On February 23, 2013, Affymax, Inc. and Takeda Pharmaceutical Company Limited, in conjunction with the U.S. Food and Drug Administration (FDA), initiated a voluntary recall of all lots of OMONTYS^® (peginesatide) Injection to the patient level due to reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. OMONTYS^® (peginesatide) is considered not medically necessary and, therefore, not eligible for reimbursement consideration as of February 23, 2013. For additional information on the recall of OMONTYS^® (peginesatide), read the news article, Voluntary Product Recall of the Drug OMONTYS^® (peginesatide) Injection Effective February 23, 2013, located on our Medical Policy portal.