LOS ANGELES (Reuters) - The U.S. Centers for Medicare and Medicaid Services (CMS) said on Wednesday it is reviewing its coverage of anemia drugs used to treat patients with kidney disease.
The drugs, Epogen and Aranesp made by Amgen Inc and Procit made by Johnson & Johnson, have come under increased scrutiny after data from trials showed they could raise the risk of heart problems.
The move was expected after the agency convened a panel of experts earlier this year who concluded that the drugs, erythropoiesis-stimulating agents, could harm patients with chronic kidney disease, RBC Capital Markets analyst Michael Yee said.
RBC has already projected a 25 percent decline in sales of Amgen’s Epogen from 2011 to 2013, due mostly to a plan by CMS to “bundle” payments for dialysis patients.
Aranesp is mainly used to treat anemia in cancer patients, with some $300 million of annual sales coming from kidney patients who are not on dialysis, Yee said. J&J’s Procrit is also used in the cancer setting.
Regulators have set restrictions already on the use of anemia drugs for cancer patients, which has led to sales declines, but the drugs remain blockbusters. Amgen had 2009 sales of $2.7 million for Aranesp and $2.6 billion for Epogen.
Yee said Aranesp sales would be reduced primarily if CMS were to lower the target level for red blood cells, or hemoglobin, in the pre-dialysis setting.
Amgen said in an email that it believes that evidence supports a hemoglobin range of 10-12 grams per deciliter for all kidney disease patients as outlined in the drugs’ current FDA-approved labeling.
The company said it would submit additional comments and documents by the July 16 deadline CMS has set.
RBC’s Yee said it is possible that the agency may not do anything drastic until more guidance or feedback from the Food and Drug Administration, which may convene an advisory panel meeting later in the year.
The drugs are one of the biggest prescription costs for Medicare, which pays for the healthcare of about 45 million elderly and disabled as well as the cost of treating around 90 percent of all U.S. citizens with end-stage renal disease.