University of Wisconsin–Madison

Digital Therapeutics: The Medicine of the 21st Century?

Over the last decade, digital therapeutics have harnessed technology to create opportunities to supplement, and in some cases, replace traditional clinical therapy.

What are Digital Therapeutics?

In September 2017, the Food and Drug Administration approved reSET, a mobile application (app) that doctors treating addiction could prescribe, just like medication. Patients receive lessons via the app to help them modify their behavior, and eventually overcome cocaine or amphetamine dependence. Traditionally, addiction has been treated with medication and psychotherapy or behavioral interventions. Now there is a third option: digital health devices, software and mobile applications—collectively known as “digital therapeutics.”

Digital therapeutics (DTx) “deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions,” according to the Digital Therapeutics Alliance. There are two main categories of DTx: those designed as a complement to medication and/or behavioral interventions, and those aimed to replace traditional approaches altogether.

Digital Complement to Pharmacotherapy

Voluntis, a medical technology company, creates disease-specific applications that accompany and optimize the value of pharmacotherapies in diabetes and oncology. Through the app, a patient can document observations, and in turn, the application makes recommendations regarding dosage, necessary behavior changes, and when to contact a physician.

A Total Replacement

Sleepio, a web-based program to address insomnia, falls into the second category of DTx—therapies that could potentially replace traditional pharmacotherapy. Sleepio is a six-week intervention delivered by an animated sleep expert (The Prof) and his narcoleptic dog (Pavlov). Big Health, the creators of Sleepio, argue that the demand for providers trained in cognitive behavioral interventions for insomnia easily surpasses the supply, so patients suffering from the disorder often end up receiving a sleeping pill. Big Health’s goal is “to create a new digital medicine that can replace sleeping pills.” A study of more than 3,700 participants showed improved sleep and mental health after using the app.

Failure to Launch?

However, these impressive results have not pushed DTx into the medical mainstream. There is still a relatively small number of physicians prescribing digital therapies and patients using them.

For consumers, digital therapeutics remain undistinguishable from wellness apps and devices. While wellness apps and devices are marketed directly to consumers, DTx are grounded in clinical evidence and follow an R&D path that eventually leads to regulatory approval. It is a similar distinction we make between pharmaceuticals and supplements. As digital therapeutics continue to meet the standards of regulators, and the FDA’s evaluation of DTx clarifies what is safe, effective, and providing of therapeutic value, these products will gain enough differentiation in the digital health segment.

The jury is still out on how or if pharmaceutical companies will embrace DTx into their portfolios.

Pharmaceutical companies often engage in long, expensive R&D processes. Nevertheless, digital solutions demand a faster, nimbler approach, coupled with an iterative design process that incorporates user feedback. In spite of these fundamental differences, the potential for synergy is undeniable. ‘Digital medicine’ companies are ad hoc enterprises. Traditional pharma companies may not have the expertise or infrastructure to develop digital therapeutics, but have extensive experience in clinical trials, regulatory affairs and the FDA approval process.

Under the traditional model, pharmaceutical firms receive protection from competition in the form of patents. Apps and devices do not receive the same protection. This presents a new and different scenario from what’s been familiar for pharma companies. Digital therapeutics may offer some solutions to healthcare quality and cost, so it will be interesting to see how tech firms and pharmaceutical companies behave under this new paradigm, and whether it brings about partnerships/collaborations.

What’s Next?

Pharma’s reaction to DTx may have been initially tepid, but it seems to be changing.

Bayer has struck up a licensing agreement with One Drop to use the company’s diabetes management platform, aiming to boost medication adherence among Bayer customers. Higher adherence may translate into better health, but will also increase Bayer’s revenue via more regular drug refills.

Sanofi has partnered with Happify Health to develop a prescription digital therapeutic for depression treatment among people with multiple sclerosis. Their ultimate goal is to bring an FDA-approved, mental health DTx to market.

We will likely see more of these partnerships, as pharmaceutical companies discover the potential of digital therapeutics to expand revenue streams and potentially offset the high costs of drug development.


Digital Therapeutics Alliance. (2019). What are digital therapeutics? Retrieved from

Hendrickson, Z. (2019, September 19). Big Pharma is breaking into the $3 billion digital therapeutics market. Business Insider. Retrieved from

McKinsey & Company. (2018). Digital therapeutics: Preparing for take-off. Retrieved from

U.S. Food and Drug Administration. (2017, September 14). FDA permits marketing of mobile medical application for substance use disorder [Press release]. Retrieved from

Weir, K. (2018, November). The ascent of digital therapies. Monitor on Psychology, 49(10).