Erythropoiesis Stimulating Agents could be further restricted by Payers (Medicare, PBMs, and Healthplans)

Implications: Increased FDA warnings on ESAs, suchas Epogen, Procrit and Aranesp will provide payers the ability to further restrict these agents.   Restrictions will come in the form of prior authorizations and other utilization management techniques.

Analysis: The FDA is currently reviewing additional data from studies regarding the use of ESAs (such as Aranesp and Procrit) in breast cancer and advanced cervical cancers.  Studies have suggested that patients taking ESAs are show more rapid tumor growth than those who do not take ESAs.  If the FDA rules to restrict use in these indications it will provide payers the ability to restrict ESAs.  Medicare has already restricted their policy on reimbursement to specific indications and some private payers have followed suit.  Comments and direction from the FDA review of the additional data is much anticipated by payers.