Prescription Digital Therapeutics: Regulatory Approval Pathway and Outcomes Evidence
This activity was supported by an independent educational grant from Pear Therapeutics, Inc.
The digital therapeutics market is rapidly growing, with thousands of digital therapeutics products now available. With this rise brings the need for health plans to develop formulary strategies and coverage determinations for these products, and importantly the ability to distinguish prescription digital therapeutics (PDTs) and non-prescription therapeutics.
The FDA review and authorization process for PDTs is similar in some respects to the approval process for prescription drugs, yet there are evidentiary and technology assessment differences due to the different statutory and regulatory standards for medical devices (including PDTs) and drugs. Understanding the extent of clinical trial design, data collection, and post-marketing surveillance can assist in the evaluation of digital therapeutics, particularly FDA-cleared or authorized PDTs compared to unapproved products (including wellness apps and other digital health products).
Since the first FDA-authorized digital therapeutic in 2017, at least nine prescription digital therapeutic products have gained FDA authorization or clearance for a variety of clinical indications. Payers now have FDA review and authorization information when making formulary decisions and need to understand how best to use this data and accompanying evidence for inclusion in coverage decisions.
Don’t miss your opportunity to learn more about the regulatory review and authorization pathways, outcomes evidence, and formulary considerations for PDTs!
At the completion of this activity, participants should be able to:
Differentiate prescription digital therapeutics (PDTs) from non-prescription therapeutics in terms of definition and key characteristics.
List at least 3 of the FDA-approved prescription digital therapeutics products and their indication for use.
Describe the Food and Drug Administration premarket pathways for prescription digital therapeutics.
Describe the efficacy and safety evidence from clinical trial data necessary for FDA prescription digital therapeutics.
Discuss managed care approaches to evaluate prescription digital therapeutics for coverage decisions.
This knowledge-based activity has been designed to meet the educational needs of pharmacists in managed care settings.
Pat Gleason, PharmD
Assistant Vice President
Digital Therapeutics Alliance
Allyson B. Mullen, JD
Hyman, Phelps & McNamara P.C.
Washington, District of Columbia
Drake J. Reiter, PharmD, RPh
Executive Fellow in Healthcare Association Leadership
The Academy of Managed Care Pharmacy (AMCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
ACPE UAN:0233-0000-22-028-H01-P • Activity Type: Knowledge-Based
Contact Hours: 1.25
Release Date: May 12, 2022 • Expiration Date: December 31, 2023
Activity Fee: Free for Members and Non-Members
Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at AMCP 2022. CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.
To receive credit for an online activity you must:
- Review the full content of the activity.
- Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
- Complete a specific activity evaluation.
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.
|Activity Number||Credit Amount||Accreditation Period|
|ACPE UAN #0233-0000-22-028-H01-P||1.25 Contact Hours||May 12, 2022 - December 31, 2023|