Devices & Diagnostics, BioPharma

FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers.

A software app that modifies behavior through a series of lessons and exercises has received FDA clearance for treating patients with major depressive disorder, making it the first prescription digital therapeutic for this indication.

The product, known as CT-152 during its development by partners Otsuka Pharmaceutical and Click Therapeutics, will be commercialized under the brand name Rejoyn.

Rejoyn is an alternative way to offer cognitive behavioral therapy, a type of talk therapy in which a patient works with a clinician in a series of in-person sessions. In Rejoyn, the cognitive behavioral therapy lessons, exercises, and reminders are digitized. The treatment is intended for use three times weekly for six weeks, though lessons may be revisited for an additional four weeks. The app was initially developed by Click Therapeutics, a startup that develops apps that use exercises and tasks to retrain and rewire the brain. In 2019, Otsuka and Click announced a collaboration in which the Japanese pharma company would fully fund development of the depression app.

presented by

Rejoyn does not replace drug therapy. The FDA decision covers the use of the digital therapeutic as an adjunct to antidepressant medication, which is how it was evaluated in a clinical trial. The antidepressant medications were not specified, though Otsuka’s portfolio has two of them: Abilify and Rexulti. The study enrolled 386 adults between the ages of 22 and 64 who were randomly assigned to use Rejoyn or a sham app for six weeks. The sham app included exercises but did not offer the cognitive behavioral therapy lessons or exercises such as those that are in Rejoyn.

The main goal of the clinical trial was to measure the change in score (a higher score indicates worsening symptoms) according to a rating scale used to assess the severity of depressive episodes. According to a briefing document that Otsuka is providing to prescribers, the clinical trial results showed the average change in total score in the Rejoyn group was -9.03. However, that decrease in score was not statistically significant compared to the -7.25 score change in the sham group. In a four-week extension period, Otsuka said the effects from treatment showed “a trend favoring continued improvement.” No adverse events were reported from the clinical trial.

Statistical significance is not absolutely necessary for 510(k) clearance, a pathway that requires a medical device to demonstrate it is substantially equivalent to another device legally marketed in the U.S. “Substantial equivalence” means the new product has the same intended use as the predicate device and is as safe and effective as that predicate device. In an email announcing the FDA clearance of Rejoyn, Click Chairman and CEO David Klein said the clinical trial, named MIRAI, and the FDA clearance are examples of how digital therapeutics are positioned to help define the future of clinical care.

“The MIRAI study validated Rejoyn’s novel treatment approach and was central to the FDA filing,” he said. “It is one of the largest studies completed to date on a digital therapeutic and one of the very few to evaluate a digital therapeutic’s effectiveness in a blinded comparison to a sham app that was designed to match the treatment in time, attention, and participant expectation of therapeutic effect.”

The 510(k) pathway is the same one taken by Pear Therapeutics, which received clearances for apps developed for treating substance use disorder, opioid use disorder, and insomnia. A cognitive behavioral therapy app developed by Better Therapeutics for type 2 diabetes was authorized last year through the FDA’s De Novo pathway for devices that do not have a substantially equivalent predicate device.

Despite passing regulatory muster, the apps from both Pear and Better failed to secure reimbursement from enough payers to make the products commercially viable. Pear sold its assets as part of bankruptcy proceedings last year. Unlike Pear, Better had taken its app all the way through Phase 3 testing, generating clinical data that executives said would be important for winning insurance coverage of the new technology. But Better ran out of time and money. In its third quarter 2023 financial report, Better said its cash reserves would last only through the first quarter of 2024. Within that time frame, the company expected to announce the first coverage decisions for its digital therapeutic. Those announcements never came. Two weeks ago, Better laid off its entire staff and said it would explore strategic alternatives, including the potential wind down of the company.

Rejoyn will also need to show it can secure payer coverage. But unlike the digital therapeutics from Pear and Better, Rejoyn has the backing of a large company that already has a market presence in the indication cleared for the product. In an email, Otsuka spokeswoman Jill Roman said the company expects Rejoyn will become available for download from iOS and Android app stores this summer. Licensed prescribers will send prescriptions electronically to the pharmacy. Upon payment, the pharmacy will send the patient an access code that unlocks the treatment. Roman said Otsuka is unable to discuss pricing of the therapy at this time.

Photo: LDProd, Getty Images