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The AspyreRx digital behavioral platform will be made available to Glooko patients
Last week, Better Therapeutics, a company developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, and diabetes management platform Glooko announced that they were partnering.
Through this collaboration, Better Therapeutics’ AspyreRx digital behavioral treatment for type 2 diabetes (T2D) will be integrated into Glooko’s diabetes management platform so that healthcare providers who use the Glooko platform can identify suitable patients for AspyreRx, facilitate prescriptions, and track patients throughout their treatment.
AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. Going forward, it will be accessible on the Glooko healthcare provider platform in the U.S. as a new treatment option.
Additionally, Better Therapeutics will leverage Glooko’s 'precision engagement' functionality to flag patients who are suitable candidates for AspyreRx.
So far, Glooko’s solutions have helped over 3.4 million people in the United States with diabetes and are utilized in nearly 5,000 clinic locations.
Frank Karbe, CEO of Better Therapeutics spoke to VatorNews about his company's mission, the partnership with Glooko, and how this will help Better Therapeutics achieve its goals.
VatorNews: Give me a brief overview of Better Therapeutics. What is the problem that you have identified and how are you solving it?
Frank Karbe: The healthcare industry to date has largely been focused on mitigating symptoms to treat metabolic diseases as opposed to addressing the root cause. We aim to change this. As a society we have spent billions on developing drugs that lower blood sugar, blood pressure, cholesterol etc. but we spend very little to address why these markers are elevated in the first place. Our Founder and Chairman, David Perry, explains it further here.
Behavior change is proven to be a powerful medicine, yet the conventional approach is not scalable. Our platform overcomes this. Cognitive Behavioral Therapy (CBT) is considered the 'Gold Standard' of evidence-based psychotherapy and is proven to help people change the course of their diabetes and other cardiometabolic diseases. However, traditional CBT is delivered through in person-therapy which is not scalable. There are neither sufficient therapists, nor is it feasible for most patients to see a therapist in-person for many weeks at a time, and even if it were, the approach would be cost prohibitive.
Amidst the proliferation of digital health tools, AspyreRx is the first and only CBT app to receive FDA authorization to treat T2D. We have developed a proprietary, software-based, CBT treatment protocol that specifically targets the behaviors known to cause and drive the progression of cardiometabolic diseases. By digitizing CBT we made it broadly accessible and affordable to anyone with a smartphone. With our focus on cardiometabolic diseases, and T2D as our lead indication, we are targeting very large patient populations with significant unmet medical needs (about 50% of patients diagnosed with T2D have uncontrolled blood sugar levels despite being on medication).
VN: Who is the typical user for Better Therapeutics? Walk me through some typical use cases.
FK: We have obtained a broad label from the FDA to treat all adult patients with T2D with AspyreRx. That said, we believe there are various stages in the disease journey of a patient where patients may be particularly well suited to utilize our product. For example, after first diagnosis or after patients have failed prior drugs and are about to be put on a new drug. Most patients at some point in their disease journey do not want to be put on another drug but just want to get better. Since AspyreRx is a prescription-only therapy its use needs to be prescribed by a healthcare provider. This includes Endocrinologists, PCPs, diabetologists, etc.
VN: What is unique about AspyreRx? How does it help change behavior in patients with type 2 diabetes?
FK: A broadly accessible, effective behavioral health intervention to help clinicians and people living with type 2 diabetes address the underlying psychological, behavioral, and cognitive factors that contribute to the development and progression of Type 2 diabetes, has the potential to change the trajectory of disease progression, including possibly reversing it - and that is exactly what is urgently needed.
With FDA authorization of AspyreRx, a new regulatory class of digital therapeutics has been established - with AspyreRx being the first prescription-only digital therapeutic treatment to provide cognitive behavioral therapy, or CBT, to adult patients with T2D.
Being a prescription digital therapeutic, AspyreRx is differentiated from general health and wellness apps in several significant ways. First, in contrast to the vast majority of digital health solutions, we undertook rigorous clinical testing by conducting a large randomized controlled trial to demonstrate safety and efficacy, demonstrating clinically meaningful and sustained reduction in HbA1c when used up to 180 days.
