UPDATED: Boston Scientific faces reimbursement hurdles for lung-searing asthma treatment

Boston Scientific ($BSX) had high hopes for its electrode-tipped catheter treatment for asthma after snatching up the system in 2010 through its $193.5 million purchase of Asthmatx. But the company is hitting a wall with the product as insurers question the treatment's cost-effectiveness and safety.

As Bloomberg reports, Boston Scientific executives initially predicted the market for its Alair device would hit the billion-dollar mark by 2020. Even though the $20,000 procedure has backing from major medical groups, some of the biggest U.S. insurers, including Cigna and Anthem, are declining to cover the treatment because of its risks.

About a dozen small insurers decided to cover the treatment this year, the Bloomberg article notes. But Cigna, which recently completed a review of the device, says it needs more evidence before it gives its go-ahead. The product, which sears the walls of patients' airways to thin the muscle that cuts off air during an asthma attack, comes with a number of complications such as a severe asthma attack or bronchospasm. In a worst-case scenario, the treatment could lead to a punctured lung or bleeding.

"Bronchial thermoplasty is considered investigational and not medically necessary for the treatment of asthma," Jill Becher, an Anthem spokeswoman, told the news outlet. "This procedure has real and significant complications and the ongoing concern is the relative safety as compared to the benefit."

According to the Bloomberg story, the FDA received 62 reports of problems in patients who were treated with Alair during the past year, including two reports of death in individuals with preexisting health problems. And the device's benefits are not immediately apparent, leaving insurers wondering when the treatment will deliver on its $20,000 price tag. "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, as quoted by Bloomberg.

Still, Boston Scientific is standing by the procedure's safety, saying it has been clinically proven safe and effective out to at least 5 years, the company told FierceMedicalDevices in an email.

"Bronchial Thermoplasty has growing clinical support from prominent global societies and advocacy groups. Eleven health plans have a policy in place for the procedure, including the second largest Blue Cross Blue Shield plan in the U.S., and commercial payers have approved Bronchial Thermoplasty on a case-by-case basis, based on medical necessity," the company said.

And Boston Scientific is working hard to win insurer confidence with results from company-funded studies that point to long-term benefits with the device. The procedure reduces asthma attacks by 44% and cuts down on emergency room visits by 78% for 5 years--potentially salient findings as the company pushes for more widespread adoption of its product.

"The hurdles that are sometimes put in place of newer technologies are challenging and take a lot of time to clear," David Pierce, president of Boston Scientific's endoscopy division, told Bloomberg. "We have additional work to convince more and more payers to come on board."

- read the Bloomberg story

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Editor's Note: This story was updated with comments from Boston Scientific.