Several private payers have reported a sizable drop in ESA coverage. Lee N. Newcomer, MD, chief medical officer of United HealthCare, told ONI, "We anticipated this problem before it happened and initiated a pilot preauthorization program. We don't reimburse for patients with a hematocrit level that exceeds 36. Nor do we address starting levels, dosage maximums, or specific diagnoses in our policy. And we are seeing a 35% reduction in ESA usage with this edit alone."
In issuing a national coverage determination, CMS has the luxury of broadly interpreting the phrase "reasonable and necessary" in the context of forming coverage determinations. In making a noncoverage decision, such as in the use of ESAs, the agency determined that "the evidence is not adequate to conclude that the item improves net health outcomes for the patient."
The major oncology organizations have argued that used under proper guidelines, ESAs, in fact, are "reasonable and necessary" in relieving their patients' chemotherapy-induced symptoms.
Although the FDA's labeling for use of ESAs, for now, has somewhat conformed to the ASCO/ASH guidelines, the agency contends that its policy on the use of ESAs is essentially in line with those of CMS.
Despite their rhetoric of alliance, CMS and FDA are at odds with each other, looking at the same data but interpreting it differently. The two agencies actually agree only in two ways: ESAs should be avoided in cancer patients not receiving chemotherapy, and ESAs should not be used in patients with hemoglobin levels greater than 12 g/dL.In short, FDA's drug-safety and monitoring system has been slammed as inadequate and in need of reform by government agencies such as the Institute of Medicine and in the mainstream press. In what appears to be an effort to side-step the controversy, FDA's ESA warning label is essentially an ambiguous "swim at your own risk" sign that has baffled many oncologists around the country.
What happened to evidence-based medicine?
David H. Henry, MD, a clinical researcher at Pennsylvania Hospital who has led trials investigating ESAs, spoke to ONI about the issue.
"The current ESA issue is troubling," he said. "Despite a few explainable safety signals that came up in the 2004 ODAC [Oncology Drugs Advisory Committee] meeting, everything went well and the label was maintained. Then we came into the 'perfect storm' of the winter of 2007, and these purported safety signals pop up. It's hard to understand why there is so much retro-reaction, enough to almost eliminate the use of these drugs."