CMS moves quickly on ESA coverage limits

The US Centers for Medicare and Medicaid Services (CMS) has announced its proposed decision to limit coverage of erythropoiesis stimulating agent treatment for beneficiaries with certain cancers and related neoplastic conditions. The decision was taken "because of a deleterious effect of the ESA on the beneficiaries' underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use, the federal agency annoncement, in a statement.

According to analysts at Lehman Brothers, the CMS announcement came "four months earlier than expected," (see page 18). Among the products affected are biotechnology major Amgen's Aranesp (darbepoetin alfa) and health care giant Johnson & Johnson's Procrit (epoetin alfa), both firms are USA-based. ESAs are anti-anemia biologics, synthetic versions of erythropoietin, a hormone that is produced in the kidney.

The proposed national coverage decision was made in response to a Food and Drug Administration black box warning regarding the use of ESAs (Marketletter March 19). The warnings have been added to all ESA labels. The CMS explained that the FDA's action had prompted it to open a National Coverage Analysis, on March 14, concerning the use of ESAs for conditions other than end-stage renal disease. The FDA subsequently conducted an Oncologic Drug Advisory Committee meeting in early May, raising concerns about the use of ESAs for oncology patients.