04 Jan 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Affymax and Takeda Pharmaceuticals, US, announced that the J-code assigned by the Centers for Medicare and Medicaid Services (CMS) for Omontys (peginesatide) injection is now effective. The permanent Omontys-specific billing code, J0890, will continue to provide for streamlined reimbursement for dialysis organizations prescribing the drug.
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 US.
"We believe that the J-code complements our efforts to make this once-monthly therapy broadly available to the dialysis community, and importantly, to appropriate patients. We are excited by the strong level of interest in the dialysis community for Omontys," said Mr John Orwin, chief executive officer, Affymax.
According to Mr Nicole Mowad-Nassar, vice president, marketing, 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 US 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, who are not on dialysis; who are 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.