ASCO's second concern: CMS's new payment policy only allows a one-time dose escalation of 25% for hypo- or non-responderspatients with a rise in hemoglobin of less than 1 g/dL over 4 weeks of treatment. Dr. Bailes pointed out that the FDA-approved label for hypo- or non-responders allows for increases in weight-based dosing by 100%.
"Moreover," Dr. Bailes wrote, "the allowance for the 25% dose escalation applies only to the 5th week of ESA therapy within any one course of chemotherapy. The effects of myelosuppressive chemotherapy can be cumulative within any one course of chemotherapy, and this new restriction does not allow for dose escalation further into a course of chemotherapy."
The CMS decision also creates problems for responders. If patients respond to standard starting doses in the first 4 weeks, but their hemoglobin remains below 10 g/dL, they then enter the "maintenance" phase (from the 5th week through the end of that chemotherapy course, plus 8 weeks), Dr. Bailes wrote.
He protested that "after the 5th week, if a patient fails to respond as well to the standard dose, for example, due to the cumulative toxic effects of myelosuppressive chemotherapy, the clinician does not have the option of even the arbitrarily set 25% dose increase, and is allowed only to continue with the standard dose. This restriction interferes with the clinician's ability to titrate the dose as clinical judgment and the best interests of the patient dictate."
ASCO also expressed concern over provisions in the new CMS policy that require ESA treatment to be discontinued (if hemoglobin is 10 g/dL or higher) or the dose decreased (if hemoglobin is less than 10 g/dL) if hemoglobin rises by more than 1 g/dL within 2 weeks.
"We strongly disagree with CMS on the basic premise of disallowing ESAs above a hemoglobin of 10 g/dL," Dr. Bailes wrote. ASCO pointed out that patients will need weekly blood draws in order to determine the rate of hemoglobin rise over any 2-week period.
Dr. Bailes also wrote Louis B. Jacques, MD, director of CMS's Division of Items and Devices in the Coverage & Analysis Group. He pointed out that "under the new CMS policy, a patient's hemoglobin could repeatedly fall below 10 g/dL following termination of coverage at the end of
4-week periods. This consequence would be inconsistent with the FDA-approved labeling," which states that dosing should be titrated to maintain the individual's hemoglobin level.
Transfusion need will rise