Digital Therapeutics Alliance Has Doubled in Size

First of three parts

Telehealth and remote care boomed amid the COVDI-19 and so did the trade association representing the growing industry’s interests in Washington.

“It’s been pretty incredible. Since I joined, I think we have doubled in membership,” says Andy Molnar, CEO of the Digital Therapeutic, who took the reins of the organization in July 2021. Molnar and Sara Elalamy, the group’s director of U.S. government affairs, were recently interviewed by Managed Healthcare Executive.®

The list of members on the Digital Therapeutics Alliance website currently includes 107 companies. A large number are companies that have developed digital therapeutics, including those with fairly high profiles, such as Pear Therapeutics, Dario Health and Cognoa, Molnar’s former employee (he also had a short stint at Pear).

But the alliance’s membership also includes many of powerhouses of the pharmaceutical industry, such as Novartis, Biogen, Sanofi, Bristol Myers Squibb and Bayer.

“A lot of times these pharma companies are either partnering with digital therapeutics companies or are building products on their own,” says Molnar. “You can’t necessarily think of them as a pharmacologic companies anymore. You have to think of them as threating the whole spectrum of disease.”

Molnar says the rush of venture capital into digital therapeutics and telehealth was “off the charts” in 2021 and as the industry grew, so did the trade association. He doesn’t expect a repeat. “I wouldn’t expect that year over year,” says Molnar. “2021 and into 2022 were just years when I think everybody realized that remote care, and bringing care to the patient, is incredibly important.”

The trade association also loosen it criteria for membership, admitting, for example consultants. “They had their hands in everything and so we were missing this major piece of groups that were really adding to the initiative of getting these products in the hands of patients,” says Molnar.

Molnar says the alliance now uses adherence tothe group’s 10 “core principles” for digital therapeutics as the criteria for membership. Some of the principles on that list include that the therapeutic must be designed to prevent, manage, or treat a medical disorder or disease; must be “driven” by software; and must be “reviewed and cleared or certified by regulatory bodies as required to support product claims or risk, efficacy, and intended use.” Publishing trial results in peer-reviewed journals and collecting and analyzing real-world evidence are also on that list

Molnar said the alliance wouldn’t turn away a company with a mobile health product that hadn’t been “clinically validated” if the company was interested in learning how to do so.

“But if somebody came to us and said, ‘We’re doing only mobile health products, were not doing any clinical validation, we are telling people that we can help them even though we can’t prove it,’we’re not necessarily going to say don’t be a member, but it is not going to be a good fit. They’re not going to get anything out of us. And, frankly, our whole membership will be telling them constantly that what they’re doing is not right.”

The Digital Therapeutics Alliance was founded in 2017. Molnar says it registered as a lobbying organization in 2019 when it became clear that Medicare reimbursement would require a change in law. “CMS said the only way these products can be reimbursed (by Medicare) is through an act of Congress and so then lobbying came into play. It wasn’t necessarily a core function of why were founded. We thought we could work through CMS and other government agencies without that (lobbying) but then it turned out it was completely necessary to help move this industry forward.”