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Exploring the diabetes med-tech frontier

By Stacy Lawrence

Staff Writer

Weight loss on the order of just 5 percent to 10 percent can prevent or delay type 2 diabetes development. But general practitioners in the U.S. aren't routinely offering medical options to help patients get there, leaving several recently FDA-approved weight loss aiding medical devices usually off the table for treatment of even prediabetic and newly diagnosed type 2 diabetes patients.

These medical devices, dominated by a trio of balloon-based options, might seem a good fit clinically for this patient population. But instead of focusing on disease prevention or regression, the companies that market these devices must instead focus on the self-pay market, which is driven by aesthetics, and surgical preparation.

Regulatory rigidity?

That's due to an FDA regulatory process that does not define obesity as a disease state in and of itself, and pushes companies through additional regulatory hoops on obesity-related disease states such as diabetes. Without those additional, costly clinical studies, obesity devices won't be reimbursable by payers for the treatment or prevention of obesity-related diseases.

In addition, gaining FDA approvals for the treatment of obesity-related diseases has proven a treacherous, and largely untenable, path for weight loss drugs, devices and surgeries that have preceded the latest crop. And U.S. payers are typically looking at a given individual remaining within their insured pool for only two to three years on average. That makes long-term prevention efforts through weight loss aids a very tough sell.

The small companies behind the FDA-approved balloons – Obalon Therapeutics Inc., Reshape Medical Inc. and Apollo Endosurgery Inc. – are focused on building up self-pay sales first and then expect to engage more around gaining reimbursement.

"Right now, Orbera [intragastric balloon] is a cash-pay procedure, which by itself is a very attractive market in the U.S. Typically, a patient cost is determined by the physician who offer the procedure. It is typically offered in the $6,000 to $8,000 range, which of course includes placement, removal and a full 12-month program of exercise and nutritional support," Apollo CEO Todd Newton told BioWorld MedTech.

"As to traditional payer reimbursement, there are a number of avenues that we're beginning to explore. For example, we think there are a number of high-risk patient groups whose medical treatment is probably impeded by their obesity," he added noting the example of a Harvard Medical School surgeon who published about a case in The Journal of Heart and Lung Transplantation. Orbera was employed in an advanced heart failure patient who needed a transplant, but needed to lose weight first to get his morbid obesity and type 2 diabetes under control.

On the surgery side, the Centers for Medicare & Medicaid Services (CMS) has long covered surgical procedures, including gastric banding, roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch for patients with a body-mass index of greater than 35 and having at least one co-morbidity related to obesity. Type 2 diabetes mellitus was specifically added as a qualifying co-morbidity in early 2009, with the decision being issued originally in 2006.

CMS has specifically issued decisions declining to cover gastric balloons or sleeve gastrectomy, one of the more popular current surgical approaches.

In fact, the latest in bariatric surgery is a minimally invasive endoscopic sleeve gastroplasty, designed to mimic the sleeve gastrectomy. Instead of the removal of a large portion of the stomach to create a small banana-sized and shaped stomach, the gastroplasty simply staples the stomach into a similar size and shape with tissue remaining. The procedure is potentially reversible, but is not considered temporary.

While gastric balloons and endoscopic sleeve gastroplasty, which is conducted with San Diego-based Apollo's Overstitch Endoscopic Suturing System, may be the latest in FDA-approved weight loss technology, they won't be systematically aiding diabetes patients in the U.S. any time soon.

Aided by the CMS coverage determination, the Lap-Band peaked in 2008 with almost $300 million in sales until it was overrun by long-term safety issues and disappointing efficacy. Its path to those heights started with a 2001 FDA approval, giving it a seven year run-up to its top annual sales.

Lean launches

Today's obesity devices are nowhere near those sales heights. Apollo Endosurgery had only about $65 million in revenue, of which $31.9 million came from its endo-bariatric tools Orbera and Overstitch with the remainder coming from the Lab-Band, which it purchased from Allergan Inc. in 2013 for up to $110 million.

Apollo remains a tiny company, worth only about $75 million, reflecting investor skepticism that its products will soon gain traction. It remains in the midst of training physicians to use Orbera, which was approved by the FDA in August 2015. The initial focus has been on bariatric surgeons and gastroenterologists; Apollo had trained more than 850 physicians as of March 30 in the placement of Orbera. There are about 3,500 bariatric centers in the U.S. But now the focus is starting to shift to educating consumers, as well as exploring other potential markets such as aesthetics.

"The main effort though is starting to shift away from just training doctors towards now looking at how do we make people who are otherwise seeking solutions for weight loss understand the challenges that they face. How do we get those people to better understand the opportunities that gastric balloon therapy can provide them?" Newton wondered.

The FDA-approved weight loss balloons all vary slightly and resulted in about 7 percent to 10 percent of body weight lost in pivotal data after the permitted six months of use.

Above the high-end of that range in pivotal data for patients with a body mass index (BMI) of 30 to 40, Orbera is a single endoscopically placed balloon that is then filled with saline. According to the latest statistics from the Centers for Disease Control, more than one-third of U.S. adults have a BMI of 30 or higher.

Orbera has been used in 220,000 patients, having long been approved in Europe and elsewhere. Serial use of the balloon, for more than one six-month period, has been common. In the U.S., Apollo claims it already has a strong market share, with every 3.5 to 4 balloons out of 5 placed being Orbera balloons.

Swallowing the alternatives

Competitors San Clemente, Calif.-based Reshape Medical and Carlsbad, Calif,-based Obalon Therapeutics would like to gain market share on Orbera. Obalon has the most recently approved weight loss balloon. Rather than being placed endoscopically, like the other two marketed balloons, Obalon's is swallowed as a capsule and then inflated via catheter with air. But, like the others, it must be deflated and removed endoscopically. It was just approved last fall.

Up to three Obalon balloons of 250 mL can be placed gradually over the six month treatment period. Orbera's balloon holds 400 mL to 700 mL, while Reshape's device is two liquid-filled balloons of up to 450 mL each. Obalon is priced similarly to Orbera, the $6,000 to $9,000 range is the patient's all-inclusive sum.

Like Apollo, Obalon isn't targeting reimbursement for diabetes or any other disease treatment any time soon. It's launched into three channels: bariatric surgeons, gastroenterologist and plastic surgeons. On the diabetes front, it's interested in corporate wellness programs.

"There is no wellness without weight loss. The fundamental key in this country to having wellness is to get weight loss. We have a product that fits the lifestyle of these people. It is beginning to be priced in an affordable range based upon aesthetic procedures," said Obalon President and CEO Andrew Rasdal. "I think, over time, as the technology and clinicians improve and there's more people doing it, I think it will only get more affordable for patients. So, if people are waiting for a reimbursed weight loss solution, I think they have a very long time to wait," he told BioWorld MedTech.

"Employers are increasingly becoming concerned about wellness; they tend to adopt these programs about weight loss," he added noting how many people with type 2 diabetes could reverse the disease with weight loss. Rasdal was previously the CEO of Dexcom, but has led Obalon since 2008.

Up next on the obesity device front in the U.S. may be Allurion Technologies, which has a CE mark for its Elipse that is both swallowable, filled with liquid and then, once deflated, is excreted after four months of use. European data in 34 patients with a BMI between 27 and 40 showed an average weight loss of 22 pounds.

Natick, Mass.-based Allurion was founded in 2009 by a pair of Harvard Medical students. It's planning a U.S. pivotal trial, but has yet to start one. Obalon's Rasdal argues that Allurion is at least three to five years from being on the market in the U.S.

Published  July 7, 2017

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