FDA broadened the indication on Allergan's Lap-Band to include obese adults with a body mass index (BMI) of 30 to 40 and at least one obesity-related comorbid condition, such as diabetes, heart disease or gallstones. The expanded indication, announced yesterday, brings an estimated 37 million Americans into eligibility for the gastric band, according to a company statement.
“Similar to the current indication for Lap-Band and our supporting promotional activities, we will continue to raise awareness of the proper benefit/risk profile of the device for patients who may be candidates based on their BMI qualifications,” said Caroline Van Hove, and Allergan spokesperson, in an email. She declined to discuss specific marketing plans for the new indication.
The Lap-Band implant requires surgery and can be expensive, making insurance coverage a key element in product sales. Hove said the Lap-Band is “currently covered by most insurance plans in the US for patients who are morbidly obese,” but coverage for patients eligible through the new indication “may take up to two years,” she said.
In an earnings call on February 2, David Pyott, chairman and CEO at Allergan, said new sales resulting from the expanded approval would take time. “It will be very useful for us in our conversations with managed care, not only to get coverage of greater than 30 BMI with one comorbidity, but especially to get better conditions for greater than 35 BMI,” he said. Allergan's Lap-Band had sales of $243 million in 2010, according to an Orange County Business Journal report. The device leads the gastric band category, commanding 73% of the market in the fourth quarter of 2010, according to Pyott.
Covidien co-promotes the Lap-Band with Allergan in the US.