Blue Shield of Ca. curbs anti-anemia drug limits

By Lisa Baertlein

LOS ANGELES (Reuters) - Blue Shield of California said on Wednesday it reversed parts of a recent policy change that limited when the insurer would pay for anemia drugs sold by Amgen Inc and Johnson & Johnson following protests from doctors.

Privately held Blue Shield, which has more than 3 million members in California, earlier this month imposed new coverage guidelines that, among other things, required doctors to wait until an anemic cancer patient's hemoglobin level fell to levels closer to the cutoff for needing a blood transfusion.

The drugs at issue include Amgen's Aranesp and Epogen, and J&J's Procrit, which belong to a class known as erythropoietin-stimulating agents (ESAs) that are used to boost levels of oxygen-carrying red blood cells.

Aranesp and Epogen, Amgen's biggest revenue drivers, were the top-selling biotech drugs in 2006 with sales of roughly $7.2 billion, according to IMS Health. Procrit was 2006's fifth-biggest biotech drug with sales of $2.9 billion.

ESAs have been under intense scrutiny over concerns about their safety and potential overuse.

Blue Shield spokesman David Seldin said that as of its July 20 update, the insurer would cover anemia drugs when a patient's hemoglobin levels hit 10 grams per deciliter of blood or less.

On July 2, its guidelines had required hemoglobin levels to fall to 9 grams per deciliter of blood or less, except in the case of patients with heart conditions whose coverage would kick in when hemoglobin levels hit 10 gm/dl or less.

Blue Shield had previously covered the drug for patients with hemoglobin levels of 11 or less.

The company did not reverse its revision that halted reimbursements to cancer patients with anemia who are not on chemotherapy, he said.

Chemotherapy-induced anemia is the primary use for Aranesp, by far Amgen's biggest drug. But a study earlier this year showed increased risk of death in cancer patients taking Aranesp who were not undergoing chemotherapy, leading to curtailed use for anemia of cancer.

Blue Shield also stuck by its previous decision that requires physicians to use J&J's Procrit first for patients who have not initiated therapy. Patients who are already taking Aranesp will not be required to change, Seldin said.

The U.S. Food and Drug Administration in March ordered drug makers to place a "black box" warning, the strongest possible, on ESAs to encourage doctors to use the lowest effective dose needed to avoid blood transfusions amid concerns they could increase the risk of heart attack and stroke.

The moves by Blue Shield follows a proposal from the Centers for Medicare & Medicaid Services in May that would limit payments for the drugs.

Cancer doctors, facing restrictions for use of the drugs in patients not receiving chemotherapy, have railed against the changes in public and in private, calling the changes draconian and cautioning that they set a dangerous precedent in which government regulators tell doctors how to practice medicine.

"We are pleased Blue Shield has revised its ESA policy, insuring that appropriate cancer patients can continue to access these important medicines," Amgen said in a statement.