Federal food and drug regulators in April issued new guidance to help expand the availability of digital health therapeutic devices for certain mental health disorders. The FDA said the "increased utilization of digital therapeutic devices may ease burdens on hospitals and other health care facilities and reduce the risk of exposure to SARS-CoV-2 for patients and health care providers."

The Lux Research report said "digital therapeutics can address rising health care costs, as the cost of a digital therapeutic subscription can be less than that of a single doctor appointment."

Danielle Bradnan, a Lux Research analyst and lead author of the new report, said health benefits advisors and managers would have two key reasons to consider digital therapeutics.

"First, they have been shown to improve clinical outcomes, equal to and in some cases over the traditional gold standard therapies because they can offer continuous on demand care across a number of health conditions—both chronic and acute," Bradnan said in an email to Benefits Pro. "Second, they can have some significant cost benefits when compared to more traditional therapeutic offerings, which have been verified by independent organizations and reported by major players such as Livongo and Kaia Health."

Some critics of digital therapeutics have called them "essentially just repackaging and rebranding [of] existing treatments," according to a 2018 report in The New York Times.

Still, investment in digital therapeutics has grown substantially over the past seven years, according to a McKinsey report in March. "Payers and providers want digital tools that help them serve greater numbers of patients more effectively and at lower cost," the McKinsey research report stated.

Theresa Juday, clinical advisor for product strategy at CVS, said during a recent webinar that digital therapeutics can help "personalize experience for patients." The technology, she said, according to a Pharmacy Technology Report, can provide care "based on the patient's schedule and in their setting—how important is that during COVID-19, when they can't get to the physician's office?"

The new FDA guidance lowered regulatory barriers "for low-risk technologies that could provide relief to individuals with anxiety, depression, insomnia, ADHD, PTSD and autism, among other psychiatric disorders," MedTech Dive reported last month.

Mike Scarcella is a senior editor in Washington on ALM's regulatory desk. Contact him at [email protected]. On Twitter: @MikeScarcella.

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