ESA label: Less, but less so
The new FDA-approved label for erythropoiesis-stimulating agents reinforces the defacto two-tier structure for treating chemotherapy-associated anemia that emerged in July when Medicare determined it would cover narrower use of ESAs than that permitted on the original label.
In its revised label released last week, FDA has given physicians discretion to administer an ESA in all patients with hemoglobin (Hb) levels up to 12 g/dL. Although it isn't breaking with clinician consensus on use of ESA's in their core renal setting, the label is in sharp contrast to CMS, which restricts usage in chemotherapy-associated anemia to individuals with a Hb level of 10 or lower.
Despite FDA's assertions that the label is "consistent" with CMS's National Coverage Decision (NCD), it places Medicare as an outlier among regulators and payers that have weighed in on the critical issue of the Hb ceiling for chemotherapy patients.
The new FDA labeling is similar to