Available Until 12/31/2023

AMCP Partner Session: Prescription Digital Therapeutics: Best Practices for Evaluating Coverage Making the Way for Innovation

This session was developed by Pear Therapeutics and is NOT accredited for continuing pharmamcy education credit.

Course Description:

Prescription Digital Therapeutics (PDTs) are required to demonstrate evidence of clinical effectiveness and patient safety through well-controlled clinical trials that are reviewed by a regulatory body, in order to be authorized for sale in interstate commerce — in the U.S., that is the Food and Drug Administration (FDA), which regulates PDTs as medical devices. The regulatory rigor governing this review process is the same as any other medical device.

PDTs have the potential to provide transformative care to patients and expand access to treatment at a time when access to care, particularly in mental health, is experiencing significant challenges. Leveraging technological advancements to address gaps in care using software can potentially provide safer and more effective (clinical, economic) methods to prevent, manage, and treat diseases across multiple therapeutic areas. In addition, PDTs permit access to more convenient and flexible modes of care.

Yet PDTs face challenges in coverage and reimbursement. Overcoming these challenges is needed in order to deliver valuable care to patients. While there is a need to standardize the review process and develop pragmatic approaches to contracting, the time is now to discuss how we can embrace these new therapeutics and optimize care delivery.

Learning Objectives:

At the completion of this activity, participants should be able to:
  1. Discuss the criteria payers have used to review and evaluate PDTs for coverage.
  2. Discuss the physician’s perspective on PDTs.
  3. Identify contracting approaches for PDTs.


Jeff Berkowitz, JD


Real Endpoints

Florham Park, NJ

Pat Gleason, PharmD

Assistant Vice President

Prime Therapeutics

Eagan, MN

Yuri Maricich, MD

Chief Medical Officer

Pear Therapeutics

Boston, MA

Arwen Podesta, MD


Podesta Wellness

New Orleans, LA


John Fox, MD, MHA


Foxworthy Healthcare Consulting

System Technical Requirements/Viewing Requirements:

System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities, you should have a basic comfort level using a computer and navigating websites. View the minimum technical and system requirements for continuing education online learning activities