"The consequence of this premise would be inconsistent with the FDA-approved labeling, which states that dosing should be titrated to maintain the patient's hemoglobin level," Dr. Bailes said.

Updated ASCO/ASH guideline

On October 22, ASCO and ASH jointly released an updated guideline on the use of ESAs in chemotherapy-related anemia (see Table). According to ASH, the guideline update was developed by examining two meta-analyses that reviewed close to 60 randomized clinical trials.

"Our goal is for these evidence-based recommendations to influence practice standards and result in better care," Samuel Silver, MD, PhD, ASH executive committee councillor, said in an interview with ONI. "Our guidelines are the product of several years of collaborative work, not a reaction to the recent CMS decision."

FDA acknowledges its ESA labeling has caused confusion among oncologists about dosing recommendations. Dr. Silver said part of the confusion stems from FDA's reply to Rep. Peter Stark's request for clarification of the labeling recommendations. In the reply, FDA said it "believes that the approved labeling and the CMS national coverage decision are generally consistent in their recommendations regarding the use of ESAs in patients with cancer undergoing chemotherapy."

Said Dr. Silver, "The term 'generally consistent' is a carefully chosen and rather peculiar bit of legalese, because although the NCD is encompassed within the FDA labeling, there are some patients who, because of the restrictions of dosing above 10 g/dL, are actually excluded by the NCD."

ASH and ASCO propose keeping the hemoglobin concentrations between 10 and 12 g/dL following the first administration of an ESA, but under the new NCD, oncologists would have to wait until a patient's level drops below 10 g/dL and would not be allowed to use the drug until the hemoglobin once again falls below that level, he said.

A dual coverage system?

"It's my understanding that private payers are generally following the ASH/ASCO guidelines, which effectively creates a dual coverage system, one for Medicare beneficiaries and one for the remainder of the private payer community," Dr. Silver said.

Unfortunately, he added, "legislation is not the optimal way of handling this issue. We feel that the national coverage decision should have been an open analytical process, decided by examining the extensive scientific data in the literature that we used to establish the recently issued ASH/ASCO guidelines."

Safety vs profit?