ESAs In Renal Use May Face New FDA, CMS Constraints; REMS Still In Progress
Executive Summary
Erythropoiesis-stimulating agents marketed by Amgen and Johnson & Johnson now confront possible restrictions on use in patients with anemia due to chronic kidney disease, as FDA and CMS gear up for separate advisory panel reviews of emerging safety data on such treatment
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FDA Advisory Committee Will Review ESAs In The Renal Setting Oct. 18
Meeting also could be next step in the process of determining whether safety issues are enough to drive changes to erythropoiesis-stimulating agent reimbursement at CMS.
ESAs In Renal Disease: Risk/Benefit Differs With Disease Stage, Amgen Says
Medicare coverage policy for erythropoiesis-stimulating agents in patients with chronic kidney disease should recognize that the ESA needs of patients are very different for those who are on dialysis versus those who are not, Amgen said in recent comments to the Centers for Medicare and Medicaid Services
ESAs In Renal Disease: Risk/Benefit Differs With Disease Stage, Amgen Says
Medicare coverage policy for erythropoiesis-stimulating agents in patients with chronic kidney disease should recognize that the ESA needs of patients are very different for those who are on dialysis versus those who are not, Amgen said in recent comments to the Centers for Medicare and Medicaid Services