California Insurer Shield Limits EPO Payments

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healthcoverage.jpgMore bad news for Amgen. Blue Shield of California, the nonprofit insurer with 3.3 million members, is limiting payments for anemia meds, which at high doses are linked to heart attacks and stroke. Docs are now required to wait until a patient’s anemia is just short of requiring a transfusion before using Amgen’s Aranesp and Epogen, or Johnson & Johnson’s Procrit.

But the new policy, which Bloomberg News reports was posted online on July 2, also says Procrit was the group’s preferred med.

The decision is the first of several attempts by health plans to lower expenditures for the drugs. In May, CMS, which paid $2 billion last year for Epogen alone, proposed similar limits that may begin next month. And Bloomberg notes that analysts say FDA safety warnings on the drugs’ heart risks could cut Amgen’s revenue by as much as $1.3 billion this year.

“We were astounded that Blue Shield of California has made such a policy decision,” Peter Eisenberg, a cancer doctor in California, wrote Bloomberg in an e-mail. The policy is “draconian” because more anemia patients will need blood transfusions.

Amgen spokeswoman Trish Hawkins says about 1,800 doctors, nurses and patient advocates have provided public comment since Medicare made a similar proposal in May. The “overwhelming majority” are opposed to limiting use of the drug below anemia levels in place before the San Francisco-based Blue Shield change, she says.

Anemia, a lack of oxygen-carrying red blood cells, causes weakness and fatigue. The drugs from Amgen and J&J are designed to boost concentrations of hemoglobin, a protein that carries oxygen in the bloodstream.

Blue Shield says it won’t pay for the drugs until hemoglobin levels fall to less than 9 grams a deciliter of blood for patients without heart disease, rather than 10 grams. David Seldin, a spokesman, wouldn’t say how much money the policy may save, saying it was based on “medical evidence only.”

Guidelines from the American Society of Clinical Oncology, or ASCO, based in Alexandria, Virginia, say patients should get an anemia drug when hemoglobin fall below 10 grams, Eisenberg notes.

The difference between 10 grams and 9 grams is significant, because the anemia drugs take time to work, Eisenberg says, and that means that the anemia drugs may not be able to prevent a patient from slipping to 8 grams a deciliter or lower, where a transfusion is generally required.

Blue Shield also says it won’t pay for the anemia drugs if patients are taking certain cancer medicines, including Genentech’s Avastin for colon and lung cancers, or ImClone Systems’ Erbitux for colon cancer. CMS is also considering that policy. ASCO, the largest U.S. group of cancer doctors, opposes it.

“There is no basis in law or medical evidence to support such restrictions, and ASCO strongly opposes them,” Joe Bailes, chair of the cancer group’s government relations council, wrote in a June 8 letter to the Medicare agency. Bailes added that the action creates “the perception that restrictions are proposed for the sole purpose of limiting expenditures.”

Blue Shield of California’s decision follows a recommendation from the national Blue Cross Blue Shield Association’s medical advisory panel, and from the Medicare Services agency, Blue Shield’s Seldin said in a telephone interview.

Last month, Democratic Representative Pete Stark of California, chairman of the House Ways and Means Health subcommittee, said at a hearing that Medicare’s payments encourage overuse of the anemia drugs, wasting taxpayer money and endangering lives.

An FDA advisory panel of cancer experts voted 15-2 on May 10 that the FDA should place new restrictions on the drugs. The committee didn’t specify any change to the recommended doses.

Amgen’s Hawkins said in a statement that her company wants reimbursement decisions to be based on “a comprehensive review of the evidence so that appropriate patients can continue to access these important medicines.”

Blue Shield didn’t say why it switched to Procrit as the preferred anemia drug, ahead of Epogen; chemically, the drugs arethe same. “We support Blue Shield of California’s goal of ensuring that its coverage policies encourage appropriate use,” of anemia drugs, says Stephanie Fagan, a spokeswoman for J&J’s Ortho Biotech, which markets Procrit.

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