Right on schedule, after securing FDA de novo clearance for its digital therapeutic designed to help manage Type 2 diabetes, Better Therapeutics is beginning the commercial launch of the app.
When it announced the regulatory clearance in July, Better said it would begin rolling out AspyreRx in the fourth quarter of the year—and indeed, the company announced Monday that U.S. doctors are now free to prescribe the digital therapeutic to their patients with Type 2 diabetes, who can then download the app to their personal smartphones through Apple and Google’s app stores.
The program is indicated for prescription use only by people aged 18 and older with Type 2 diabetes.
“With the launch of AspyreRx, providers now have a clinically proven treatment delivered in an easily accessible, engaging and affordable way. Behavior modification can be powerful medicine that is valuable at any stage of the disease and since it is already included in current treatment guidelines, we envision AspyreRx becoming part of the standard of care for adults with T2D,” CEO Frank Karbe said in the release.
AspyreRx delivers a form of cognitive behavioral therapy (CBT) in an effort to improve the health of people with diabetes, by helping them understand how behavioral changes—guided by regular therapy sessions, skill-building lessons and goal check-ins—can improve their blood sugar levels and other physical health outcomes.
In a study of more than 600 participants—the results of which helped Better land de novo clearance—those assigned to use the app experienced statistically and clinically significant reductions in glucose levels compared to the control group, while also racking up improvements in their blood pressure, weight, mood and quality of life.
About half of that group saw their HbA1c drop by an average of 1.3 percentage points after six months, with better health outcomes linked to higher engagement with the app, according to the company.
After spending about a decade developing the technology behind AspyreRx, with its first FDA nod secured, Better now plans to adapt the CBT technology for use in treating other health conditions. That includes upcoming plans to submit an application for FDA breakthrough device designation for the use of its technology in nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.
Though Better has said that its digital therapeutics are intended to be “reimbursed like traditional medicines,” the AspyreRx app doesn’t yet have broad coverage from insurers—a widespread issue that has taken a serious toll on digital therapeutics makers in the last year—so it will initially be available on a cash-pay basis.
During the company’s second-quarter earnings call in August, Karbe and Diane Gomez-Thinnes, chief commercial officer, discussed Better’s efforts to appeal to payers to cover the technology.
As of that conference call, Better had met with several insurers, with more meetings planned for the following weeks, according to Gomez-Thinnes, who added that the “feedback has been encouraging as payers recognize the unmet needs that exist in Type 2 diabetes and are looking for ways to control the escalating costs associated with this patient population.”
The list price of AspyreRx is set at $750 per 90-day treatment, and Gomez-Thinnes noted that most patients will get at least one “refill,” putting the cost at $1,500 for six months—though she added that patient costs will likely be lower than that, whether or not the app is covered by insurance.
“Through our distribution pharmacy partner, claims will be processed to demonstrate demand for payers. For patients who may have claims rejected by insurance, we will offer, for a limited time, a reasonably priced cash-pay option with a focus on maintaining low patient out-of-pocket costs,” Gomez-Thinnes said. “We expect this to yield several benefits, including doctors gaining experience and confidence in prescribing AspyreRx, patients being able to access the treatment and Better Therapeutics generating initial revenue.”