Obesity might be sometimes overlooked as a disease that needs immediate attention, but the reality is it's a serious condition that can lead to a host of life-threatening conditions.
Per the Mayo Clinic, obesity can lead to an increased risk of developing high blood pressure, high cholesterol, type 2 diabetes, nonalcoholic fatty liver disease, heart disease, stroke, and even cancer, to name a few of a laundry list of possible complications. What's more, the Centers for Disease Control and Prevention notes that more than one in three adults in the U.S. are considered obese based on the body mass index, with another one-third also classified as overweight. In other words, if America's waistline doesn't stop expanding, the number of secondary conditions that develop as a result of obesity could soar.
A trio of answers to obesity
Since the summer of 2012 we've witnessed the approval of three oral weight control management medications by the Food and Drug Administration: Qsymia by VIVUS (NASDAQ:VVUS), Belviq by Arena Pharmaceuticals (NASDAQ:ARNA), and lastly Contrave by Orexigen Therapeutics (NASDAQ:OREX) which was very recently approved. Each therapy arguably offers something attractive that the others don't.
In clinical studies, Qsymia offered patients superior weight loss compared to the other two approved therapies. After one year at the recommended dose, patients lost an average of 6.7% of their weight. At the highest dose the weight-loss average climbed to 8.9%. On the other hand, Arena's Belviq offers a superior level of safety to Qsymia, as well as a prominent licensing and marketing partner in Eisai. Lastly, Contrave blends both the efficacy and safety aspects of the other two therapies and adds a nearly completed, long-term 8,900-person cardiovascular study known as the Light Study which demonstrated the safety of Contrave in an interim analysis.
Despite a clear need for weight control management products, both Qsymia and Belviq have largely flopped. Both drugs failed to get their foot in the door in Europe (albeit Contrave received a favorable review in Europe and very well could be approved), and both have struggled to gain coverage from insurers. Even though Qsymia and Belviq aren't particularly expensive, consumers have decisively shown with Qsymia following its launch that they aren't willing to pay face value for prescription drugs.
Yet, the answer to fighting obesity may not lie with oral medications at all. Instead, a solution could lie in a medical device approved by the FDA earlier this week.
On Wednesday, microcap medical device company EnteroMedics announced the approval of its VBLOC vagal blocking therapy delivered via its Maestro device. The approval came for use in obese adults with a BMI of at least 40 to 45, or a BMI of 35 to 39 with at least one serious health-related condition, such as high blood pressure, cholesterol, or type 2 diabetes, that have previously tried to lose weight. As the press release, noted it's the first medical device of its kind to be approved in more than a decade.
What's unique about VBLOC is that it works in an entirely different way than oral meds on the market. It's an implantable device that can often be set in an outpatient procedure that controls the feelings of hunger and fullness by intermittently blocking the vagus nerve, the primary regulator of the digestive system. Best of all, the device doesn't interfere with food absorption and is reversible if the user desires. In an intent-to-treat analysis that helped lead to VBLOC's approval, patients treated with VBLOC achieved 24.4% excess weight loss after one year. Coupled with a healthy lifestyle, this new device could really make an impact.
Or will it?
Not so fast
Based on a report released by Bloomberg following the approval of the VBLOC vagal blocking therapy, the system will cost a minimum of $15,000 and could have a price tag of as much as $30,000. This puts the device pretty much on par with traditional methods of surgically controlling a person's weight. While its price might make sense when you put it in that context, it's a steep dollar figure to pay if insurers don't step up to the plate to cover the device.
Herein lies the biggest concern for EnteroMedics and VBLOC: will insurers cover the device? Qsymia and Belviq are arguably revolutionary weight-loss medicines since no other pill designed to treat obesity had been approved in more than a decade prior to their approval in 2012. Yet, neither has had much success in gaining insurance coverage. What makes anyone think it'll be any different for EnteroMedics which is bringing its extremely pricey obesity-control device to market later this year?
Initially, EnteroMedics plans to offer the device to those willing to pay out of pocket, but sales of the device could struggle not long after its release if insurers decide not to cover it.
An interesting dilemma
EnteroMedics' device could lead to an interesting dilemma among consumers, insurers, and investors. On one hand, the method in which VBLOC works by intermittently blocking vagal signals may lead to superior weight loss results than current oral meds can provide. Then again, its price could be a serious deterrent.
Another possible option here is to patiently wait on the sidelines for data on Zafgen's (NASDAQ:ZFGN) beloranib. This oral med is a blocker of MetAP2 enzymes, and rather than trying to effect weight-loss via appetite reduction it works by regulating the production of fatty acids.
The downside to beloranib is we're unlikely to see it reach pharmacy shelves (assuming it proves effective in large clinical studies) prior to late 2018 or 2019. That's a long time for consumers, insurers, and investors alike to wait.
My initial suspicion is that VBLOC will receive some level of coverage by insurers since it represents a pretty dramatic leap forward in patient care beyond just traditionally offered surgical options. However, I don't believe we'll see widespread insurance coverage on the device, making access to VBLOC potentially hit and miss through its first year or two.
Either way, this is an exciting new approval, and it's another step forward by researchers in their attempt to help consumers turn the tide on obesity in America.