ERBITUX

Implications: The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Global Research and Development at Amgen. "We are concerned that inappropriately limiting coverage for ESAs at hemoglobin levels less than 10 g/dL will both increase blood transfusions and severely compromise the high quality of cancer care delivered by American physicians. In our view, restricting coverage in this way is unreasonable, impractical and unworkable. Moreover, through this coverage decision, the CMS has undermined the ability of physicians to decide how best to administer ESA therapy to their patients through carefully defined dosing guidance articulated by the FDA."

Analysis: Medicare lae required to cover all treatment approved and indicated by FDA. This new ESA ruling violating this law. Amgen and orthobiotech may challange in court.