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ESAs: Request Dropped for Review of Medicare Decision


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http://money.cnn.com/news/newsfeeds/art ... RTUNE5.htm


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NEW YORK -(Dow Jones)- Amgen Inc. (AMGN) has decided to drop its request that the Centers for Medicare and Medicaid Services reconsider last year's decision that restricted payments for use of the company's anemia treatments in cancer patients.

The decision comes a week after the Food and Drug Administration ordered changes to the labels of the drugs, known as erythropoiesis-stimulating agents, or ESAs, sold by Amgen and Johnson & Johnson (JNJ), that restricted their usage in the same patients. Those changes didn't incorporate all the recommendations of a March FDA advisory committee and were seen as less restrictive than the CMS centers' guidelines that significantly cut into sales.

"The revised FDA label permits physician discretion to manage individual patients with ESAs to maintain hemoglobin levels necessary to avoid blood transfusions," said Amgen spokeswoman Kelley Davenport.

"We look forward to discussing the final ESA label with CMS," she said.

The drugs treat anemia by boosting the number of red blood cells and are currently approved to treat patients with kidney disease and cancer patients receiving chemotherapy.

Amgen sells the drugs under the brand names Aranesp and Epogen, but Epogen is marketed only for kidney-failure patients on dialysis, because Amgen licensed other uses of the drug to Johnson & Johnson, which sells it as Procrit.

Last summer, CMS issued a so-called national coverage decision that denied payment for the drugs when they are used in patients with hemoglobin levels exceeding 10 grams per deciliter through duration of treatment.

The new label for the drugs states that they aren't to be administered when hemoglobin levels are at or above 10 grams per deciliter, but calls for treatment to stop if the hemoglobin exceeds a level needed to avoid transfusion - which allows for discretion.

Amgen had formally filed for reconsideration of that decision, as did Johnson & Johnson, the American Society of Clinical Oncology, the American Society of Hematology and patient groups.

Officials from Johnson & Johnson weren't immediately available for comment.

"We view Amgen's decision as wise," wrote Deutsche Bank analyst Mark Schoenebaum in a note to clients early Friday, noting that the company's aggressive campaign to change the decision was unsuccessful.

Schoenebaum said he believes that the reconsideration process strained Amgen's interactions with both CMS and the FDA.

Those relationships are important because Medicare pays for the majority of existing Epogen sales and the Amgen will soon be seeking FDA approval of potential blockbuster bone drug denosumab, he notes.

Denosumab is vital for Amgen after sales of its formerly high-growth anemia franchise dropped 11% in 2007, following studies that showed the drugs may be overused, increase cardiovascular risks and fuel certain kinds of cancer. Total revenue fell by 3.5% in the year and the company's market value was cut nearly in half over an 18-month period.

The March panel met after studies tied the products to shortened survival times and faster tumor growth, as well as a risk of blood clots, under certain circumstances. The drugs already carry strong safety warnings on their labels.

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(CNNMoney.com, By Thomas Gryta, Dow Jones Newswires, August 8, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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