Explore this issue:September 2015
Now the injection, developed by Kythera Biopharmaceuticals (Westlake Village, Calif.) and marketed as Kybella, has been approved by the FDA for the treatment of mild to moderate submental fullness.
But Dr. Spiegel, although interested in the prospects, still wasn’t exactly sure what to make of the product. He had been given a briefing by the science officer at his practice, and patients had asked about it, but he was unsure of the cost details, although he knew it was expensive. Also, he wasn’t sure how many injections would be necessary per patient. Kybella is interesting and could have potential, he said, but perhaps a liposuction—which does not require multiple treatments as Kybella does and results in a relatively quick recovery time—would be just as good or better for many patients.
“A lot of the cost-benefit analysis is hard to describe at the moment, because we don’t really know,” said Dr. Spiegel.
Dr. Spiegel wasn’t alone. Several facial plastic surgeons contacted recently by ENTtoday for this article said they were not very familiar with the injections. The facial plastic surgery field is still in the feeling-out stage with this potentially game-changing treatment. But that is likely to change soon, as training takes place around the country and physicians understand more about how to use the injections.
Kybella is a nonhuman, nonanimal formulation of deoxycholic acid, a molecule that occurs naturally in the body.
Facial plastic surgeons who have experience with the injections say the cost ranges from $1,000 to $2,400 per treatment, depending on the size of the area to be treated. Two to four treatments are generally needed, so the grand total can vary widely, from $2,000 to more than $9,000—more than liposuction in many cases. As with liposuction, insurance is unlikely to cover the treatment.
The results of Kybella trials have been compelling. A post hoc pooled analysis of two large phase 3 trials of the treatment, which went by the name ATX-101, found that patients getting either of two doses showed significant improvements compared with a placebo (Plast Reconstr Surg. 2014;134:123).