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Medication Targeting: Unlocking the Potential of Digital Therapeutics

Through a new collaboration with CVS Health, we now provide digital therapeutics when people need them, providing guideline-recommended mental health care.

I founded Big Health based on my personal experience with insomnia, where I was prescribed sleeping pills without any other options. Unfortunately, my experience is not unique, and persists for millions of patients around the world. Due to the significant shortage of mental health practitioners, 82% of people with mental health conditions receive medications, mostly prescribed in primary care, without ever receiving the option of behavioral interventions like cognitive behavioral therapy (CBT). At Big Health, our mission is to help millions back to good mental health, and we are focused on expanding access to high quality mental health care for everyone in need.

Our new Medication Targeting℠ program, launched in collaboration with CVS Health, is another significant step in achieving our mission, and we are excited to share that the program is now available to all health plan sponsors using CVS Caremark, the pharmacy benefit management (PBM) business of CVS Health. Through the Medication Targeting program, all patients who fill a common mental health medication prescription are offered immediate access to Big Health’s digital therapeutics, Sleepio for insomnia and Daylight for anxiety, as an option alongside their medications.

The leading clinical guidelines, including the American College of Physicians (ACP), recommend CBT as the first-line treatment for insomnia. Big Health’s Medication Targeting program ensures that mental health patients can now access CBT – delivered via digital therapeutics – alongside medication for the first-time at a meaningful scale.  

When Big Health first partnered with CVS Health in 2019, we pioneered the ability to bill through the PBM, enabling employers and health plans to pay for our digital therapeutics via a drug claim, which is the same way they pay for medications. This model effectively created a new benefit category for payers by better aligning incentives while making contracting easier than ever before. More importantly, it demonstrated the power of using the PBM as a platform to reach patients in need. While we are incredibly proud of our progress making it easier for payers to adopt digital therapeutics, we knew that to truly fulfill our mission of helping millions back to good mental health, we had to harness the PBM to further ease patient adoption. The Medication Targeting program does just that.

Over the years, we have shown that digital therapeutics reflect many of the positive traits of medications. Just like it’s easy to manufacture more pills for people in need, as a pure software service, we can easily scale access to these digital therapeutics across populations. Through rigorous clinical evaluation, including 13 randomized controlled trials, Big Health has proven that our solutions are safe, effective, and deliver consistent outcomes across populations. Now, we are using those strengths to our advantage, delivering digital therapeutics alongside medications to ensure that patients have the right treatment option for them.

Years after I first walked out of my doctor’s office frustrated by the fact that I could only access sleeping pills for my insomnia, through our innovative work with CVS Health, we are now able to offer the exact kind of personalized treatment patients need in real time. I truly believe that the Medication Targeting program is a monumental moment, not just for Big Health, but for the entire digital therapeutics industry. By demonstrating how we can create partnerships that leverage data to deliver clinical-grade solutions to patients exactly when and where they need them, we are now able to truly unlock the potential of digital therapeutics.

In accordance with FDA’s current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, for patients aged 18 years and older, who are followed by and diagnosed with insomnia disorder or generalized anxiety disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for insomnia disorder or generalized anxiety disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.

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During the COVID-19 public health emergency, Sleepio and Daylight are being made available as treatments for insomnia disorder and generalized anxiety disorder (GAD), respectively, without a prescription. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia disorder and GAD, respectively.

1. Qaseem, A., Kansagara, D., Forciea, M. A., Cooke, M., & Denberg, T. D. (2016). Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 165(2), 125-133.2. Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., … & Spiegelhalder, K. (2017). European guideline for the diagnosis and treatment of insomnia. Journal of Sleep Research, 26(6), 675-700.3. Wilson, S., Anderson, K., Baldwin, D., Dijk, D. J., Espie, A., Espie, C., … & Sharpley, A. (2019). British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. Journal of Psychopharmacology, 33(8), 923-947.4. King’s Technology Evaluation Centre. (2017, November 9). Overview: Health app: SLEEPIO for adults with poor Sleep: Advice. NICE. https://www.nice.org.uk/advice/mib129.5. Espie, C. A., Kyle, S. D., Williams, C., Ong, J. C., Douglas, N. J., Hames, P., & Brown, J. S. (2012). A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep, 35(6), 769-781.6. Carl, J. R., Miller, C. B., Henry, A. L., Davis, M. L., Stott, R., Smits, J. A., … & Espie, C. A. (2020). Efficacy of digital cognitive behavioral therapy for moderate‐to‐severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depression and Anxiety, 37(12), 1168-1178.

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