Oncologists Protest Government Interference in Medical Decisions

Fifty of the country's leading oncologists met in Chicago to discuss the new National Coverage Decision (NCD) regarding the use of Erythropoiesis Stimulating Agents (ESAs) in cancer treatments for Medicare patients. ESAs are synthetically produced drugs of a naturally occurring protein called erythropoietin. Erythropoietin is manufactured by the kidney. ESAs allow patients to cope better with chemotherapy by boosting red blood cell counts.

In July, 2007, the Centers for Medicare and Medicaid Services (CMS) limited the use of ESAs when hemoglobin levels were less than 10g/dL, limiting treatment duration to a maximum of 8 weeks, limiting the starting dose, and limiting dose escalation levels. These limitations were imposed due to the Food and Drug Administration's (FDA) warning regarding the use of ESAs. The FDA found that ESAs increased the risk of stroke, blood clots, heart attacks, tumor growth, and death. This FDA finding led to revised product warnings, a new box warning, and a modification to dosage instructions.

When speaking of the NCD regarding ESAs, the Centers for Medicare and Medicaid Acting Deputy Administrator Herb Kuhn said, "Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries." However, oncologists and patients across the country do not see it this way. They are concerned that the NCD creates a two-tiered system of care where doctors are forced to choose between standard of care and what Medicare's coverage will reimburse.

The American Society of Clinical Oncology and the American Society of Hematology have released a joint guideline on the use of ESAs which suggests hemoglobin can be raised to a concentration of 12. Under the current NCD, Medicare patients under the hemoglobin level of 10 would be subjected to blood transfusions which expose patients to added health risks.

At the Chicago meeting a final statement, which is being sent to Washington policymakers, included the following, "The NCD, by limiting our ability to use supportive care drugs ... hinders oncologists' ability to provide life saving or life prolonging treatments and will impose different, less effective cancer treatment regimens." The 50 oncologists, chaired by Dr. Peter Ellis, Medical Director of the University of Pittsburgh's Medical Center Cancer Centers, urged the CMS to reconsider the NCD and acknowledge the clinical standard of care with respect to ESAs.

The drugs (Aranesp, Epogen, and Procrit ) affected by the FDA decision and the NCD are all produced by Amgen Inc. Amgen has recently announced efforts to improve its cost structure by restructuring worldwide operations and to cutting approximately 12 to 14% of its work force. These measures are due to the recent regulatory and reimbursement changes which has affected the sales of ESAs.

Sources:
"Amgen's Third Quarter 2007 Adjusted Earning Per Share Increased 4 Percent to $1.08", Amgen.
"Medicare posts Final National Coverage Determination for the Use of Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions",Centers for Medicare and Medicaid Services.
"FDA Strengthens Safety Information for erythropoiesis-Stimulating Agents (ESAs) ", U.S. Food and Drug Administration.
U.S. Oncology, "Leading Oncologists from Across the Country Hold Emergency Meeting on New Governmental Reimbursement Policy for Medicare Patients with Cancer", PR News Wire.
"ASCO and ASH Release Updated Guideline on the Use of Chemotherapy-Related Anemia Treatments in Cancer Patients", American Society of Clinical Oncology.