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Medicare may limit Amgen medicines

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Times Staff Writer

Medicare on Monday proposed limiting coverage of the anemia medicines that are the backbone of Amgen Inc.’s historically stellar growth, accounting for almost half of the Thousand Oaks company’s sales.

If Medicare follows through on its proposal, sales of the drugs, which have been slipping in recent months, would most certainly suffer. The Centers for Medicare and Medicaid Services’ acting administrator, Leslie Norwalk, estimated that federal reimbursements would fall by as much as 10%.

“The safety of our Medicare beneficiaries is paramount,” Norwalk said in an interview. “We are ensuring that members only get medications and dosages that are necessary and beneficial.”

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Medicare spends more on the anemia medications, which are taken by more than 1 million people every year, than on any other drug. The agency started its review after the Food and Drug Administration in March added a “black-box warning” to the drugs, advising doctors to prescribe them at their lowest possible doses and only to approved patients.

The announcement was made after the close of regular trading, where Amgen stock fell 23 cents to $56.07. The stock slumped to $54.10 in the after-hours market.

The shares are down nearly 18% since Jan. 1, when several studies, including a large Amgen-sponsored trial, found the anemia drugs might not be safe for some patients.

The drugs -- manufactured by Amgen and sold by that company under the brand names Aranesp and Epogen and by Johnson & Johnson as Procrit -- have been on the market for more than a decade. Combined sales topped $10 billion last year.

The FDA approved them to treat anemia caused by chemotherapy in an array of cancer patients and for people with kidney failure. But doctors have widely prescribed them for other people, including those not on chemotherapy, and in higher dosages than the FDA has endorsed.

In its proposal, Medicare said it would no longer pay for cancer patients’ use of the drugs if their anemia wasn’t related to chemotherapy or if the drugs were prescribed to prevent chemotherapy-related anemia.

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The agency will make a final decision in September.

An Amgen spokesman said the company was reviewing the Medicare proposal and would work with the agency. A Johnson & Johnson spokeswoman said that company was also evaluating the situation.

Starting last year, the drugs came under scrutiny after studies concluded that in some dosages the drugs might hasten death in some patients.

Thursday, an influential FDA advisory committee surprised the medical community and Wall Street by saying it might change the drugs’ labeling and asking for further study of their safety.

“We have a burning question,” one panel member, Dr. Silvana Martino, an oncologist in Santa Monica, said. “Do these things kill people?”

The FDA’s final labeling recommendation -- which might be to restrict dosages and what kind of patients should receive prescriptions -- is expected sometime this year.

Those restrictions could “eviscerate” the entire class of anemia drugs, Lazard analyst Joel Sendek wrote in a research note last week, and would “likely be devastating for Aranesp sales.”

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Also on Monday, the U.S. Supreme Court declined to consider a patent dispute between Amgen and two other companies involving Epogen.

Amgen initiated the dispute in 1997, suing Aventis Pharmaceuticals Inc., a unit of Paris-based Sanofi-Aventis, and Shire Human Genetic Therapies Inc. The two companies wanted to sell a competitor drug in the U.S. market and Amgen accused them of infringing its patents.

A federal court agreed with Amgen. Last year, the Court of Appeals for the Federal Circuit in Washington ruled in favor of Amgen on some patents but not on others.

With the split decision standing, analysts said it was still unlikely the competitor would make it to the U.S. market, although the court removed at least one legal barrier to that possibility.

daniel.costello@latimes.com

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