Digital Therapeutics

PDTs are evidence-based treatments that use software or virtual tools, and sometimes hardware, to deliver a clinical benefit to patients. They have many known uses, helping Americans identify, treat, and manage illnesses across a wide range of conditions, including post-traumatic stress disorder (PTSD), diabetes management, substance and opioid use disorder, attention-deficit hyperactivity disorder (ADHD), chronic back pain, decreasing eyesight, and more. PDTs are subject to review and authorization by the Food & Drug Administration (FDA) and must be prescribed by a health care provider.

Prescription digital therapeutics (PDTs) are software-based therapies shown to benefit those with mental health conditions like depression. However, many PDTs do not currently fit into one of the statutorily defined coverage categories for the Medicare or Medicaid programs, leaving beneficiaries of those programs—which include some of America’s most vulnerable populations—without access to these effective and accessible treatments. AMCP supports the Access to Prescription Digital Therapeutics Act, an important bipartisan bill that would help remedy this disparity by creating a comprehensive benefit category and expanding Medicare coverage to include PDTs.

Prescription Digital Therapeutics (PDTs) offer vast opportunities but require careful consideration for coverage and reimbursement. At the direction of the AMCP Board of Directors we have developed definitions and principles to simplify your decision-making and provide digital health innovators with essential insights for evaluating safety and efficacy.

Prescription digital therapeutics (PDTs) are health software, available by prescription only, intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.

PDTs offer significant promise in treating certain conditions and improving access to care, but participants agreed that a new modality requires new approaches to coverage. This brief is intended to help prepare the American health care system to begin covering PDTs.

Host Fred Goldstein invites Jennifer Mathieu, Senior Vice President, Professional & Government Affairs to discuss the Prescription Digital Therapeutics Act, the Medicaid MVPs for Patient Act and other AMCP legislative priorities.

AMCP supports increased access to Prescription Digital Therapeutics (PDTs). PDTs are software-based therapies that deliver clinical benefits to patients, either alone or in combination with other forms of treatment. These therapeutics require a prescription and are subject to oversight by the Food and Drug Administration (FDA). To be approved by the FDA, PDTs must demonstrate both safety and efficacy.

Managed care pharmacy and prescription drug coverage is a growing part of the American health care sector. AMCP launched the annual Access, Affordability, and Outcomes report to raise awareness of the existence, prevalence, and importance of managed care pharmacy.

Health care expert Fred Goldstein, host of the AMCP Podcast Series — Listen Up! speaks with Dr. Scott Whittle from Meridian Solutions about the pathways to bringing app-based prescription digital therapeutic solutions to health care.

In June, AMCP hosted the Deep Dive into Prescription Digital Therapeutics Summit, convening expert panelists and attendees from across the industry. Read 10 key takeaway points from the Summit.

A rapidly evolving area of interest is digital therapeutics, evidence-based software interventions used to treat, manage, or as an adjunct treatment for various medical conditions. Here are three reasons why you should attend the Virtual AMCP Summit: Deep Dive into Prescription Digital Therapeutics.