Medicare's Coverage Determination for Epogen is Consistent with Labeling and Published Research

FDA: Medicare's National Coverage Determination on the Use of Epogen is Consistent with Approved Labeling and Published Research

WASHINGTON, D.C. – Representative Pete Stark (D-CA), Chairman of the Ways and Means Health Subcommittee, and Representative Henry Waxman (D-CA), Chairman of the Committee on Oversight and Government Reform, today released a letter from the Food and Drug Administration (FDA) on the use of erythropoiesis-stimulating agents (ESAs) in the treatment of anemia in cancer patients. In the United States, Amgen and Johnson & Johnson market ESAs as Epogen, Aranesp and Procrit.

In early October, Stark and Waxman requested FDA’s assessment of Medicare’s new National Coverage Determination (NCD) on the use of ESAs in cancer therapies. The letter makes clear that:

· FDA sees no quality of life benefit from the use of ESAs: “There is no evidence that ESAs result in improved survival, tumor control, health-related quality of life at any hemoglobin level in cancer patients undergoing chemotherapy.”

· Medicare’s new NCD is consistent with the FDA label: “FDA believes that the approved labeling and the CMS NCD are generally consistent in their recommendations regarding the use of ESAs in patients with cancer undergoing chemotherapy.”

· Medicare’s NCD is consistent with recent research: “FDA believes that the NCD is generally consistent with the available data and the published scientific literature.”

“Facts are stubborn things,” said Stark. “The FDA letter confirms what Amgen and Johnson & Johnson are spending millions of dollars to deny. Medicare’s new National Coverage Determination is consistent with the FDA’s recommendations and scientific research. Excessive use of ESAs increases the risk of tumor progression in cancer patients. Medicare’s action will prevent excessive use and protect patients’ lives.”

“Clearly the FDA letter confirms that the Medicare coverage decision is appropriately based on science,” said Waxman.

In March of 2007, the FDA issued a black box warning recommending the “use of the lowest dose necessary to avoid the need for blood transfusions” and cautioning against the administration of ESAs to raise patients’ hemoglobin levels above 12 grams per deciliter (g/dL). Transfusions typically happen at hemoglobin levels of 7 or 8 g/dL and rarely occur with patients whose hemoglobin is 10 g/dL or higher. Recent research has found that raising hemoglobin levels above 12 g/dL increases the risk of tumor progression, death and blood clots for certain cancer patients and increases the risk of death, blood clots, strokes, heart failures and heart attacks for End Stage Renal Disease patients.

Responsive to the published research and the FDA warning, the Centers for Medicare and Medicaid Services (CMS) recently issued a National Coverage Determination (NCD) on the use of ESAs in cancer patients. The final NCD allowed for ESA dosing of cancer patients up to 10 g/dL.

Stark and Waxman’s letter to the FDA is available at

The FDA’s response is available at