Role of Prescription Digital Therapeutics in Mental Health Care

Lisa Marsch, PhD: Hi, my name is Lisa Marsch. I'm a professor of psychiatry and biomedical data science at Dartmouth College and the director of the Center for Technology and Behavioral Health at Dartmouth College. Digital therapeutics refers to software that delivers a clinical-grade intervention to prevent, manage, or treat a disease, and within that broader umbrella category of digital therapeutics is something called prescription digital therapeutics. Prescription digital therapeutics is software that clinicians can prescribe in the US. This refers to software that has gone through review at the US Food and Drug Administration and has very clear data from clinical trials showing that it is safe and effective in preventing, managing, or treating a disease or disorder. It requires this FDA clearance in order to be distributed and then prescribed by clinicians in this country, and it requires oversight by health care providers for implementation.  

This slide shows a list of the prescription digital therapeutics that are available right now in the US for the treatment of mental health. As you can see, the very first prescription digital therapeutic that was FDA-authorized in the US was in 2017, and it was specifically for the treatment of substance use disorders. Then, a year later, we saw a new indication for a prescription digital therapeutic for the treatment of opioid use disorder to be used in combination with medication treatment for opioid use disorder.  

Now, we have a growing array of prescription digital therapeutics available for many different mental health conditions, including PTSD, ADHD, insomnia, panic disorder, attention deficit, and, very recently, major depressive disorder and anxiety disorder, and just very recently for, postpartum depression. Many applications are available right now for mental health in the US.

Prescription digital therapeutics have very specific attributes that make them incredibly appealing as resources that clinicians can use in providing care to their patients. First of all, it requires provider oversight—it's prescribable. Clinicians prescribe this to their patients, and this can be prescribed as a standalone treatment or can be used with a whole array of different treatment models, including other types of mental health care, behavioral therapy, and or medication treatment. It requires this regulatory review. There are very specific criteria that you have to achieve in order to get this FDA regulatory clearance showing safety and clinical effectiveness in order to make a claim that this software is effective in preventing, treating, or managing a health condition. They are developed under Good Manufacturing Practices, so they have very strong quality management and are critical and recognized by the World Health Organization. Finally, getting prescription digital therapeutics status increases eligibility for reimbursement and payer coverage by a whole array of different payers, including health insurance companies and other regional health care systems. If you'd like any more information about prescription digital therapeutics, you can go to Psych Congress Network.