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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.
The Data
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).
A total of 1,022 patients participated in the trials—514 received ATX-101 and 508 received a placebo. More than 68% of patients reported at least a one-point improvement on a composite of the clinician- and patient-reported Submental Fat Rating Scale, which uses a 0 through 4 scale. That compared with 20.5% in the placebo group (P<.001). Sixteen percent of the treatment group reported an improvement of two points or more, compared with 1.5% in the placebo group (P<.001).
The most common adverse events were pain, swelling, bruising, and numbness, but most were transient and expected due to the nature of the treatment,
researchers reported. In the trials, 4% of patients had facial nerve injury that caused an uneven smile or muscle weakness, but those symptoms resolved.
Kythera, which is expected to be bought by Allergan in a $2.1 billion deal, says the injections should be used with caution in patients with bleeding abnormalities and in those who are on anticoagulants (The Wall Street Journal, August 5, 2015). The company also cautions that it should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.
Ed Williams, MD, founding physician at the Williams Center Plastic Surgery Specialists in Albany, N.Y., and the president-elect of the American Academy of Facial Plastic and Reconstructive Surgery, said he was initially “very skeptical” of Kybella. But after speaking with the company’s founder and becoming a paid trainer, he now thinks the treatment has a place in the field. He has treated approximately 25 patients and, using a topical anesthetic and lidocaine and a thin, 30-gauge needle, has been able to make the procedure pain-free, he said.
“One could say, wouldn’t you be better with liposuction?” he said. “And the answer is, there are a lot of people who just don’t want surgery. They want something nonsurgical.”
He acknowledged that the treatment is “not inexpensive” and that with multiple injections the cost can add up quickly. But some patients will still prefer the procedure over liposuction, he said. “I learned years ago not to get into consumers’ heads, because just when you think you’ve got it figured out, something different happens,” he added.
The ideal patient is someone with mild to moderate submental fullness, or double chin, but not a very heavy or full neck, he said. Patients will typically be 30 to 50 years old; the treatment for those who are older than that is usually too extensive for Kybella, although there are exceptions, Dr. Williams said. A grid is placed over the treatment area that marks where the injections are to go, so the procedure is not technically difficult, he added.
Carlos Wolf, MD, a facial plastic surgeon with Miami Plastic Surgery in Florida, said he was skeptical of the treatment as well, but after a recent training session, he now thinks it has a place in treating carefully selected patients—generally those in their 20s to 50s with good skin elasticity. One consideration is that patients need to wait a month between injections for the effects to be seen. “They’re not going to get instant gratification; it’s going to take them one, two, three, or four months to get where they want to be,” he said.
As for safety, “The reality is that the area that they’re talking about is really a very specific area bordered by fairly safe territory,” he added.
The price is fairly high, he said, but he thinks it’s possible the company might have to make some adjustments after the treatment gains some traction. He said his practice hasn’t settled on pricing, but one possibility is that practices will offer a global price, with the cost of each treatment falling below that amount and some above it.
Dr. Spiegel said he wonders about the drug’s potential uses beyond double chin treatment. “Just like botulinum toxin came out with one indication [and] has now expanded to many, many uses, I think the creative minds of facial plastic surgeons will start thinking about ways to use this new tool,” he said.
Dr. Williams said he thinks Kybella will be “expanded upon in other areas.” Dr. Wolf said he can already think of several ways the treatment might be used off label. But those other uses might be slow to emerge. In announcing its approval, the FDA cautioned that Kybella is only approved for under-the-chin fat treatment and that “it is not known if Kybella is safe or effective for treatment outside of this area.”
Thomas Collins is a freelance medical journalist based in Florida.