Digital Therapeutics: The Basics
Digital therapeutics are a new area of healthcare, but growing quickly. A digital therapeutic is a software program, typically an app, that uses evidence-based behavioral change techniques like Cognitive Behavior Therapy and can be used on a daily basis. Frequently a digital therapeutic is used in conjunction with other medical interventions including therapy and pharmaceutical medications.
The first prescription digital therapeutic to clear the FDA was an app from Pear Therapeutics for addiction, back in 2017.
One top resource for all things DTx is the non-profit Digital Therapeutic Alliance (DTA). They were formed in 2017 to grow alongside the industry and help educate all healthcare stakeholders on digital therapeutics, including patients, payers, policymakers, clinicians, corporations, startups, and other stakeholders.
DTA defines Digital Therapeutics as:
“Evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease”
PDT vs. DTx
There are 2 abbreviations that are commonly used to describe digital therapeutics, PDT and DTx. PDT specifically means prescription digital therapeutic, and DTx can describe both a prescription digital therapeutic and a direct-to-consumer digital therapeutic.
About CBT
Many of the digital therapeutic apps use Cognitive Behavior Therapy, frequently referred to as CBT.
CBT is the most widely used, evidence-based, and broadly applicable technique in behavioral health. It is based on the belief that emotions, reactions, physical sensations (i.e. pain), and actions are all connected. Teaching the patient or user different, more positive ways to think or behave can help counteract the negative issue in need of treatment (i.e., insomnia or depression). CBT can be an effective treatment for many behavioral health issues including depression, anxiety, addiction, interpersonal relationships (i.e., marital problems) and even some forms of severe mental illness.
There are many different forms or techniques of CBT including Exposure Therapy; Systematic Desensitization; Diaphragmatic Breathing; Muscle Relaxation; Visualization/Imagery; Contextual Therapies; Mindfulness; Attentional Training; EMDR; and Psychoeducation.
Reimbursement
As of April of 2022, Medicare’s new CPT codes for CBT based digital therapeutics became active. The new CPT code does cover the Pear Therapeutics FDA cleared apps.
Check out the DTA statement here.
Examples of Digital Therapeutics
President & CEO Cory McCann
A main leader in Digital Therapeutics (DTx) is Pear Therapeutics. As mentioned above, Pear had the country’s first digital therapeutic available by prescription only and cleared by the FDA.
Pear now has three FDA cleared prescription apps on the market for medical problems like insomnia and addiction — conditions with a large behavioral health component. Pear’s digital therapeutic apps use CBT — Cognitive Behavior Therapy. CBT is a gold standard that mental and behavioral health experts use for conditions with a behavioral component including depression, like addiction, and insomnia.
Pear Therapeutics Pipeline:
Click Therapeutics
Co-founder & CEO David Benshoof Klein
Click Therapeutics has over $900M in funding, including their latest round of debt financing and some multi-year milestone-based funding. Japan-based Otsuka Pharma is one of the main milestone-based funders with $300M specifically for Click to develop a digital therapeutic app for Major Depressive Disorder, a condition they already treat. Germany-based pharma Boehringer Ingelheim is also a milestone-based funder with $500M to develop a digital therapeutic app for schizophrenia, a condition they cover. While the details of these deals aren’t public, Click likely traded significantly less stock for that $800M of milestone-based funding than if they had done a straight $800M VC round.
Click has FDA clearance for a smoking cessation app, and a pipeline of future DTx apps for migraine, overactive bladder, obesity, chronic low back pain, and acute coronary syndrome in various stages of development, trials, FDA clearance, and launch.
In the deals with the BigPharma companies, these future DTx prescription apps would work in conjunction with pharmaceuticals and/or healthcare professionals such as therapists, psychologists, and psychiatrists. These partnerships also provide a channel for the pharmaceutical company to understand exactly how their medication is working on a day-to-day basis.
Akili Interactive Labs
Co-founded by Eddie Martucci and Adam Gazzaley
Unlike the other companies in this article, EndeavorRX is an actual video game.
EndeavorRx® is a prescription treatment delivered through a video game for ADHD. They have cleared the FDA with emergency use authorization for children between the ages of 8 and 12 years old. EndeavorRx is a tool to be used in conjunction with therapy, education, and/or medications, and is available by prescription only. It is not a replacement, but and enhancement.
EndeavorRx is covered by many of the payers in the U.S.
The Akili team approached ADHD from a game mechanics standpoint. They realized that by making a treatment fun, that could lead to engagement and better compliance. This is especially true with children. Akili created a video game that can be used for half an hour a day that helps improve the child’s ability to focus while ignoring distractions. The software automatically locks after 30 minutes so no one is able to continue to play after the treatment is completed each day.
Akili Interactive Labs went public through a SPAC in August of 2022.
Twill Health
Co-founders Ofer Leidner & Tomer Ben-Kik
Twill Health has digital solutions for over 10 chronic conditions in 190 countries and 10 languages. Similar to Click Therapeutics, Twill partners with global pharmaceutical companies to create disease specific digital solutions. They are also partnered with Cigna and the American Heart Association.
Their latest solution is a Digital Therapeutics app called Ensemble to treat the symptoms of Generalized Anxiety Disorder (GAD) and Major Depression Disorder (MDD). In conjunction with therapy and/or medication, the 15-minute app-based exercises are led by an AI chatbot coach named Anna and completed once or twice a day. The app-based exercises work with the user to change negative thought patterns into more productive habits by focusing their attention on positive thoughts or goals, and then tracks their progress over a 10-week program. Like many of the other digital therapeutics, these new positive thought patterns aren’t just to help anxiety or depression today, they are meant to become life-long habits to help anxiety and depression long after the user stops interacting with Twill Health.
Check out some of the other startups on the DemocratizingHealthcare.ai book website by Michael Ferro & Robin Farmanfarmaian.
