Medicare officials may continue to pay for Amgen and Johnson & Johnson's big anemia drugs. But they may also change kidney-care guidelines that affect use of those treatments. As Reuters reports, the agency is proposing a removal of minimum hemoglobin targets for kidney patients, which could prompt dialysis providers to use less of Amgen's Epogen and J&J's Procrit.
Now, Medicare guidelines require that dialysis providers keep patients' hemoglobin levels above 10 mg per deciliter. That requirement often leads dialysis centers to use Epogen or Procrit to boost hemoglobin in their patients, who are prone to anemia. But the FDA recently changed the labels on those drugs to reflect new safety concerns, particularly about higher doses. The new labeling calls for the lowest doses possible to prevent transfusions.
The Centers for Medicare and Medicaid reassured people last week that the FDA's move wouldn't affect the government program's reimbursements for those drugs. But now, CMS says the proposed change to treatment guidelines would be "consistent with revised U.S. Food and Drug Administration guidelines." The new guidelines would require "the lowest dose...sufficient to reduce the need for red blood cell transfusions," the CMS statement says (as quoted by Reuters).
Amgen says that changing the guidelines could put kidney patients at risk of undertreatment. Medicare's treatment guidelines should "have a measure that protects patients from hemoglobin levels that fall too low," the company told Reuters.
- see the news from Reuters