ESAs require caution under stricter FDA guidelines; reimbursement subject to change

The new year has begun, but controversy over erythropoiesis-stimulating agents for chemotherapy-induced anemia continues. Restrictive FDA revisions to ESA labeling have had a profound effect on the management of patients with anemia as well as on the practice of oncology itself.

Many in the oncology community feel that the decision by FDA to update the black-box warning and make other changes in the labeling for ESAs, including a compulsory patient medication guide for every new patient receiving these agents, is yet another example of government’s overarching intrusion into the clinical decision-making process.

Latest revision

According to the most recent FDA revisions to ESA labels, the only oncologic (nonrenal) use for ESAs is in cancer patients receiving myelosuppressive chemotherapy who meet the following criteria:
• For initiation of ESA use, the anticipated treatment outcome is not cure, and the hemoglobin level is less than 10 g/dL.
• For continuation of ESA use, the anticipated treatment outcome is not cure, and the patient has not yet attained a hemoglobin level sufficient to avoid red blood cell transfusion.

It is important to note that Medicare and many private payers will not cover costs associated with administering ESAs to a cancer patient receiving myelosuppressive chemotherapy with hemoglobin levels greater than 10 g/dL.

At present, CMS does not make a distinction in its coverage policy between patients in curative and noncurative settings-that is, Medicare covers ESAs administered to patients regardless of anticipated outcome, cure, or palliation, as long as they meet CMS’s other requirements. It is possible that CMS may soon reconsider their coverage policies based on the new approved indications for ESA use by FDA.

Provider beware Because coverage determinations at the local level cannot be more restrictive than CMS coverage, local carriers should continue to reimburse for costs associated with ESAs administered in the curative setting. However, oncologists are urged to monitor this situation and to check with their local carriers for specific guidance.

Insurance coverage

In the upcoming months, private insurers may institute revisions to their coverage policies based on the new FDA-approved restrictions on ESA use.

In order to avoid any messy billing problems, physicians should always check with individual health plans regarding any changes in reimbursement policy.

For more information on ESAs, see article “Continued regulatory actions affecting the use of erythropoiesisstimulating agents” by Karen Hagerty, MD, in the Journal of Oncology Practice (4:267-270, 2008).