Better Therapeutics is officially launching its digital therapeutic app, AspyreRx, for managing Type 2 diabetes after securing FDA de novo clearance. U.S. healthcare providers can now prescribe this innovative solution to patients aged 18 and older, who can easily download the app via Apple and Google’s app stores.
AspyreRx stands out as a clinically proven treatment that offers accessibility, engagement, and affordability. The program leverages cognitive behavioral therapy (CBT) to empower individuals with Type 2 diabetes to make behavioral changes that enhance their blood sugar levels and overall physical health outcomes. Regular therapy sessions, skill-building lessons, and goal tracking all contribute to the app’s effectiveness.
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A pivotal study involving over 600 participants played a vital role in obtaining FDA clearance. The results showcased statistically and clinically significant reductions in glucose levels, along with improvements in blood pressure, weight, mood, and quality of life for those using the app compared to the control group. Approximately half of the participants experienced a noteworthy average HbA1c reduction of 1.3 percentage points after six months, emphasizing the connection between app engagement and improved health outcomes.
After dedicating nearly a decade to developing the technology behind AspyreRx, Better Therapeutics now plans to adapt CBT technology for treating other health conditions. The company intends to seek FDA breakthrough device designation for using its technology in addressing nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.
While Better Therapeutics aims for its digital therapeutics to be reimbursed like traditional medicines, the AspyreRx app currently faces limited insurance coverage, a common challenge among digital therapeutics providers. Consequently, it will initially be available on a cash-pay basis.
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Better Therapeutics has been actively engaging with insurance providers, working to gain their support in covering the technology. The company’s proactive approach involves discussions with insurers to address the unmet needs in managing Type 2 diabetes and finding ways to control associated costs effectively.
The list price for a 90-day treatment with AspyreRx is $750, and most patients are expected to receive at least one “refill,” making the cost approximately $1,500 for a six-month period. Patient costs are likely to decrease, regardless of insurance coverage, underscoring Better Therapeutics’ commitment to providing accessible and impactful care for individuals with Type 2 diabetes.
“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.”
