Some hospitals are starting to promote gastric band surgery for patients with lower BMIs, in a sign that the recent Food & Drug Administration decision to lower the threshold of obesity that a patient must exhibit in order to fit the indication for gastric banding surgery could turn out to be a boon for Allergan Inc. (NYSE:AGN).
The Davis Clinic in Houston, Texas, announced that it will offer the weight-loss surgery for the newly included range of obese patients, using Allergan’s Lap-Band device, which first won FDA clearance in 2001.
Prior to February of this year, gastric banding surgery was approved only for patients with a body mass index of 35 or higher. The FDA expanded the approved group to include patients with a BMI of 30 or higher who also exhibit a co-morbid condition like diabetes or hypertension, enabling about 26 million more people to opt for the surgery, according to a clinic release.
While the influx of candidates is a clear win for Allergan, the lower threshold of patients doesn’t qualify for insurance coverage, meaning they’ll have to pay cash for the procedure.
"We are hopeful that in the next few years, we will see that change," said Jamie Carr, clinical director at the David Clinic. "For the time being, the procedure must be done on a cash-pay basis, but of all procedures available today, the LAP-BAND is certainly the most affordable when an individual must pay for surgery themselves."
"Allergan is committed to continuing its efforts to ensure widespread coverage for those who qualify for the procedure," Cathy Taylor, Allergan spokeswoman, told MassDevice.
The device was originally indicated for use only in patients categorized as “severely obese,” with a BMI of 40 or 100 pounds or more over their estimated ideal weight. A BMI of 30 to 35 translates to about 35 to 65 pounds over estimated ideal weight.
The Centers for Disease Control & Prevention assign a BMI of 30 or above as "obese", while 25 to 29.9 is considered "overweight", and 18.5 to 24.9 is considered "normal".
In December 2010 the Gastroentology and Urology Devices Advisory Panel, which provides recommendations to the watchdog agency on product approvals, voted 8-2 that the FDA allow doctors to prescribe Allergan’s device for patients with a BMI of at least 35, or a BMI greater than or equal to 30 along with at least one co-morbid condition, such as diabetes or hypertension.
The February approval expanded the threshold of obesity to include patients right up to the BMI threshold for obesity. The FDA panel felt that the benefits of extending use of the device to healthier patients outweighed its risks.
The gastric banding system is permanently implanted around the upper portion of the stomach to reduce the amount of food than can be ingested. Gastric bands are considered less invasive and safer than stomach stapling or gastric bypass surgery, but some studies have shown that gastric bypass is more effective over the long run, especially for obese diabetics.
