The Centers for Medicare & Medicaid Services on May 14th proposed limiting Medicare payments for use of biologic anemia drugs in treating certain cancers and related conditions.
The proposed national coverage decision (NCD) relating to use of anti-anemia biologics– Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit — was made in response to a Food and Drug Administration (FDA) black box warning regarding use of these drugs.
Medicare said it would only pay for use of the drug under specified conditions to treat anemia in certain cancers, and said it would not pay for the drugs to prevent anemia.
It also said patients needed to have certain hemoglobin levels before it would pay for the use of the drugs.
The Food and Drug Administration decision in March to add a “black box” warning to the drugs discusses a variety of safety concerns, and also recommends that the drugs be used at the lowest dose possible to boost red blood cell levels to the lowest level necessary to avoid blood transfusions.
“We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount,” said CMS Acting Administrator Leslie V. Norwalk, Esq. “We have carefully examined the evidence surrounding these labeling changes and have issued this proposed decision to protect our beneficiaries.”
Medicare’s proposal is open until June 13 for public comment, after which the government has another 60 days to complete its final decision. A final decision memo would be expected in mid-September.
