Big Health is making mental health care more accessible through digital therapeutics.
The company developed a range of apps offering non-drug treatments for common conditions such as insomnia, anxiety and depression.
Big Health chose to not just stop there but also put the apps through the Food and Drug Administration clearance process with the hopes of integrating more digital therapeutics into clinical practice.
“A lot of people said we were doing the wrong thing,” Executive Chairman Arun Gupta said in front of an audience of nearly 300 people.
The company received validation for its decision when Gupta was honored at the Business Journal’s Innovator of the Year Awards at the Irvine Marriott on Sept. 12.
Evidence-Based
Big Health worked with psychologists and therapists to develop self-guided cognitive behavioral therapy.
Cognitive behavioral therapy, also known as CBT, is a form of talk therapy that leads patients through exercises to identify negative thoughts and behavioral patterns.
“If we can’t get everybody to a therapist, the next best thing is getting them into a self-paced, evidence-based program that models that therapeutic relationship as best we can,” Gupta said.
The company built clinically tested applications to cater to specific mental health issues.
Its SleepioRx app, intended to treat insomnia, and DaylightRx app, for generalized anxiety disorders, both received FDA approval this year, making it so doctors can prescribe them as treatments to patients.
DaylightRx is the first and only FDA-cleared digital therapeutic for its respective condition, according to Gupta.
Both clinical trials, which had more than 300 participants each, reported an average remission rate of above 70% by the 12-to-16-week mark.
Last year, Big Health expanded its model to include support for teens through the acquisition of San Francisco-based Limbix. Limbix’s digital app SparkRx aims to treat teens with symptoms of depression.
App-based therapies offer more flexibility than traditional in-person therapy, Gupta said.
Patients can access treatment at any time whether it’s during their commute to work or right before bed without adhering to a therapist’s schedule.
Big Health said it strives to make mental health treatment accessible regardless of socioeconomic status.
One of its 80 published papers claims that Sleepio alone “was shown to lower health care costs by $1,667 per employee.”
Reimbursement Programs
FDA-cleared digital therapy tools such as Big Health’s apps may soon be covered by health insurance plans.
The Centers for Medicare & Medicaid Services (CMS) in July announced a proposal to reimburse physicians for costs relating to digital therapies “used in conjunction with ongoing behavioral health care treatment.” If approved, the policy will go into effect in January.
“Then you have a reimbursement and payment mechanism to put it into the healthcare system and make it very much a part of everyday medicine,” Gupta said.
Still, several media outlets reference the rise and fall of Boston-based Pear Therapeutics Inc. as an example of the difficulty of commercializing digital therapeutics without securing reimbursement from healthcare insurers.
Pear Therapeutics in 2017 received FDA clearance for its substance use disorder treatment app.
The company last April, however, filed for Chapter 11 bankruptcy with CEO and President Corey McCann suggesting that a lack of health insurance coverage played a role in the company’s inability to scale.
“We’ve shown that our products can improve clinical outcomes. We’ve shown that our products can save payors money. Most importantly, we’ve shown that our products can truly help patients and their clinicians.
But that isn’t enough. Payors have the ability to deny payment for therapies that are clinically necessary, effective and cost saving,” McCann wrote in a LinkedIn post.
Gupta said there’s a need to raise the standards of mental health care to the same level of traditional medical care.
“This is a new care form, so there’s a whole host of challenges that we’re now tackling to change that pathway,” Gupta said.
Company Inspiration
While the process from submission to clearance took six months, the entire journey has been “years in the making,” according to Gupta.
The idea for Big Health was born out of co-founder Peter Hames’ own struggle with insomnia. Having studied experimental psychology at Oxford University, he was already familiar with non-drug alternative treatments and used Dr. Colin Espie’s book on CBT to help treat his insomnia.
Inspired by the experience, he contacted Espie and the two co-founded Big Health in 2012.
Gupta, who first joined the board in 2019, was named CEO of Big Health in August 2022. While the company’s headquarters is in San Francisco, Gupta works out of an office in Newport Beach.
The company has raised $130 million to date with plans to raise more in light of receiving FDA clearance.
“I think this has really been our dream year of going big and breaking into everyday medical care with digital therapeutics leading the way as our frontline against the mental health epidemic,” Gupta said.
