Intravenous iron as standard of care in oncology: Opportunity lost

Abstract

<h2>Abstract:</h2> In the past 4 months, the Centers for Medicare & Medicaid Services (CMS) has imposed restrictions on the use of eryth- ropoiesis-stimulating agents (ESAs) in oncology. ESAs can no longer be used to treat patients with hemoglobin (Hb) levels of more than 10 grams/dL or patients with cancer-related anemia who are not on chemotherapy. New recommendations to deny coverage of patients receiving curative (adjuvant) chemotherapy and patients with metastatic breast and head and neck cancer have been made by the Oncology Drug Advisory Committee (ODAC) to the Food and Drug Administration (FDA). ESAs are contraindicated in patients with untreated absolute iron deficiency. No International Statistical Classification of Diseases and Related Health Problems, 9th revision, code exists for iron-restricted erythropoi- esis (functional iron deficiency). This omission is particularly important, as aptly pointed out by Shord and Cuellar¹ in this issue of JAPhA, because five of five recent publications in the oncology literature (see article by Shord and Cuel- lar) have shown a markedly improved Hb response, decreased time to target Hb, decreased ESA exposure for equivalent benefit, and huge cost savings when intravenous (I.V.) iron was added to ESA therapy. These benefits, in all five papers, were independent of the baseline iron parameters, serum iron, total iron binding capacity, and serum ferritin. Adverse events with I.V. iron were negligible in all of the studies.