FDA Repeats Agreement With CMS’ New Restrictive ESA Policy

November 9, 2007

During a conference call announcing new warnings and revised indications for erythropoiesis-stimulating agents (ESAs), the FDA repeated a statement that the Centers for Medicare & Medicaid Services’ (CMS) new restrictive reimbursement policy for the antianemia agents is consistent with approved physician labeling.

The CMS issued its final national coverage determination (NCD) for ESAs 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 NCD, the final determination includes limiting initiation of ESA therapy to when a patient’s hemoglobin levels are less than 10 g/dL.

“We say that they are consistent because in both cases the goal is to use the lowest dose to avoid the need for blood transfusion,” John Jenkins, director of the FDA’s Office of New Drugs, said in the Nov. 8 conference call. “The CMS coverage decision is based on the knowledge that blood transfusions rarely are provided to patients [who] have hemoglobin [levels] of 10 or greater.”

Amgen, manufacturer of ESAs Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), 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.

Sales of Aranesp declined 23 percent to $818 million during the third quarter of 2007 due to drug safety concerns and the NCD. Epogen sales declined 5 percent to $602 million during the third quarter because of decreased utilization driven by a pending ESA monitoring policy at the CMS for patients with end-stage renal disease and revised clinical guidelines.