The first pediatric patient I saw was in 2010, while I was still a college student scurrying after attendings within the pale eggshell walls of a greater Phoenix hospital. The kid wasn’t much younger than I was, either 14 or 15, but he was just moody enough that I felt like 18-year-old me was old and gray in comparison.
The boy was suffering from bipolar disorder, but, despite instruction from his physicians and nudging from his parents, refused to take his medications. I couldn’t help but notice that throughout the visit, where I stood quietly in the corner of the outpatient clinic room, his eyes were glued to the screens of his Nintendo DS. The fleeting sounds springing from the console were just loud enough to fill the room and make the rest of us mildly uncomfortable.
I could relate. As a college freshman, my weekends were bookended with rounds of Super Smash Bros. and FIFA with friends across the hall. If only Mario Kart could treat his condition, I thought.
Eight years later, I couldn’t have imagined that the nascent field of “digital therapeutics” might just make that offhand thought a reality.
Pear Therapeutics’ CEO Corey McCann defines digital therapeutics as “patient-facing software intended to treat disease.” Digital therapeutics founders argue that their programs take advantage of our brain’s neuroplasticity — the ability for neurons in the central nervous system to ‘rewire’ themselves and result in neurochemical changes — to drive a clinical effect. This mechanism of action lends itself well to treat health problems that have an evidence-based behavioral or psychological mode of management, such as cognitive-behavioral therapy. The ideation, development, and testing of digital therapeutics mirrors that of traditional pharmaceuticals, with the distinction that, instead of small molecules, algorithms and user experience are the assets. Software could thus be taken down the typical path of a drug pipeline and receive a drug-like reimbursement.
What does this look like in practice? An interesting example comes from Akili Interactive Labs, a company building action video games to treat pediatric ADHD. Their premise is that sensory stimuli from action and adventure video games activates attentional networks in the brain at random, and tweaking algorithms and the user experience of those games ever so finely combines various sensory stimuli in a way that activates the specific region of the brain needed to treat ADHD. These pediatric patients forget that the game is medicine; they’re instead drawn into the imagery and adventure of steering down a river with aliens. Although hundreds of startups are building digital therapeutics, only a handful, such as Akili, have gone through the rigorous, large-scale clinical testing and validation to bring them up to pharma’s playing field.
In 2017, the Food and Drug Administration approved the first digital therapeutic, Reset, from Pear Therapeutics, that could be commercialized and reimbursed as a prescription drug. The product itself is a digital packaging of cognitive behavioral therapy, and acts as a monotherapy to treat addiction to alcohol, cannabis, cocaine, and stimulants. A second digital product from Pear, ResetO, is currently under priority review by the FDA and hopes to be approved as a combination therapy with buprenorphine for opioid use disorder. Other companies with rigorous, promising clinical data include Virta Health for patients with diabetes, Omada Health for patients with prediabetes, and Propeller Health for patients with asthma and COPD.
While digital therapeutics may look just like any iPhone app at first glance, that’s not quite the case behind the scenes.
Many digital therapeutics companies have been building teams and workflows modeled off the traditional drug development process, including having products pass through a specialized pipeline: research and development teams, quality groups, clinical study groups, and regulatory filing groups. Naturally, this process requires larger investments and more rigorous development cycles than traditional consumer software. Notably missing among most is the large sales force that Big Pharma is known for, which may explain why the majority of digital therapeutics products are still unfamiliar to most physician’s ears, even in Boston and San Francisco. These startups have begun partnering with large pharmaceuticals to bridge that gap, but would like to eventually grow to the point where those partnerships are a bonus rather than a requirement for their products to spread through the market.
But will FDA approvals and peer-reviewed publications be enough to convince doctors to prescribe these? Will patients give digital programs their health information in an era where privacy scandals among U.S. technology giants has eroded the public’s trust?
Getting to that stage itself is hard enough. Moving products through regulatory approval, not to mention persuading health insurance companies to reimburse them, is incredibly long and laborious. Not only do insurers have to trust fledgling startups to take care of patients, but also ensure that patient data will remain private and secure. Digital therapeutics companies are hoping that clinical validation and regulatory approval will be enough to gain the trust of physicians and help them transition from seeing these products as apps to digital medicines that will truly help their patients.
The biggest challenge, however, is not physician trust or the fidelity of the technology itself, but rather the habits of patients. Patients at-large don’t yet regard software as medicine, meaning products must not only show efficacy, but also meaningfully engage their users. If 50% of Americans don’t take their medication as prescribed, what will make them want to engage with these digital programs even half as often? Only time, technology, and aliens will tell.
Nisarg Patel is a student at Harvard Medical School and the Harvard School of Dental Medicine, and cofounder of Memora Health.
