This is why the Food and Drug Administration and the American Gastroenterological Association plan to hold a public workshop Dec. 19 and 20 to discuss the regulation and reimbursement of minimally invasive procedures and medical devices that treat morbid obesity and other metabolic diseases.
An estimated 80 million adults and 15 million children in the U.S. are obese. Of the drugs that have come to market to reduce weight in patients, several have been withdrawn and newer drugs lead to modest weight loss.
About 200,000 people in the U.S. undergo bariatric surgery each year, a number that makes up less than 1% of the nation's total adult obese population.
There are only two devices currently on the market that treat obesity—the Lap-Band Gastric Banding System, which Allergan recently sold to Apollo Endosurgery, and the Realize Gastric Band, which is marketed by Johnson & Johnson's Ethicon Endo-Surgery business unit. (Gastric bypass and sleeve gastrectomy procedures do not implant devices.)
Utilization of the bands is declining, and the sleeve gastrectomy procedure has started to replace them, said Dr. Lee Kaplan, director of Massachusetts General Hospital's Weight Center in Boston. While the bands were used in nearly half of bariatric surgeries three years ago, they are now being used in about 10% of these surgeries, and that change in utilization has been attributed to how invasive the procedures are and a better understanding about their effectiveness, he added.
The FDA has already recognized some of the challenges in bringing obesity devices to market. Agency officials late last year proposed a benefit-risk assessment that they say would provide a more consistent pathway to approval.
The assessment would take into account the different benefits and risks of these types of devices in development, noting that devices aiming for greater weight loss would carry a different risk profile than those aiming for lower amounts of weight loss, according to an article published in Surgical Endoscopy in December 2012.
“We are moving away from our 'one-size-fits-all' approach to clinical trial outcomes for these devices,” FDA officials wrote. “This paradigm aims to help industry assess the anticipated risk of their devices and to size their study better so that the data will be sufficient for a regulatory decision.”
Physicians say payers must also begin to change the way they evaluate obesity devices for coverage. For example, a health plan might cover a procedure that leads to a 60% weight loss for a patient but not one—if such a procedure were available—that provides a 20% to 30% weight loss, even though it's a less invasive procedure that has fewer side effects, is potentially reversible and can be done in one day.
These factors “have not traditionally been taken into account” by insurers, Pasricha said. “A lot of patients want that choice.”
Follow Jaimy Lee on Twitter: @MHjlee
