This session was developed by Pear Therapeutics and is NOT accredited for continuing pharmamcy education credit.
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.
- Discuss the criteria payers have used to review and evaluate PDTs for coverage.
- Discuss the physician’s perspective on PDTs.
- Identify contracting approaches for PDTs.
Jeff Berkowitz, JD
Pat Gleason, PharmD
Assistant Vice President
Yuri Maricich, MD
Chief Medical Officer
Arwen Podesta, MD
New Orleans, LA
John Fox, MD, MHA
Foxworthy Healthcare Consulting
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