the National Kidney Foundation, and “when articles in the New England Journal of Medicine talk about convincing evidence, that goes a long way not only to convincing the physicians but the patients themselves.”
Analysts have a mixed view of the impact of the latest published findings, but agree it will take a few quarters for any effect to be seen.
“They will have little or no impact,” said Elise Wang, an analyst with Paine Webber Inc. She said that since a Kidney Foundation recommendation last October that also supported subcutaneous injections of Epogen, dialysis centers around the country have had an opportunity to switch their patients to the cheaper method. But a survey of centers showed that “none made the switch.”
Other analysts believe that the switch will be boosted by the New England Journal articles and an accompanying editorial, which urged doctors to follow the Kidney Foundation guidelines.
“Physician behavior is pretty calcified and tends to resist change in the short term,” said David K. Crossen of NationsBanc Montgomery. He said the New England Journal is likely to put pressure on the Health Care Financing Administration to deal with the cost issue. Sources within the Health Care Financing Administration, which sets Medicare payment policy, said that the new reports could give added impetus to changing federal policy. The government currently pays about $900 million a year for Epogen. Most people on dialysis are covered by Medicare, which pays 80% of the cost of the drug; patients or private insurers pay the rest.
But a report by the agency’s office of inspector general pointed out that existing reimbursement policy--which sets the price at $10 per 1,000 units of the drug--encourages overuse of the medication. A typical patient might require 10,000 units each week.
Amgen discounts the drug to dialysis clinics, which can buy it for about $9 per 1,000 units.
“The dialysis unit recognizes the more [Epogen] it gives, the more it gets reimbursed for,” said Dr. Peter DeOreo, a vice president of the nonprofit Centers for Dialysis Care in Cleveland.
Eknoyan and other experts said that the second study should serve as a caution to doctors who might consider administering increased doses of Epogen to heart patients.
Researchers in that study were baffled by the high number of deaths among heart patients chosen to receive enough Epogen to bring up their red blood cell counts to normal levels, said one of the authors, Dr. Anatole Besarab at the Henry Ford Hospital in Detroit.
If the study had been positive, it would have been welcome news for Amgen. Patients would have required doses three times the usual amount--more than offsetting any reductions caused by injecting the medicine.
Epogen is the only product available to boost red blood cell production in patients whose damaged kidneys no longer produce enough of the natural version of the substance.
Both studies reported today were underwritten by Amgen, the sole U.S. manufacturer of Epogen for kidney dialysis patients. Amgen shares fell 63 cents to close at $70 on Nasdaq.
