Big Health, a maker of digital treatments for mental health, has clinched Food & Drug Administration (FDA) clearance of its product for insomnia, Fierce Healthcare has learned in an advanced look.
SleepioRx, its flagship digital therapeutic, is intended for the treatment of chronic insomnia and insomnia disorder as an adjunct to usual care in adults over 18. Sleepio can now be used as a prescription device by providers around the country.
The digital therapeutic version is based on Big Health’s existing offering, Sleepio, and delivers self-directed cognitive behavioral therapy. It is intended as a 90-day treatment, depending on a person’s severity. SleepioRx is designed for a provider to initially onboard and educate a patient about the product and periodically check in to see how the treatment is working.
“It delivers evidence-based techniques that target the cognitive and behavioral factors that maintain chronic insomnia and sleep problems,” Big Health CEO Yael Berman told Fierce Healthcare.
Sleepio has existed for more than a decade through employer, payer and international health system partnerships. Big Health will continue to offer both products, as well as its broader suite of programs.
About a quarter of U.S. adults suffer from insomnia each year and cost the industry $62.3 billion annually in lost productivity, according to one 2011 estimate. Poor sleep is associated with increased risk for a number of health conditions, including diabetes, obesity, heart disease and cancer. Those who lack sufficient sleep are also at higher risk of stroke and dementia.
Today, most options available to providers to treat insomnia are medication or long waiting lists for therapy, according to Berman. “This enables providers to be able to prescribe this treatment for the first time,” she noted. Sleepio doesn’t need human intervention—“that’s the magic of it”—and by not needing therapists, the product is more easily scalable, Berman added.
Big Health’s mission is to help people have good mental health with a non-drug approach to mental healthcare. “We want to be available at that point of care and treated in the same way that some of these medications are treated,” Berman said. Its programs lean on gold-standard behavioral techniques, the company says, and are backed by more than 90 research publications.
The SleepioRx clearance comes not long after the proposed 2025 Medicare Physician Fee Schedule, which includes a proposal to pay for FDA-cleared digital mental health treatments. Big Health is hopeful this will establish a promising pathway to scale access to SleepioRx and other digital therapeutics.
The rule is expected to be finalized in November, per Berman, and would go into effect at the start of 2025. It would open up access for all Medicare beneficiaries to be prescribed a digital therapeutic and if finalized as is, would be subject to regular cost-share requirements. That means Medicare could pay for the bulk of the product, Berman said. Big Health will also work with health systems to figure out the best way to keep its product affordable “cause we know that can be a huge barrier to care and we want to make sure it’s equitable for everyone...we don’t want cost to get in the way,” Berman said.
Pursuing an FDA clearance is “not for the faintest of heart,” Berman said, but it's been the company’s long-term goal. Executives hope the clearance opens a new distribution channel and makes Sleepio available where people seek care the most — through their providers. Prior to this, Big Health also made Sleepio available to a few large U.S. health system partners, including Henry Ford Health System. Berman declined to share the names of the other health system partners.
Sleepio has also been approved by the U.K. regulatory body NICE and it has been available for all Scottish adults for years. Now, U.S. providers will have the opportunity to get reimbursed for it.
While Berman is hopeful that commercial payers will follow Medicare’s lead, they set their own rates and go by their own timing. She anticipates there will be a learning curve for payers who need to get comfortable with this new billing code and category of care, though she stressed that Sleepio is not new and is backed by years of evidence.
“There have been some significant changes that have gone on in the digital therapeutics space and I hope that this is the industry turning a corner,” Berman said.
SleepioRx has been evaluated in more than 25 clinical trials. Up to 76% of patients achieve healthy sleep and continue to experience improvements in sleep up to three years after using SleepioRx. The product has also demonstrated effectiveness in racially and socioeconomically diverse samples through longitudinal research in partnership with Henry Ford Health System per Berman.