The U.S. Medicare health insurance program said on Friday it would reduce payments for anemia drugs when used to treat elderly and disabled patients who are undergoing kidney dialysis.
Anemia drugs known as erythropoiesis-stimulating agents, or ESAs, are sold by Amgen Inc. as Epogen and Aranesp and by Johnson & Johnson as Procrit.
"In response to safety concerns, we are modifying the ESA monitoring policy to provide greater restrictions on the dosage amounts of ESAs for which payment is made" for patients with hemoglobin levels above 13 grams per deciliter, the Centers for Medicare & Medicaid Services (CMS) said in a statement.
The new limits will take effect Jan. 1, 2008. CMS said it would take public comments to decide if it should further revise the policy.
Amgen said in a statement it was evaluating the new Medicare policy and its impact.
Johnson & Johnson spokeswoman Stephanie Fagan said the policy would not affect Procrit, because the company does not market the drug for use in dialysis patients.
Medicare spends about $2 billion annually on Epogen. Total sales for all the ESA drugs hit about $10 billion last year. Aranesp and Epogen account for roughly half of Amgen's profit.
Concerns about the risks of ESA drugs arose when a series of studies showed high doses could lead to heart complications or death, prompting the U.S. Food and Drug Administration to order stronger warnings. Makers say the medicines are safe and effective when used as directed.
Medicare's current policy requires cutting payment for the drugs by 25 percent if a dialysis facility reports a patient's hemoglobin level exceeded 13 grams per deciliter. The new policy will reduce payment by 50 percent if hemoglobin exceeds 13 for three consecutive months, CMS said.
Stanford Group analyst Gary Lieberman said the new policy was "relatively inconsequential" because "only a tiny fraction of patients would remain above 13 for three months."
In May, CMS proposed cutting payments for the ESA drugs when used to treat cancer.
The FDA, meanwhile, has scheduled an advisory panel meeting for Sept. 11 to review the risks and benefits of the drugs when used to treat kidney failure.
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