Rejoyn: First App Cleared by FDA for Depression; Cost, Efficacy Unclear

Rejoyn joins only a handful of digital therapeutics that have been cleared by the FDA, and that should account for something, noted Dror Ben-Zeev, Ph.D., a psychologist and professor of psychiatry and behavioral sciences at the University of Washington.

Clinicians advocated for the creation of a regulatory framework to enhance patient safety and provide insight into efficacy of digital mental health tools, to help tame the “wild west” of thousands of digital offerings, pointed out Ben-Zeev, who is also the editor for the Technology in Mental Health section of Psychiatric Services.

“I don’t know if we want to look through the weeds of cleared apps and say ‘Well, it’s promising, but not promising enough,’” Ben-Zeev said. “We are in the midst of such a mental health crisis that digital interventions that prove to be safe and demonstrate clinical usefulness for at least some people should certainly be considered.”

Depression is one of the most common mental illnesses, with about 21 million U.S. adults experiencing major depressive episodes in the past year, according to the National Institute of Mental Health. Yet nearly two-thirds don’t seek professional help, mostly due to stigma and cost. At least one third of those treated still experience significant residual symptoms.

However, FDA clearance has not necessarily guaranteed previous apps a path to coverage by insurance.

Pear Therapeutics Inc. secured clearance for its reSET line of CBT-based apps for substance use disorders but declared bankruptcy in 2023 after payors refused to cover them. It is unclear how many insurers cover the FDA-authorized video game EndeavorRx, designed to improve the attention span of children with ADHD. Creator Akili Interactive Labs Inc. now markets a less expensive “over the counter” version for adults.

NightWare was cleared by the FDA in 2020 for its ability to detect and gently interrupt patients’ recurring nightmares, but not their sleep. Yet it has not secured coverage by Medicare or private insurance companies, according to the company’s website. It is offered through the Department of Defense and the Veteran’s Administration.

Torous said it remains to be seen whether insurance will cover Rejoyn, given the results. “Or if not, will people want to pay for it? What price point will manufacturers’ set?” At least one major insurer, UnitedHealth Care, wrote last year that its pharmacy benefit manager OptumRx would deny claims for all FDA-approved digital apps, effective September 2023.

“Rejoyn adds to the landscape of potential treatments for depression. There are very few digital therapeutics with an evidence-based intervention,” said Kunmi Sobowale, M.D., an assistant professor of child and adolescent psychiatry at UCLA Health with a special interest in digital technology for the prevention and intervention of mental illness. “Whether it improves the quality of care remains to be seen based on the study results. … However, I don’t think [the Rejoyn app] really moves the needle in terms of improving access or decreasing the cost of care, since it still requires a physician to prescribe it. Only some patients will be able to afford it. ■