There is a lot of activity happening in digital therapeutics right now. Happify recently announced Ensemble, the first and only transdiagnostic prescription digital therapeutic for the treatment of patients who have Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD). Pear Therapeutics went public through a $1.6B SPAC deal. Freespira's FDA cleared digital therapeutic is the first to significantly reduce or eliminate symptoms of panic attacks, panic disorder, and PTSD. Woebot announced a $90M series B funding round.

At the Going Digital: Behavioral Health Tech conference, I sat down with Dr. Chris Wasden, Head of HappifyDTx, to discuss the rise of the digital therapy platform for the mental health pandemic and how Happify is supporting health plans, pharma and employers with their suite of digital therapeutics. I caught up with him again to learn about their latest announcement, the launch of their Ensemble digital therapeutic:

If I'm a patient receiving an Ensemble prescription for the first time, what will my experience look like? 

Wasden: You will be guided through 112 therapeutic interventions over the course of 10 weeks, with 2 activities to complete each day which consist of CBT, mindfulness and positive psychology based interventions (aka activities). Every two weeks you will complete both the PHQ-9 and GAD-7. All your data is collected and shared with your clinician to support you in your treatment journey. We would expect you to spend 15-30 per day on these activities. 

Why should payers and employers pay attention to digital therapeutics for mental health? Why are they better than today's alternatives? 

Wasden: Payers, and providers, are aligned with the Triple Aim of healthcare: affordable care with greater access and high quality. DTx products like Ensemble improve a payer’s ability to deliver on the Triple Aim.  Most patients must wait weeks or months to get an appointment for mental health disorders, with Ensemble, the patient can start treatment immediately while they wait to see a physician or therapist. Clinical trials and studies have demonstrated that these products are safe and effective at treating these disorders. We estimate that using a DTx product like Ensemble improve the physician and therapists management of the patient, but having the patient spend 10 hours on therapy on their own time for every hour they spend with the healthcare professional, thus allowing the healthcare profession to spend more time with the patient on specific healthcare activities that are of high value and can only be done through face-to-face interaction. 

One concern some people have about digital therapeutics is that if individuals need a prescription to access them, will  that make mental health support less accessible than if they were like many of the other online CBT tools that are freely available online.

The reality is that there are thousands of online CBT apps and tools available online, and most are not efficacious. The majority of commercially available apps make claims related to mental health that they cannot back up with scientific evidence, per Dr. John Torous and his team at the Division of Digital Psychiatry at Beth Israel Deaconess Medical Center. Those apps must go through the very rigorous process of FDA approval if they want to claim to actually treat a patient with a specific diagnosed disease with a digital therapy. If those solutions aim to achieve the FDA approval, they must be a prescription therapy per FDA guidelines. 

Be sure to watch my robust #GDBHT2021 conversation with Dr. Wasden here, where we covered everything from creating “value beyond the pill” for Pharma companies, FDA changes, business models for digital therapeutics, point solutions vs platforms, and here the future of digital therapeutics is going.