Amgen Inc.'s Aranesp anemia drug was removed for use in some cancer patients from a list that Medicare and insurers follow for reimbursement, threatening as much as $500 million in sales, according to one analyst.
Aranesp is approved to treat anemia in cancer patients undergoing chemotherapy and in kidney-disease patients. The U.S. Pharmacopeia, an independent reference list that sets standards for use of drugs, removed Aranesp as a treatment for cancer patients not on chemotherapy whose disease had caused anemia, JPMorgan Securities analyst Geoffrey Meacham said Thursday in an investment note.
The removal "puts $400 million to $500 million of Aranesp sales" at risk, Meacham said.
David Polk, a spokesman for Thousand Oaks-based Amgen, said the removal did "not mandate a coverage change unless there is a policy change."
"Medicare coverage is status quo right now," he said.
Recent studies have raised concern that Aranesp may be harmful when used to treat anemia in certain cancer patients for which the drug isn't approved. The medicine is Amgen's biggest-selling product, generating $4.12 billion last year for the biotechnology company.
The Cancer Letter last Friday published results from a Danish study of head and neck cancer patients undergoing radiation that showed more participants given Aranesp experienced a recurrence of tumors than those not given the drug. The study was halted in December.