In 2020, the Food and Drug Administration cleared Akili Interactive’s video game to improve attention in kids with ADHD. It was the first time that a video game for treatment was cleared by the agency, and is one example of a digital therapeutic, a class of software-based treatments with FDA indications.
Now, as the market is further developing, these companies have built up big ambitions.
Corey McCann, the CEO of Pear Therapeutics, which has three FDA-cleared digital treatments, hopes to make them the standard of care and garner widespread insurance coverage. After going public last year, Pear aims to increase its revenue 30-fold by 2023, based on expectations that more insurers will cover its products, and more physicians will write prescriptions.
However, it remains to be seen whether they will be able to achieve these goals, or sustain the costs that come with developing a new class of treatments.
While getting FDA clearance was a first step, experts identified several hurdles ahead, including getting physician uptake, building pathways to reimbursement, and importantly, developing software that patients will want to use.
“There’s still a lot of foundational work that needs to be done,” said Maya Desai, director of life sciences for Guidehouse. “There’s a lot of behavioral change that needs to happen across the stakeholders and their mindsets to think about digital therapeutics as a category of its own.”
Differentiating from wellness apps
One early challenge has been distinguishing digital therapeutics from other software products.
In a market saturated with hundreds of thousands of health and wellness apps, many of which are clamoring for benefits executives’ attention, companies that have garnered clinical evidence are looking to set themselves apart. Some, such as Pear, have started referring to their products as “prescription digital therapeutics,” or PDTs.
There’s also substantial overlap, as many digital therapeutics are focused on behavioral health, which has also been a top area of investment among digital health companies. A few companies are considering other modalities, such as Voluntis, which got FDA clearance in 2019 for its software to help cancer patients manage their symptoms, and AppliedVR, which got FDA clearance last year for virtual reality-based cognitive behavioral therapy to treat chronic lower back pain.
