Less severe CMS limits for reimbursement of ESAs after 2,600 consultation responses

The US Centers for Medicare and Medicaid Services (CMS) has announced a less severe than expected national coverage determination for the use of erythropoiesis stimulating agents in cancer and related neoplastic conditions. The agency had decided to review its reimbursement policy after the Food and Drug Administration had issued a black-box warning regarding the use of ESAs (Marketletter March 19).

The CMS published a draft NCD on May 14 with a 30-day public consultation period, four months earlier than anticipated, according to analysts at Lehman Brothers (Marketletter May 21). The original proposals included a ruling that physicians would only be reimbursed by the CMS for ESA therapy for beneficiaries with cancer in circumstances where the treatment was not likely to worsen the condition and in cases where the beneficiary's anemia is responsive to the ESA.

Modified stance is good news for sales of Procrit, Aranesp and Epogen