FDA reiterates that CMS rule on antianemia drugs is consistent with labeling

WASHINGTON The Food and Drug Administration has again said that the Centers for Medicare and Medicaid Services new restrictive reimbursement policy for antianemia agents is consistent with approved physician labeling.

The CMS issued its final national coverage determination for erythropoieses-stimulating agents earlier this year after the FDA approved new warnings for use of the products in patients with cancer and chronic kidney failure. Although not as restrictive as the proposed national coverage determination, the final determination includes limiting initiation of erythropoieses-stimulating agents therapy to when a patient’s hemoglobin levels are less than 10 g/dL.

Amgen, manufacturer of erythropoieses-stimulating agents Aranesp and Epogen, said it plans to request that the CMS revise its coverage determination to allow physicians to be reimbursed for administering the biologics to patients when their hemoglobin levels are between 10–12 g/dL.