Reuters AlertNet Lite - Amgen challenges new Medicare anemia drug policy

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Amgen challenges new Medicare anemia drug policy

01 Aug 2007 01:46:43 GMT
Source: Reuters

LOS ANGELES, July 31 (Reuters) - Amgen Inc <AMGN.O> on Tuesday challenged a portion of a new coverage policy issued by the agency that runs Medicare, saying it will limit cancer patients' access to drugs that fight anemia.

Like some industry analysts, the world's biggest biotechnology company challenged the Centers for Medicare and Medicaid Services' (CMS) decision to deny payment for erythropoiesis-stimulating agents (ESAs) such as Amgen's Aranesp and Epogen or Johnson & Johnson's <JNJ.N> Procrit if a patient's hemoglobin level is greater than 10 grams per deciliter.

Amgen said it was concerned that "inappropriately" limiting coverage for ESAs at hemoglobin levels less than 10 grams per deciliter would increase the need for blood transfusions and compromise quality of care.

"In our view, restricting coverage in this way is unreasonable, impractical and unworkable," Dr. Roger Perlmutter, Amgen's executive vice president of global research and development, said in a statement.

The company added that limiting reimbursement only to patients with hemoglobin levels of less than 10 grams per deciliter is contrary to the U.S. Food and Drug Administration's approved labeling for ESAs.

Amgen, which last year had the best-selling biotech drugs with Aranesp and Epogen, also said the new CMS policy goes against the Oncologic Drugs Advisory Committee's recommendation against changing the upper hemoglobin limit of 12 grams per deciliter in the current FDA label and clinical practice guidelines from the American Society of Clinical Oncology and the American Society of Hematology.

The FDA in March put its strongest warning on the label of Aranesp and similar anemia drugs, calling on doctors to use the lowest dose that can effectively avert the need for blood transfusions due to concerns over safety and overuse.

ESAs are commonly used to battle anemia that results from chemotherapy or chronic kidney disease.

CMS earlier this month also proposed reducing payments for ESAs used to treat elderly and disabled patients who are undergoing kidney dialysis.

Shares of Amgen lost 4.4 percent, or $2.45, to close at $53.74 on Nasdaq a day after CMS released its coverage policy for cancer patients.

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Last updated:Wed Aug 1 01:47:18 2007