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Evolving regulatory landscape with erythropoiesis-stimulating agents and impact on managed care.

Erythropoiesis-stimulating agents (ESAs) are a very effective treatment for reducing the need for transfusions in patients affected by anemia and either chronic kidney disease (CKD) or cancer. However, many clinicians remain wary of its use due to safety concerns. It has been shown that higher doses are associated with cardiovascular disease, stroke, or death. These concerns have spurred the US Food and Drug Administration to order Risk Evaluation and Mitigation Strategies (REMS) for clinicians prescribing ESAs to their patients. REMS are a method to ensure safety and provide clinicians and patients with an appropriate gauge of the risks and benefits associated with the administration of ESAs. Whether this restricts its use or lowers costs remains to be determined.