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According to Dr. Patrick Cobb, a practicing oncologist from Billings, Montana, and Chairman of the COA Clinical Practices Committee, "What prompted this recent request to CMS to reconsider its decision to restrict ESA use was the release on November 8, 2007 of revised FDA-approved labeling for ESAs." Dr. Cobb added, "Unfortunately, what FDA considers safe and effective ESA use, CMS does not. As a result, our Medicare patients are not receiving the same standard of care as our younger patients."
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The ESA labeling revisions include additional warnings related to risks associated with the use of ESAs "when dosed to target a hemoglobin of >= 12 g/dL" and instructs physicians to "use the lowest dose needed to avoid red blood cell transfusions" in order to minimize risk. However, the FDA specifically notes in both the revised label and its accompanying press release dated November 8, 2007 that, "no clinical data is available" to establish the risk of using ESAs when hemoglobin levels are less than 12 g/dL. The CMS NCD, on the other hand, arbitrarily prohibits ESA use when hemoglobin levels are 10 g/dL or higher.
"We use ESAs to reduce the need to give our patients transfusions, so we don't expose them to undue risks," said Dr. Cobb. "ESAs are important drugs, as are all the therapies we use to treat our patients--patient safety is always our primary concern. However, what CMS has done is to actually limit our ability to use ESAs in a way that minimizes transfusions."
In its reconsideration letter to CMS, COA notes, "It is readily apparent the CMS NCD essentially overrules the FDA scientific expertise by deeming ESAs unsafe and ineffective when used in the range of >=10 g/dL and <12 g/dL. Equally distressing is the fact that CMS is using a reimbursement policy to substitute its own clinical judgment, rather than allowing physicians to exercise their own clinical judgment for each individual patient's circumstances, as recommended in the newly revised FDA-approved label." COA further notes, "there is evidence to suggest that initiating ESA treatment at a hemoglobin level >10 g/dL significantly reduces the risk of transfusion."
COA is asking CMS for immediate reconsideration of the portions of the NCD dealing with cancer patients undergoing chemotherapy.
For additional information contact Ted Okon, COA Executive Director, [email protected], 203-715-0300.
The Community Oncology Alliance (COA) is a non-profit organization. The mission of COA is to foster and protect the community oncology delivery system in the United States through public policy, advocacy, and education. Eighty-four percent of Americans battling cancer receive high quality, affordable, and accessible cancer care in community oncology clinics close to home. The accessibility of high quality cancer care, coupled with earlier diagnosis and new therapies, has resulted in a decreased cancer mortality rate.
SOURCE Community Oncology Alliance
