Statement By US Oncology On FDA Label On Erythropoiesis Stimulating Agents (ESAs)

Main Category: Cancer / Oncology
Also Included In: Blood / Hematology;  Regulatory Affairs / Drug Approvals
Article Date: 10 Nov 2007 - 0:00 PDT

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US Oncology, which supports one of the nation's largest cancer treatment and research networks representing over 1,100 oncologists nationwide, supports the FDA's label outlining the safe and effective administration of ESAs at the minimum level of the range 10-12 grams per deciliter (gm/dL), a declaration that has long been a central part of the US Oncology physician network's recommended clinical guidelines.

Recently, a number of health concerns have arisen for ESA dosing levels exceeding 12 gm/dL. The FDA's new label repeatedly notes the upper safety limit is 12 gm/dL, and preserves physician discretion to use the lowest dose possible in order to avoid blood transfusions - widely regarded as cumbersome for patients and carry several health risks -- and to continue treatment within the range of 10-12 gm/dL.

Physician discretion remains the critical point of debate. The current FDA labeling provides flexibility for patients and physicians to decide whether the use of ESAs is appropriate for each individual case. These considerations may include the type and anticipated duration of chemotherapy and its known impact on blood cell reproduction.

The new FDA label supports anemia management protocols adopted by US Oncology, the American Society of Hematology (ASH), the American Society of Clinical Oncology (ASCO), the European Agency for the Evaluation of Medicinal Products (EMEA), and all major U.S. health insurance plans. All of these groups support the same physician-centric approach and reflect a target range of 10 gm/dL and 12 gm/dL. This treatment range stands in contrast only to the National Coverage Determination (NCD) recently adopted by the Centers for Medicare and Medicaid Services (CMS), which denies coverage for ESAs above the hemoglobin levels of 10 gm/dL.

US Oncology and its affiliated network of physicians continue to be concerned that the NCD interferences with medically-evidenced treatment protocols for cancer patients and creates a two-tiered health care system based on insurance -- one for patients with Medicare and one for patients with private insurance. Under the new CMS NCD policy, Medicare beneficiaries risk reaching hemoglobin levels oncologists regard as inappropriately low for health and safety, and as a result, will risk blood transfusion.

One new warning in the FDA label states, "the risks of shortened survival and tumor promotion have not been excluded when ESAs are dosed to target a hemoglobin of < 12 gm/dL." While US Oncology agrees with the accuracy of this statement, numerous clinical trials looking at adverse events in the 10-12 gm/dL range have found no evidence of increased mortality or tumor progression.

Given this new label, US Oncology maintains that patients should continue to review the risks and benefits of the most safe and effective anemia management protocol with their physician while undergoing chemotherapy to treat their individual disease.

US Oncology
US Oncology