Blue Cross will cover costly drug for asthma

By Liz Kowalczyk, Globe Staff, 10/9/2003

Blue Cross & Blue Shield of Massachusetts, the state's largest insurer, will pay for the first drug to prevent certain types of asthma attacks, but will tightly control which of its members get the unusually expensive medication.

US insurance companies are deciding how to handle coverage of Xolair, and are bracing for the cost. Federal regulators approved Xolair in June and Dr. Peter Goldbach of Blue Cross said it is the most expensive allergy and asthma drug the insurer now covers. The drug, which doctors give patients by injection once or twice a month, costs $10,000 to $12,000 for one year of treatment.

But Goldbach, a regional medical director, said Blue Cross decided this month to cover Xolair because it has the unique potential to prevent asthma attacks triggered by allergens such as dust, mold, or pollen, effectively shutting down the immune system's reaction to these triggers. "There's no other drug that does this," he said. Most other treatments control symptoms once they've begun.

Blue Cross, however, will maintain careful control over which of its 2.4 million members get Xolair, requiring doctors to ask the insurer's permission before prescribing it according to strict guidelines. Executives refused to comment on whether cost is a factor in Blue Cross's handling of the drug.

Harvard Pilgrim Health Care also decided to cover Xolair, but is developing guidelines under which it will pay for it. Tufts Health Plan is reviewing the drug and will make a ruling soon.

Physicians who specialize in allergies and asthma call Xolair a breakthrough for patients with moderate to severe asthma triggered by allergies whose symptoms are not well-controlled with inhaled steroids -- the only condition for which the Food and Drug Administration has approved it. But doctors routinely prescribe drugs for unapproved or "off-label" uses if they have reason to believe a medication will be helpful for patients; this probably won't happen with Xolair because of the cost.

Dr. John Saryan, an allergist at the Lahey Clinic in Burlington, said Xolair may help severe seasonal allergies or allergies to certain foods such as peanuts, which also involve a component of the immune system called IgE, which in the presence of allergens triggers the release of histamine that makes eyes water and noses run.

"Back in the late 1980s and early 1990s, we could try medications outside the recommendations, but this drug is so expensive we're not going to have that luxury," he said. "This is a new era now and these treatments coming out are going to have very strict guidelines. I understand why Blue Cross is doing this; they don't want to open the flood gates."

Dr. Aidan Long, clinical director of allergy medicine at Massachusetts General Hospital, said Xolair has not been proven effective for seasonal or food allergies, but that its manufacturer, Genentech, of San Francisco, is testing it for these conditions.

Asthma is a serious and sometimes life-threatening condition. Nearly 5,000 people die each year from asthma attacks, in which the lung airways become constricted and make breathing difficult. About 17 million Americans have asthma, and about 60 percent of these people have asthma that can be triggered by allergies, according to the American College of Allergy, Asthma, and Immunology.

Blue Cross estimates up to 4,000 of its members may qualify for the drug; that means Xolair alone could cost the insurer and its employers and members $40 million a year. Blue Cross's requirements for use of the drug mirror the FDA guidelines, including the stipulation that patients must have IgE levels within a specific range. But the insurer also will require that patients fail another treatment for at least three months. "There is a subset of patients who have persistent disease, rely on steroids, and still have symptoms," Goldbach said. "It should be reserved for these people."

Xolair is a genetically engineered protein that blocks the immune response of IgE. Genentech says the drug is expensive because of the steep cost of growing the antibodies in live cells, rather than chemically manufacturing the drug as is the case with most medications. In clinical trials of 1,000 teenagers and adults, patients reported 32 percent fewer asthma attacks on Xolair, compared with 21 percent fewer attacks on a placebo. But FDA officials said slightly more patients on Xolair developed cancer, and that the company is planning long-term studies to determine whether Xolair can cause cancer.

Several patients also had severe allergic reactions to the drug. Long said he requires patients to wait three hours in his office after a Xolair injection to make sure they don't have a negative reaction.

Still, doctors hope it will help some patients who still have dangerous asthma attacks despite taking other medications. Dr. Martin Ostro, a Mass. General physician, said he recently requested insurance approval for a woman who despite taking a high dose of inhaled steroids loses her breathe or wheezes climbing stairs, carrying groceries or rushing to catch the bus.

Liz Kowalczyk can be reached at kowalczyk@globe.com.