As advancements in technology-assisted treatments evolve, digital therapeutics are emerging as a vehicle for mental health and addiction treatment. Digital therapeutics have the potential to close gaps in care for patients, reduce demands on providers’ time, and enhance the effectiveness of pharmaceuticals, offering promise for stakeholders across the spectrum of healthcare delivery.

What are digital therapeutics?

Digital therapeutics are evidence-based therapeutic interventions driven by software programs to prevent, manage, or treat a specific disease or disorder. Unlike health and wellness apps, digital therapeutics follow a research and development path similar to drug development. The technology-driven treatments are evaluated in clinical trials and prescribed by a medical provider. Digital therapeutics can be used as a standalone or adjunct therapy. Many of the companies developing digital therapies are seeking regulatory approval for their products.

Digital therapies could play a unique role in tackling addiction 

The first two FDA-approved digital therapeutics are Pear Therapeutics’ Reset mobile medical application for substance use disorders and Reset-O, which is specifically for opioid use disorder. Both tools require a prescription and provide cognitive behavioral therapy as an adjunct to outpatient treatment under the supervision of a clinician. Reset-O is also intended to be used in conjunction with pharmacotherapy.

Clinical trial data showed that Reset, when used with outpatient therapy and contingency management, significantly increased abstinence from alcohol, cocaine, marijuana, and stimulant substance use and increased retention as compared to outpatient therapy alone. Study data also demonstrated that Reset-O, used with buprenorphine, significantly improved opioid use disorder patient retention rates in outpatient treatment.

Opportunities for healthcare stakeholders

Digital therapeutics hold promise for stakeholders across the spectrum of healthcare delivery.  Implications for patients, providers, payers, and pharma include the following:

Patients - Digital therapeutics could expand access to care for underserved populations by overcoming challenges that limit the delivery of healthcare services, such as provider shortages. Digital therapeutics also offer convenience to patients, which could encourage adherence to treatment regimens.

Providers - Digital therapeutics could save providers time, enabling greater efficiency in the delivery of healthcare services. In clinical trials, Reset-O showed the ability to reduce required clinician intervention time in opiate dependence. Collection of real-time data via mobile medical tools also could offer opportunities for immediate intervention while monitoring patient progress and provide data that is more accurate than data obtained via retrospective recall.

Payers - Digital health technologies could support chronic disease management, helping to prevent disease progression and decrease overall costs for payers. Digital therapeutics could also deliver more cost-effective care by reducing demand on providers’ time. In addition, by using technology to scale evidence-based treatments to a broad patient population, digital therapies could lead to better value-based contracts and pricing models. For instance, subscription pricing models for technology-based treatments could accelerate patient access and make spending more predictable.

Pharma - Digital therapeutics could help drug makers and marketers increase the effectiveness of conventional pharmaceutical therapies by encouraging patients to adhere to prescription drug regimens. Reset-O, for example, allows providers to track patients’ adherence to buprenorphine. The data from digital therapeutics also creates opportunities to present real-world evidence of clinical efficacy to payers to prove the value of their products.

Selected digital therapies for behavioral health

Pear Therapeutics is currently the only company to have brought a digital therapeutic for behavioral health to market, but other companies are making progress in this space.


Looking ahead

Pear Therapeutics is now working to demonstrate clinical uptake, effectiveness, and the ability to be reimbursed by payers. Depending on its success, the commercialization of Reset and Reset-O could serve as a model for other prescription digital therapies targeting mental health and substance use disorders.

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