Second, our product is FDA authorized as a Class II Medical Device, which is critically important to ensure we, and others, meet specific standards for quality, safety, and effectiveness. It is also an important prerequisite to obtain broad payer coverage and gain the trust of providers and patients, all of which are important drivers for adoption.
Third, AspyreRx is indicated to provide treatment, versus alternative solutions offering data capture and data management software only, for tracking and monitoring for example blood glucose.
Fourth, AspyreRx must be prescribed by a healthcare provider and is designed to be integrated into the overall care management of patients. This adds an important layer of expertise and oversight, ensuring seamless coordination between the AspyreRx app, the patient, and their healthcare provider.
And finally, Better Therapeutics adheres to strict security and data privacy standards. Regulatory guidelines for manufacturers and developers of FDA cleared or approved healthcare products include requirements for protecting patient data, securing medical devices against cyber threats, and safeguarding personal health information.
VN: What kind of ROI have you been able to calculate for patients who have used AspyreRx? Do you have hard numbers you can share?
FK: AspyreRx is backed by an RCT that demonstrated statistically and clinically significant durable reductions in A1c at 90 and 180 days vs. the standard of care control group. The RCT also resulted in statistically significant improvements in blood pressure, weight, mood, and quality of life, as well as having lower medication utilization and fewer adverse events vs. the control group. You can find the full clinical trial results report here.
We ran HEOR models to show the health economic benefits of the utilization of AspyreRx. Based on our cost effectiveness analysis of our pivotal study data, AspyreRx may not only lead to improvements for patients but may also be less expensive for payers. In terms of “Cost Effectiveness” AspyreRx is categorized as a “Dominant” intervention, meaning it has the potential to be less costly and more effective than standard of care.
A study, titled "Cost-Effectiveness Analysis of a Prescription Digital Therapeutic in Type 2 Diabetes" has been published in Advances in Therapy, a prominent peer-reviewed medical journal.
VN: How did the partnership with Glooko come about? How did the two companies realize there was a way to work together?
FK: Both companies are focused on T2D and Glooko and Better Therapeutics have had a mutual respect for each other for years and have had conversations about potential ways to work together. Glooko is in many ways an ideal partner for us because their customer base highly overlaps with providers we have identified as early adopters for AspyreRx. With AspyreRx’s commercial launch in October 2023, the two companies re-engaged to find a way to partner. We look forward to a potential expansion of this partnership over time.
VNL What gap are you filling for Glooko? What will they be able to offer their customers now that they couldn't before partnering with you?
FK: Glooko will now be able to add AspyreRx to the Glooko Healthcare Provider Portal. In addition, Glooko will utilize its precision engagement functionality to help their healthcare provider customers to flag patients in their treatment population that are potentially a good fit to be prescribed AspyreRx. Beyond the patient flagging, healthcare providers will be provided with educational materials so they can get up to speed on this first-in-class treatment and appropriately prescribe AspyreRx to patients that are deemed a good-fit for the product.
VN: How many patients are currently using AspyreRx? How many do you anticipate will be using it now that Glooko will be offering it?
FK: Since commercial launch in October, healthcare providers have begun prescribing AspyreRx and we have patients active on treatment. Since it is still very early in the launch we have not yet disclosed any numbers. We do expect a significant boost in utilization of AspyreRx from the Glooko partnership, since the Glooko platform is used in nearly 5000 clinic locations in the US.
VN: What is your ultimate goal at Better Therapeutics? What will success look like for you and how does this partnership help you get there?
FK: Our vision is to make societies healthier and meaningfully reduce healthcare costs as the trusted choice in digital behavioral health interventions. This partnership will accelerate our ability to raise awareness for AspyreRx by reaching healthcare providers that we have identified as early adopters. And by giving these providers a tool to identify suitable patients for AspyreRx we expect to accelerate prescriptions written for AspyreRx and in turn drive progress towards our vision.
VN: Is there anything else I should know about the company or the partnership?
FK: We believe our digital therapeutics platform can rapidly be applied to a host of other cardiometabolic diseases beyond T2D. We already generated proof-of-concept data in several other indications and recently submitted a request to the FDA for breakthrough device designation to treat liver disease.
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