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Big Health is the leading provider of scalable, clinically validated, non-drug treatments for the most common mental health conditions. As detailed in this GDBHT2023 session, Big Health’s two products — Sleepio for insomnia and Daylight for generalized anxiety disorder — have been shown in more than 80 peer-reviewed papers to deliver improved clinical outcomes without serious side effects.

Right now, hundreds of millions of people around the world are stuck in an ongoing struggle with their mental health. They’re overwhelmed in their daily lives and underserved in their options for care. Big Health’s pioneering work in clinically proven digital therapeutics is on course to tackle the challenge of delivering effective care at scale to help millions back to good mental health. We sat down and talked with Big Health’s CEO Arun Gupta about the growing mental health epidemic and why the timing is so right for digital solutions that are scientifically developed and clinically proven.

What’s at the core of today’s mental health care challenges?

In the US and UK, more than 130 million adults suffer from insomnia, anxiety or both.1-6 And, the sad truth is that the current default approaches are just not working. Nearly 70% of anxiety and insomnia patients are treated with prescription drugs only.7 More than three quarters of so-called “rescue” prescriptions exceed the recommended duration of 30 days, despite concerns about abuse and physical dependence.7 Regrettably, less than 10% of those treated receive the widely recommended first-line treatment, cognitive behavioral therapy (CBT).7 This may well be the most glaring case within our medical system where the widespread, ongoing practice is so divergent from what’s indicated by the data and clinical guidelines. 

Some say that digital therapeutics (DTx) offer a promising path forward. How so?

Mental health is emerging as the first large-scale use case for digital therapeutics because: irst it encompasses a number of highly prevalent conditions such as insomnia, anxiety, depression, PTSD, and chronic pain that, taken together, impact one in three human beings; second, the preferred treatment option of therapy is generally unavailable, which leads to reliance on prescribed medications that show mixed results and carry significant side effect profiles; and third, through the pandemic it has risen to a top-three issue for employers, health systems, and governments to address more effectively. Adding to these factors and market dynamics are patient preferences, which indicate that 75% of individuals would prefer a non-drug treatment.8 

Not to be confused with the growing range of wellness apps, digital therapeutics are real medical treatments that are defined by a number of distinct characteristics:

They’re evidence based — Based on proven models of care, such as cognitive behavioral therapy (CBT)

  • They’ve been clinically validated — Outcomes have been extensively validated in both peer-reviewed research and real-world studies
  • They’re reimbursable — Typically covered by payors, and therefore operate with the approval of financing systems that define them as healthcare (versus discretionary consumer spending)
  • They’re inherently scalable — Driven largely by automation, and not dependent on a large-scale provider network
  • They’re often FDA regulated —Typically as a medical device
  • They’re practitioner driven — Usually recommended, authorized, and/or directly furnished by a healthcare practitioner

Learn more about the W.H.A.T criteria for evaluating digital therapeutics

As one of the earliest entrants into DTx, what advantages does Big Health bring to the fight for better mental health?

Big Health is leveraging its decade-long commitment to building clinical-grade digital treatments that are deeply science based and research validated. Underlying our products, Sleepio for insomnia and Daylight for generalized anxiety disorder, is an industry-leading body of peer-reviewed research and randomized controlled trials. Our guideline-recommended digital treatments have the most evidence in the industry, supported by more than 80 peer-reviewed publications and 14 randomized controlled trials. Our products are proven to drive significant clinical improvement with 71-76% of participants having been shown to achieve remission.9,10 Importantly, we do this while also enabling meaningful cost reduction of $6,400 annualized decrease in per patient spend.11

Based on our pioneering work in the category and the magnitude of the opportunity ahead, I was both humbled and energized last year when Peter, Colin, and Big Health’s leading investors, including Softbank, Octopus, Gilde, and Morningside Ventures, came together and asked me to lead the company’s scale-up as CEO. 

I firmly believe that evidence-based, research-validated, fully automated digital treatments can have a huge impact in addressing the mental health crisis by providing a clear pathway to meaningfully scale and accelerate access to guideline-recommended care.

What do you see driving Big Health’s momentum over the next 12-18 months?

Looking across all the evidence, it's clear that the world is moving in our direction. Big Health has already been approved for reimbursement by numerous employers, large prescription benefit managers (PBMs), the National Health Service (NHS) in Scotland, and multiple payers. We concluded 2022 as the most successful year since our founding, achieving significant business milestones including: Series C Funding round for $75 million with SoftBank; Daylight and Sleepio products added to a second national digital formulary; National Institute for Health and Care Excellence (NICE) approval of Sleepio as first-line treatment for insomnia ahead of medication; development of a strategic partnership with a major payer for medication-based targeting; and enrolling our 300,000th patient in treatment. 

The time is right and our momentum is strong as we drive forward in 2023. We continue to build out a diverse and talented team with a number of recently named senior executives focused on finance, product, people, sales, and marketing, joining many long-standing Big Health employees who are experts in digital treatment development. We’re already on pace to add more covered lives this year than any in recent years, including several new strategic relationships. And our industry as a whole is maturing to understand the role that evidence-based digital treatments will play as the first-line mental health treatment of any modern health system. We look forward to sharing further progress and inviting more collaboration on the road ahead.

We’d love to hear from you. Contact us to learn how you can unlock coverage to clinically validated digital treatments for your population.

Article written by Arun Gupta, CEO of Big Health.

  1. United States Census Bureau 2020-2021 
  2. United Kingdom Census 2021, Office of National Statistics 
  3. NICE clinical guideline 22 (2004): ‘Anxiety: management of generalised anxiety disorder and panic disorder’
  4. Vargas et al., 2020. Brain Sciences
  5. Roth et al., 2011. Biological Psychiatry
  6. National Institute of Mental Health (2023). Any Anxiety Disorder.
  7. C Bazell et al. (pending publication) Treatment patterns for generalized anxiety disorder and insomnia in Medicare fee-for-service
  8. McHugh RK et al. (2013) Journal of Clinical Psychiatry
  9. Espie et al. (2012). Online cognitive behavioral therapy for chronic insomnia disorder.
  10. Carl et al. (2020). Depression & Anxiety. 
  11. Anderson et al 2014 (