Modeling Finds FDA-Authorized Diabetes Digital Therapeutic Can be Cost-Effective

The type 2 diabetes digital therapeutic, AspyreRx, plus standard of care helped patients better manage their diabetes and provided economic value over standard of care alone, finds a new study published in Advances in Therapy.

The FDA had authorized AspyreRx in July 2023. It is a prescription digital therapeutic that uses cognitive behavioral therapy to help patients with diabetes lower their HbA1c. Through interactive lessons, skill-building modules and weekly goal setting and tracking, patients can connect changes in behavior to improvements in blood sugar and other biometrics.

The regulatory authorization was based on a clinical trial involving 668 patients; half achieved a mean A1c reduction of 1.3% after six months of usage. It has a list price of $750 for a 90-day prescription

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Niall J. Davison

In the Advances in Therapy paper, researchers — led by health economist Niall J. Davison, senior scientific lead at Maple Health Group, a consulting company in New York — modeled the cost-effectiveness of AspyreRx plus standard of care versus standard of care alone in type 2 diabetes over a lifetime horizon. The analysis followed the modeling established by the Institute for Clinical and Economic Review (ICER) for the appraisals of type 2 diabetes medications. The study was sponsored by Better Therapeutics, which developed AspyreRx.

In the study, a three-month cycle length was used to capture and assess the costs associated with AspyreRx, and clinical experience was estimated each cycle. Patient outcomes were simulated individually and aggregated. The model also included 610 patients to match the intent-to-treat population from the clinical trial in which AspyreRx’s authorization was based on.

The standard of care used in this model included oral and injectable treatments that patients in the AspyreRx clinical trial received. These include metformin, DPP4 (an oral class of glucose inhibitors), GLP-1, and insulin.

Researchers found that AspyreRx plus standard of care was associated both with gains in quality-adjusted life years (QALYs) and cost savings of $7,343 per patient over the lifetime horizon. Additionally, AspyreRx plus standard of care was cost-effective at a willingness-to-pay of $100,000 per QALY over standard of care alone, with an incremental net monetary benefit of $17,443. Savings were primarily driven by a reduction in drug costs, followed by reductions in adverse event costs.

“This study adds to the growing body of evidence supporting the potential efficacy and economic viability of digital therapeutics,” Davison said in a press release. “In an evolving landscape where technology converges with healthcare, recognizing the cost-effectiveness of integrating digital therapeutics into mainstream clinical practice is crucial in driving sustainable solutions that can benefit both patients and the overall healthcare system.”

Researchers indicated that limitations include the use of short-term data. At the time of this modeling, AspyreRx had not been used beyond 180 days. A second limitation was the use of data from the clinical trial, which researchers said may not reflect real-world clinical practice. Additionally, researchers said that the complexity of diabetes can make it challenging to make reliable predictions.