(Bloomberg) — Two years ago, Christi Thompson’s doctor put her under anesthesia, slipped an electrode-tipped catheter into her lungs, and used its hot end to sear the walls of her airways, thinning the enlarged muscle that cuts off a patient’s air during an asthma attack.
Before, her asthma could get so bad she couldn’t speak, and she regularly ended up in the emergency room. Since the procedure, Thompson, 43, hasn’t been once.
Yet a medical breakthrough for Thompson has been a financial disappointment for Boston Scientific Corp. While the $20,000 procedure has backing from major medical groups, its sales are so small the company doesn’t report them. Boston Scientific executives initially projected it would be a billion-dollar market by 2020. The company paid $193.5 million in 2010 to acquire the technology, now called Alair, with the purchase of Asthmatx Inc.
One problem is getting reimbursed for the procedure, approved in the U.S. five years ago. Many of the country’s biggest insurers, including Cigna Corp. and Anthem Inc., say they’re concerned about Alair’s risks of complications and have declined to cover the therapy. There’s also the availability of inexpensive asthma drugs, and the potential for the disease to lessen or clear up on its own.
Pressure is building on insurers after the American College of Allergy, Asthma and Immunology gave its support for the procedure, bronchial thermoplasty, earlier this month, joining six other health organizations. About 26 million Americans have asthma.
“The hurdles that are sometimes put in place of newer technologies are challenging and take a lot of time to clear,” said David Pierce, president of Boston Scientific’s endoscopy division. “We have additional work to convince more and more payers to come on board.”
A dozen insurers have begun covering the method. The largest is Health Care Service Corp. Cigna completed a review of the procedure Wednesday, saying the therapy needs more research even though its results are promising. Others will probably also wait for a long-term study of the technology.
“Bronchial thermoplasty is considered investigational and not medically necessary for the treatment of asthma,” said Jill Becher, an Anthem spokeswoman. “This procedure has real and significant complications and the ongoing concern is the relative safety as compared to the benefit.”
The most common complications are congestion that can feel like a severe asthma attack, bronchospasm and worsening of airway hyper-reactivity. The most feared is a punctured lung or bleeding. The procedure, which builds on a similar approach used to treat erratic heart rates, is done three times on different parts of the lung.
The FDA received 62 reports of problems arising in patients treated in the past year, often trouble breathing that required hospitalization during recovery. Two patients with pre-existing health problems subsequently died, though it’s not clear what role the treatment played.
Thompson, who is a home economics teacher from Pike County, Ohio, spent two days recovering in the hospital when she had breathing problems shortly after the procedure. Yet she now suffers severe symptoms far less often, and uses her asthma drugs less frequently as well. “I don’t have to use my nebulizer as many times a day as I did prior to the surgery, and I don’t feel I’ve had to take as many bouts of steroids,” said Thompson.
A typical patient can go home the same day as the procedure and often is able to return to work the next day, said Erhan Dincer, a pulmonologist who does the procedure at the University of Minnesota Medical Center.
Dincer only considers the most severe asthma sufferers for the treatment, once all other options have failed. Insurance companies still deny about 60 percent of his patients, though once a company covers the first patient and sees the response, it’s much easier for those following, he said.
Boston Scientific is relying on doctors to advocate for the procedure. Part of the issue is that it can take time for the benefits to show up, leaving insurers skeptical of when a $20,000 outlay will pay itself back.
“It takes a year if not a couple of years to see how much of an impact it has. You aren’t going to see it in three months,” said Jonathan Bernstein, director of clinical research at the University of Cincinnati and editor-in-chief of the Journal of Asthma. Bernstein treats Thompson and referred her for the procedure.
Company-funded studies show that bronchial thermoplasty cuts asthma attacks by 44 percent and slashes emergency room visits by 78 percent for five years.
Yet Boston Scientific, whose shares are up 35 percent this year, is trying to get traction at a time of increasing pressure on expensive drugs and procedures. “The cost is finally reaching a tipping point where it just can’t go much further,” said Edward Black, president of Reimbursement Strategies LLC, which advises life sciences companies. “It’s as if the health plans are realizing employers are really serious when they say they can’t afford it anymore.”
—With assistance from Zachary Tracer in New York.