Prescription Digital Therapeutics: Regulatory Approval Pathway and Outcomes Evidence

Pricing: Free for Members and Non-Members

This activity was supported by an independent educational grant from Pear Therapeutics, Inc.

Course Description

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! 

Target Audience

Pharmacists who practice in managed care settings.

Learning Objectives

At the completion of this activity, participants should be able to:

  1. At the completion of this activity, participants should be able to:

  2. Differentiate prescription digital therapeutics (PDTs) from non-prescription therapeutics in terms of definition and key characteristics.

  3. List at least 3 of the FDA-approved prescription digital therapeutics products and their indication for use.

  4. Describe the Food and Drug Administration premarket pathways for prescription digital therapeutics.

  5. Describe the efficacy and safety evidence from clinical trial data necessary for FDA prescription digital therapeutics. 

  6. Discuss managed care approaches to evaluate prescription digital therapeutics for coverage decisions.  

Course summary
Available credit: 
  • 1.25 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 1.25 Certificate of Completion
Course opens: 
05/21/2023
Course expires: 
12/31/2024
Cost:
$0.00

Faculty

Pat Gleason, PharmD 
Assistant Vice President 
Prime Therapeutics  
Eagan, Minnesota 

Andy Molnar 
CEO 
Digital Therapeutics Alliance 
Arlington, VA

Allyson B. Mullen, JD  
Director 
Hyman, Phelps & McNamara P.C. 
Washington, District of Columbia 

Moderator

Drake J. Reiter, PharmD, RPh
Executive Fellow in Healthcare Association Leadership
AMCP
Alexandria, Virginia


 

Financial Relationship Disclosures

Faculty/Reviewer/PlannerReported Relevant Financial Relationships
Pat Gleason, PharmD
Faculty		Employee: Prime Therapeutics.
Andy Molnar
Faculty		Disclosed no relevant financial relationships.
Allyson B. Mullen, JD
Faculty		Disclosed no relevant financial relationships.
Sam Sui, PharmD, RPh
Reviewer		Disclosed no relevant financial relationships.
Brittany V. Henry, PharmD, MBA
Planner		Disclosed no relevant financial relationships.
  • AMCP Staff have disclosed no relevant financial relationships.
  • If applicable, relevant financial relationships have been mitigated and documented.
  • Content has undergone a peer review to ensure content validity.

 

Accreditation:

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 eLearning Days 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.

Available Credit

  • 1.25 ACPE
    ACPE The Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
  • 1.25 Certificate of Completion

Price

Cost:
$0.00
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