Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) today announced that the J-code assigned by the Centers for Medicare and Medicaid Services (CMS) for OMONTYS ® (peginesatide) Injection is now effective. This permanent OMONTYS-specific billing code, J0890, will continue to provide for streamlined reimbursement for dialysis organizations prescribing OMONTYS. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the adult dialysis patient population with chronic kidney disease (CKD) in the United States (U.S.).
“We are excited by the strong level of interest in the dialysis community for OMONTYS,” said John Orwin, chief executive officer, Affymax. “We believe the J-code complements our efforts to make this once-monthly therapy broadly available to the dialysis community, and importantly, to appropriate patients.”
According to Nicole Mowad-Nassar, vice president, marketing at Takeda, “We are pleased to have an effective J-code in place approximately nine months following the approval of OMONTYS.”
OMONTYS was approved by the U.S. Food and Drug Administration (FDA) on March 27, 2012, for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is not indicated and is not recommended for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life. Please see Important Safety Information including Boxed WARNINGS below.Information on OMONTYS Reimbursement Support Customers seeking additional information about accessing the product can refer to the OMONTYS Reimbursement Access Support (RAS) program. RAS offers comprehensive reimbursement access, and support services for healthcare providers. For more information please call 1-855-GOMONTYS (1-855-466-6689) for more information. About OMONTYS ® (peginesatide) Injection OMONTYS is a synthetic, pegylated ESA. It is the only ESA that is peptide-based and its building blocks (amino acids) are arranged in a different order than erythropoietin (i.e., it has no sequence homology to endogenous erythropoietin).