Sept. 5, 2012— -- For Jenny McLeland, 33, of St. Louis, severe asthma restricted not only her breathing but her daily life.
McLeland, who has had asthma since birth, tried everything her doctors recommended to relieve her asthma, from playing sports to taking the highest dosage of asthma medication.
"It felt like someone's strangling you," said McLeland. "It's scary when you have nowhere else to go and what you're on is the best you're going to get."
In 2007, McLeland enrolled in a clinical trial for an invasive procedure called bronchial thermoplasty. Since then, she hasn't experienced a single asthma attack.
For hundreds of severe asthmatics who have undergone bronchial thermoplasty – the first nondrug treatment for asthma approved by the U.S. Food and Drug Administration in 2010 – the results have been life-changing.
"When you've lived with it for so long, you learn to adapt to it, but it's been amazing realizing after the thermoplasty how much I was limited," she said.
However, the dramatic improvement comes with a hefty price tag.
Bronchial thermoplasty is expensive, costing anywhere from $15,000 to $20,000 depending on the procedure, and most insurance companies won't pay for it.
The treatment is reserved only for patients for whom medication hasn't worked. Although five-year follow-up studies have found the procedure to be safe and effective, most insurance companies still consider the procedure experimental.
McLeland is one of many who have bypassed the cost of the treatment by enrolling in a clinical trial. Her husband was also successfully treated through the same trial. This treatment is not something she could afford if it wasn't for a clinical trial, she said.
But not all patients who qualify for the procedure necessarily qualify for a study. Nearly 25 million Americans have asthma. As much as 10 percent of people with asthma have what is considered the most severe form and make up the majority of the health care costs of the disease.
Americans spend nearly $18 billion on asthma, the majority of which is spent on treating the illness through emergency hospital visits and multiple medications, according to the Asthma and Allergy Foundation.
"Knowing that we have another way to attack asthma and have another tool in our toolbox is extremely exciting," said Dr. Sumita Khatri, co-director of the Asthma Center for the Cleveland Clinic.
Bronchial thermoplasty works by delivering thermal energy to the airway wall through a catheter to burn away smooth muscle that is inflamed in asthma patients.
The procedure, completed in three sessions, widens the airways enough to decrease the ability of the airways to constrict in response to a trigger and reduce the frequency of asthma attacks.
The procedure is currently available in more than 150 medical centers in 40 states. Studies suggest that the average patient who undergoes bronchial thermoplasty is likely to experience a 30 percent reduction in asthma symptoms and an 82 percent reduction in asthma-related visits to the emergency room.
"This is a one-time treatment and it's very effective and safe," said Dr. Lisa Kopas, a pulmonologist at St. Luke's Episcopal Hospital in Houston.
But the procedure isn't expected to rid patients of medications completely.
While bronchial thermoplasty is FDA-approved to reduce asthma symptoms, it has not been shown to improve lung function or reduce over-response in the airways that triggers the need for rescue medications.
"Your asthma will not be cured," said Khatri, who said that research is still under way regarding the procedure. "All of these [procedures] are nice and good, and hopefully we'll find more benefits in the longer term, but you'll still need to be on your asthma medications."
Dr. Michael Simoff, director of bronchoscopy and interventional pulmonology at Henry Ford Hospital in Michigan, has had 30 to 40 patients referred to him over the past six months for the procedure. He's had to turn many patients away because insurance will not pay for the treatment and the patients can't afford it.
"It puts us in a difficult situation," said Simoff. "My hands are tied, because we see people, we evaluate them and see that they're good candidates, but they don't fill the criteria to be in a study."
Simoff has petitioned many insurance companies in Michigan to review their policy, but it's been slow-going, he said.
In January 2012, the Centers for Medicare and Medicaid Services agreed to pay for the disposable catheters used during bronchial thermoplasty. The procedure requires three bronchoscopies using three catheters that cost around $1,000 to $2,500 each.
"I do think it will become a mainstream procedure in the long run," said Simoff. "I really believe that when we move forward, the patients will need less medication." Many who believe in bronchial thermoplasty, including Simoff, said insurance coverage would not only benefit the patient but would save insurance companies money in long run.
"I'm saving so much money not having to pay for monthly medications that were mostly covered by health insurance," said McLeland. "The overall cost coverage for insurance companies of that and the emergency room visits makes it beneficial."
"Asthma care is one of the most common and costly chronic conditions for insurers," said Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America. "This new procedure for severe asthma is an important breakthrough for patients, especially for a disease like asthma, where there has not been much change in the therapy options for a decade.
Even with the current out of pocket costs, many patients find the relief from their asthma worth it.
"Day to day life is affected when you can't breathe well," said Khatri. "Whenever a patient is able to afford it, if they believe in it strongly enough, they're willing to pay."