How Will Digital Therapeutics Be Evaluated by the P&T Committee?

We are addicted to our smart devices, but this may offer an opportunity to provide better access to care. They can be used as avenue for delivering safe and clinically effective therapy, particularly for more than 160 million Americans living with chronic diseases. During their virtual presentation at AMCP 2021, Snezana Mahon, PharmD, vice president and general manager at Care Solutions Evernorth, and Samir Mistry, PharmD, vice president of pharmacy at PreferredOne, discussed how digital therapeutics (DTx) can benefit patients and entire health care teams, and managed care approaches to coverage of DTx. 

Chronic diseases, the nation’s leading cause of death and disability, and the leading driver of $3.3 trillion in annual health care costs, affect 6 in 10 adults in the United States. Four in 10 of them have two or more chronic diseases. Drs. Mahon and Mistry believe that effective DTx can help improve overall patient experience and outcomes.

Recent technological changes have altered the overall market landscape; about 300,000 digital health solutions are currently available, with more than 200 introduced daily. A multitude of digital health solutions span health topics such as fitness/wellness, chronic condition prevention, mobile health applications, and more. The presenters said that traditional medications are now (and will be increasingly enhanced by) digital technologies. Digital therapeutics are essentially software programs that leverage cognitive behavioral therapy (and which may be accessible by prescription only), providing on-demand care and education.

In addition to DTx, the broader digital health landscape features other categories, such as mobile health; health information technology; telehealth; personalized health care; devices, sensors, and wearables; and others. Whereas DTx is a distinct subset in this environment, it can seamlessly integrate with all other categories.

The presenters also discussed the vital question for health plans an insurer of how to evaluate DTx for coverage decision-making. They suggested leveraging a standardized intake and evaluation process, similar in many ways to conventional pharmaceutical evaluations. For DTx, this would also review outcome studies (and methodologies) available on clinical effectiveness and patient experience, how it engages the plan member, and its security/privacy certifications. Economic value assessments of DTx, they said, are also possible, including cost offsets.

Another thorny question is whether the DTx will be covered by the pharmacy or the medical benefit. This depends, they said, on whether the DTx is something a patient can use independently, or whether it requires a specialist/provider consultation.

While some questions remain, the presenters felt that overall, a DTx provides a better patient experience.

Mahon S, Mistry S. Digital Therapeutics Formulary: Value of Applying Traditional Management Tools. Presentation F13. Presented at AMCP 2021; April 12-16, 2021.