[Editors' note: As ONI went to press, FDA issued an alert announcing new boxed warnings and other safety-related product labeling changes for ESAs. The changes include a warning that the risks of shortened survival and tumor progression with use of ESAs in cancer patients have not been excluded when ESAs are dosed to reach a hemoglobin of < 12 g/dL and a recommendation that prescribers discuss these risks with their patients. Other new labeling emphasizes that in cancer patients, ESAs have not been shown in controlled trial to improve symptoms of anemia, quality of life, fatigue, or patient well-being.]

Hospital survey on transfusions

Matt Farber, manager of economic and public policy for the Association of Community Cancer Centers (ACCC), warned that taking a patient off an ESA in favor of transfusion may be more costly than continuing the medication.

ACCC surveyed 650 hospitals about this possible economic downside. Of the 125 hospitals responding, 41% said that an increase in blood transfusions of 30% would make it difficult to operate normally. An additional 16.5% said an increase of 10% or less would pose a problem, and 22% claimed any increase would strain resources.

Mr. Farber also said that anecdotal reports suggest that the new policy might indeed be causing a rise in blood transfusions in the hospital setting.

Oncology community responds

Many oncologists perceive the new NCD as yet another example of the government's intrusive presence in their day-to-day delivery of highly complex cancer care. As ASCO and other major cancer organizations exchanged formal letters with policymakers in Washington (see timeline chart on page 20), leading oncologists gathered on October 25 in Chicago to discuss concerns and develop a common response to the new NCD.

In their final statement, which was sent to officials on the Hill, they noted that more than 40 scientific studies support the evidence-based use of ESAs and stated that there is "no evidence of increased mortality or tumor progression when administered in accordance with the FDA label up to 12 g/dL."

In Washington, Dr. Bailes worked with policymakers to find common ground on the disagreement. He sent a letter to Steve E. Phurrough, MD, PhD, secretary of Health and Human Services, stating, "CMS misapplied clinical evidence or did not supply relevant, currently available scientific information when restricting coverage of ESA use in patients with hemoglobin above 10 g/dL." Dr. Bailes also noted that at the May 2007 ODAC meeting convened by FDA, the panel voted to maintain the FDA-approved label that sets the upper ESA limit at 12 g/dL.

In his letter, Dr. Bailes also expressed concern over the new CMS policy requiring ESA treatment to be discontinued if hemoglobin levels reach 10 g/dL or higher. Doctors would also be required to decrease dosing if the hemoglobin level rises more than 1 g/dL within a 2-week period, which would burden patients with weekly blood draws.