Software as medicine? Need for digital therapeutics emerges amid pandemic

The coronavirus disease (COVID-19) pandemic appears to have quickened the acceptance of prescription digital therapeutics (PDT), or software that helps treat human disease, by clinicians and patients, particularly those suffering from mental health conditions, according to experts from one of the sessions at the 2020 Virtual Forum of the Asia Pacific Medical Technology Association (APACMed 2020).

Ken Cahill, CEO and co-founder of digital mental health platform SilverCloud Health, said that the past 6 months have moved PDT forward from an “if” to a “when” sort of situation.

“As a result of COVID-19, things like stigma have been reduced lower and we’re seeing more people utilize terms like anxiety,” Cahill said, noting how the pandemic has made treatment “very difficult” but at the same time helped PDT for mental health to “move forward.”

This sentiment was supported by Corey McCann, president and CEO of Pear Therapeutics, a pioneer in PDT and the first company to receive market authorization for software to treat disease.

“The COVID-19 crisis has certainly accelerated the need,” McCann said. “I think that you would have to really bury your head in the sand to not acknowledge the way in which COVID has limited access to care for many of the patients who are affected with mental health conditions.”

He also believed that the current crisis has significantly exacerbated many mental health conditions directly, particularly in the US where one can see a “month on month” increase in overdose statistics, which is “absolutely sobering and staggering.”

“Make no mistake,” McCann said. “I think they didn’t see the data and immediately think digital, but I think that they knew they had a problem and … that they thought there was an opportunity to address that problem with all things that are digital.”

Acting as moderator of the session, Bronwyn Le Grice, CEO and founder of ANDHealth, Australia’s only dedicated digital health accelerator and commercialization support organization, asked the two experts regarding the difference between genuine PDT and “digital snake oil.”

Cahill mentioned that there are over 10,000 apps within app stores that classify themselves as mental health care and that it is a “challenge to identify the good from the bad.” McCann agreed that it is difficult for the consumer to discern what is reliable and what is not.

Le Grice then segued to the role of regulations in this scenario and if app stores should be held to account on making sure that regulated apps are differentiated from unregulated apps.

“It’s a hot topic,” McCaan admitted before elaborating on the situation in the US, wherein fairly clear rules of engagement state that “if one wants to explicitly treat disease or make explicit these treatment claims, [then] those are imminently regulatable events,” and which he further likened to the drugs versus supplements dichotomy.

“[F]rom a regulatory perspective, you’re seeing different countries in the Asia Pacific region really follow suit with the US precedent and put themselves in a position to sort of be ahead of the European regulators,” he said.

Finally, Le Grice mentioned three way on how using PDT can transform care in the future in terms of affordability, accessibility, and efficacy, which the two experts agreed on.

“They are the key things that digital is able to enable,” Cahill said. “And I think … today a lot of digital health companies who are out there … have been able to provide easier, earlier access to care.”

McCann said, “I firmly believe that that’s just the beginning, and what we’ve built in Pear is a pipeline that is next focused on specialty neurologic conditions. But this really isn’t something which is limited to disorders of the nervous system. I think you’ll see drugs … which are really poised to treat conditions well outside specialty psych, well outside specialty neuro.”