Aranesp, Epogen and Procrit Policy Justified, Medicare Official Says.Feb 11, 2008 | Parker Waichman LLP
More trouble for Aranesp, Epogen and Procrit. Senior Medicare official Dr. Barry Straube said evidence—including two studies—is mounting in the case for cutting the use of controversial anemia drugs sold by Amgen Inc. and Johnson & Johnson. Medicare cut payments for the use of those drugs in cancer patients last year and the U.S. Centers for Medicare and Medicaid Services (CMS) is reviewing its decision following criticism from cancer doctors and drug makers.
Studies continue to question the drugs' safety and back the policy Straube, chief medical officer at CMS, enacted. "I think that our national coverage decision has been shown, with even more evidence coming out since we made it, to have been the right thing to do," Straube said. The drugs are erythropoietin-stimulating agents, also known as ESAs, and include Amgen's Aranesp and Johnson & Johnson's Procrit. Both medications are multi-billion-dollar selling drugs. CMS issued payment restrictions in 2007 after four large studies raised safety concerns and the Food and Drug Administration (FDA) required a stronger warning on the drugs' labels. The drugs can boost risk of heart problems and even death, especially at high doses.
Labels for Aranesp, Epogen, and Procit were updated to include revised dosage guidelines and information on the drugs’ cardiovascular side effects. The modifications followed the FDA ordering of a black box warning—the strongest drug labeling—about cardiovascular problems and other safety issues. Amgen manufactures all three medications although Johnson & Johnson sells Procrit under a licensing agreement. The drugs are part of a class of drugs known as ESAs that treat anemia in patients with kidney disease or certain cancers by boosting red blood cells. Several studies linked the drugs to cardiovascular problems and deaths and have been tied to worsening tumors when used in cancer patients. Soon after Epogen was introduced, some doctors attempted to use it to increase patients’ hemoglobin—the part of the blood cell that carries oxygen—to levels as high as those in healthy patients (14). Two clinical trials showed the large dosage required to reach these levels could lead to heart problems and death and the black box warning cautioned doctors that the medications should be administered at the lowest dose possible to bring blood counts to the lowest level needed to avoid transfusions. The modified black box warning has more specific dosing information stating dosing should be individualized. For kidney patients, the revised warning reads that patients experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower hemoglobin levels in two clinical studies’ rather than the more generic warning that risks were seen when hemoglobin levels of greater than 12 were targeted. Following the revised warning, Medicare announced it would not pay for Aranesp, Epogen, and Procrit in patients whose hemoglobin levels were at 10 grams per deciliter.
Straube said he believes the FDA will consider restricting use of the drug in some cancer patients. The entire drug class has been under review as debates continue over whether anemia drugs increase the risk of heart attack and stroke and fuel the growth of cancer.