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Originally published Monday, September 15, 2008 at 12:00 AM

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Regence cutting use of Botox to treat patients' migraines

Regence BlueShield will discontinue coverage for Botox treatments for migraine attacks starting Oct. 1. The insurer says emerging scientific evidence shows that the wrinkle-relaxing toxins work not much better than placebo injections.

Seattle Times health reporter

Toni Arcuri has tried just about every treatment during her 30-year battle against crippling migraines: acupuncture, yoga, biofeedback, antidepressants and even drugs to control seizures.

Then seven years ago, the Seattle paralegal found lasting relief — with Botox, the wrinkle relaxer.

That's not as improbable as it may seem. Anecdotal reports first surfaced in 2000 that cosmetic patients who'd had Botox injections to smooth facial lines discovered that they subdued headaches as well.

Since then, several clinical studies have suggested that the muscleparalyzing effects of Botox may help reduce the frequency and severity of migraines.

But Arcuri's insurer, Regence BlueShield, now has concluded that Botox's supposed powers are not backed by evidence.

Citing what it called mounting studies showing that Botox is not much more effective than placebo injections, Regence will stop paying for Botox treatments for migraines beginning Oct. 1. Arcuri and others already on Botox can keep their coverage only if they can show that nothing else works and that Botox helps measurably.

As many as 3.6 million Americans suffer from chronic headaches or migraines, but only a small fraction of them ever try Botox.

Regence is apparently the first major health insurer in Washington to discontinue altogether its Botox coverage for new headache sufferers. Several other insurance plans, including Premera Blue Cross and the state employees' Uniform Medical Plan, permit Botox as a last-resort option.

More promise than proof

Regence's move is the latest example of insurers applying clinical evidence to set coverage guidelines. Group Health Cooperative, for instance, never authorized coverage for Vioxx — the arthritis drug recalled in 2004 because it raised the chances of heart attacks and strokes — after the co-op's pharmacists flagged the possible safety risks.

By Regence's own admission, it granted coverage for Botox based more on promise than on proof. Sean Karbowicz, Regence's manager of pharmacy services, said it did so because patients with intractable headaches have few good treatment options.

But Karbowicz said at least three well-designed studies published since 2004 have concluded that Botox is not significantly better at preventing migraines than a placebo.

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Karbowicz allows that Botox may provide real relief for a small number of patients. But he argues that isn't enough to warrant coverage.

"There is not reliable evidence that Botox works," he said. "It just doesn't make sense to continue to cover this."

Regence made a similar decision several years ago when it stopped paying for the stimulant Provigil for multiple-sclerosis patients. Provigil initially was thought to alleviate fatigue associated with multiple sclerosis, but well-designed studies failed to bear that out.

Some headache specialists criticized Regence for a decision they saw as dictated more by money than by medicine.

Regence is "totally screening the patients out of treatments that actually may help them," said Dr. Sylvia Lucas, director of the headache clinic at the University of Washington Medical Center.

Expensive treatment

Botox is the brand name for botulinum toxin A, which is derived from the same bacteria that causes food poisoning. Exactly how the toxin works on headaches is unknown, though one theory is that it may desensitize nerves that detect pain.

The treatment is expensive, about $650 every three months or so for the drug alone.

Botox was initially approved by the federal Food and Drug Administration in 1989 for blepharospasm, or spasm of the eyelids, and for strabismus, also called cross-eyes. In 1992, an ophthalmologist presented the first public paper noting that Botox caused her patients' frown lines to disappear.

That chance discovery seemed to repeat itself when dermatologists began hearing from patients that Botox seemed to banish their migraines, too. But that hope has not stood up to scientific scrutiny, said Dr. Ann Pakalnis, a director of the Headache Clinic at Nationwide Children's Hospital in Columbus, Ohio.

"There is no definitive information in the research literature that suggests [Botox] unequivocally mitigates severity of headaches," Pakalnis said.

Pakalnis said a few patients might benefit from Botox, but there is no way to identify them before treatment.

Dr. Sheena Aurora, director of the Swedish Headache Center and Arcuri's physician, said Regence acted prematurely.

Aurora is the lead author on one of a pair of studies to be released next year that she said will provide the first definitive evidence that Botox can help prevent chronic migraines.

On Thursday, Allergan, Botox's manufacturer, which paid for the studies, said preliminary results were encouraging enough that it plans to petition the FDA to approve Botox for chronic migraines.

Pakalnis said Allergan has sponsored many such studies, a fact she said "is always something to be mindful of when results are interpreted."

Karbowicz said Regence will reconsider its policy if the latest studies prove that Botox makes meaningful clinical difference.

Aurora fears that in the meantime, some patients will lose their only remedy against debilitating pain. The FDA has approved several drugs to prevent or treat migraine attacks, including Imitrex and Depakote. But they can cause side effects and don't always work.

"Botox is for people who have tried everything else," Aurora said. The fact that not everyone benefits "doesn't mean it doesn't make a difference in somebody's life."

"Worst pain ever"

Arcuri knows that firsthand.

The 43-year-old described her migraines as simply "the worst pain ever," sometimes leaving her incoherent, unable to speak or even to think.

Prescription drugs helped, but caused side effects. Depakote, an anticonvulsant, for instance, left her foggy and drowsy.

When she had Botox coverage, Arcuri received shots every four months or so. Aurora would inject the toxin around her temples, the back of the head, the neck and upper shoulders. The shots dampened the pain so Arcuri could be "high functioning."

But Arcuri lost her coverage for nine months while she fought to get Regence to continue her treatments. Then last month, after a volley of calls, faxes and letters, Arcuri won approval for four more sessions.

Arcuri said it upsets her that she has to battle for a remedy that — scientifically proven or not — for her clearly works.

Regence "took it as a blanket invitation to deny all coverage," she said. "It has wasted so much time and money."

Kyung Song: 206-464-2423 or ksong@seattletimes.com

Copyright © 2008 The Seattle Times Company

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