Prescription Digital Therapeutics

Prescription digital therapeutics (PDTs) are explored in behavior-driven conditions, such as substance abuse disorders.

The digital therapy product combines cognitive behavioral therapy with financial incentives to encourage abstinence. Lack of side effects may be a selling point.

GrayMatters Health hopes to use its technology for other mental health indications in the future.

People in urban and rural areas saw similar improvement from a digital health program that comprised patient education, an exercise program, and cognitive behavioral therapy.

The development comes after a study showed users had four fewer days per month with migraine symptoms.

By clustering patients based on self-reported data, investigators said they may be able to predict which patients are most likely to respond to a digital therapy.

The goal of the application programming interface (API) is to ensure accurate data collection without burdening patients or biasing the data.

Leaders of the Digital Therapeutics Alliance hope to get a Congressional Budget Office score on the legislation that would extend Medicare coverage so members of Congress can weigh budget implications.

Digital therapeutics are regulated like devices by the FDA. Andy Molnar, the CEO of the industry’s trade organization, the Digital Therapeutics Alliance, says the FDA clearance and authorization process for digital therapeutics “works.”

A new study showed a smartphone app is associated with improvements in HbA1c levels and other measurements indicative of well-managed diabetes. The authors note, though, that benefit may come from greater physician involvement with patients and other factors related to the app.

The trade association began lobbying in 2019.

Digital therapies for migraine have been studied extensively in recent years, and the number of products on the market is likely to expand.

Developer of EndeavorRx, a game-based treatment for ADHD, is pulling back from the pipeline and focusing on near-term growth, the CEO said in an email to employees.

Pear also recently announced a deal with California's Medicaid program that involves supporting a pilot project to help people with stimulant use disorder.

Medi-Cal, California's Medicaid program, has contracted with Pear Therapeutics for members in 24 counties to participate in an outpatient program for stimulant use disorder.

A small (23 patients) pilot study showed improvements symptoms and quality of life.

The company has made digital health a major focus of its research pipeline in multiple sclerosis.

The Access to Prescription Digital Therapeutics Act has bipartisan support.

Members who receive healthcare through Point32Health Inc.’s programs will now be able to access a device called Nerivio.

Kelly Price, vice president of market access for Mahana Therapeutics, compared the difference between digital therapeutics, prescription digital therapeutics and how FDA approval factors into that difference. She also shared what's hopeful and what's to come as far as coverage decisions, rule changes and FDA guidance for digital therapeutics in 2023.

The partnership between the North Dakota healthcare system and Orexo, a Swedish digital therapeutics company, may be an example of how digital therapeutics can be especially beneficial for healthcare systems serving rural areas.

The new device collects some information automatically but also relies on patient reports of measures like well-being.

Serge Marchand, Ph.D., of Lucine told his employer that doing scientifically rigorous trials of digital therapeutics was “going to take a little longer, and it's going to be costly.”

Akili says the underlying technology of its AKL-TO1 product (marketed in the U.S. as EndeavorRx) is “disease agnostic” and may be used as a treatment for a variety of conditions.

The arrangement represents both a solution to an unmet medical need and a new market opportunity for the digital therapeutics firm.

The virtual format is catching on but has important limitations which make it unsuitable in certain situations.

Like many digital therapeutics, the Better Therapeutics product is based on techniques used in cognitive behavioral therapy. The prescription digital therapeutic is designed to help people with diabetes modify their behaviors and eating patterns to bring down their A1c levels.

Patients use a smartphone camera to read results from a test strip. An app uses colorimetric analysis, computer vision and artificial intelligence to interpret the results.

The company is working with three digital healthcare companies during the pilot phase of the platform.

The report highlights the gap between rigorously tested prescription digital therapeutics and products that make health or economic claims without providing supportive evidence.