In June, AMCP hosted the Deep Dive into Prescription Digital Therapeutics Summit, convening expert panelists and attendees from across the industry. Of those registered for the event, the majority were from payer organizations. When exploring the type of benefit coverage model managed care organizations are using for digital therapeutics, pharmacy benefits ranked as the most reported coverage type. Although organizations are currently utilizing a variety of benefits and programs to integrate digital therapeutics — medical, wellness, digital health, and others — coverage is not ubiquitous.
Attendees were eager to learn more about PDTs, ranking formulary evaluation tools and resources, and coverage designs as the top areas of interest for additional information and guidance. Most (86%) agree that “filling gaps in care” not met by traditional office visits and pharmaceuticals is critical to improving outcomes in many chronic illnesses. More than half (52%) of attendees responded that reimbursement methodology and coverage by government entities is the top priority in the adoption of PDTs. A consistent framework for the evaluation of PDTs and real-world outcomes were additional barriers attendees indicated efforts are necessary.
At the conclusion of the Summit’s engaging conversations, intriguing questions, and call to action momentum, these are 10 key takeaway points:
1. PDTs are regulated medical devices requiring robust clinical and software testing before FDA clearance or approval.
2. PDTs are a distinctive and relevant category of digital health technologies that can fit very well into the pharmacy benefit in terms of management and utilization.
3. Payers and manufacturers, each with unique definitions of the value of PDTs for a specific population, must collaborate to align standards for evaluating PDTs.
4. Payers need to think outside of the typical drug evaluation process for PDTs. This may require coordination with a variety of experts to incorporate the unique PDT components.
5. Gaps in care exist. Operationalizing novel PDT treatment modalities require many stakeholders' pioneering to establish scalable access and reimbursement mechanisms.
6. Policy is one key factor impacting PDT adoption, coverage, and payment. The Access to Prescription Digital Therapeutics Act of 2023 has the potential to define Medicare coverage and benefit determination from which commercial organizations may establish reimbursement.
7. For PDT innovations to meet the medically necessary level, it is crucial to invest in standing up the evidence, systems, and infrastructure to integrate PDTs into the standard of care.
8. Data mapping is the foundation of privacy compliance.
9. Although the knowledge and infrastructure exist for collecting meaningful PDT data, there is a need to optimize and think differently about how the data is used to create meaningful change.
10. PDTs offer viable solutions, and although they may look different from traditional prescriptions, equitable access to these valuable treatment options requires managed care commitment to creating a path forward.
The recordings from AMCP’s live event are posted on AMCP Learn and are free to members. AMCP’s Digital Advisory Group will release several helpful industry tools on PDTs later this year. Look for additional information on prescription digital therapeutics on AMCP’s newly updated Digital Therapeutics Resource Center.
References:
1. Access to Prescription Digital Therapeutics Act of 2023 (S.723/H.R. 1458), 118th Congress (2023-2024). Accessed June 16, 2023 at https://www.congress.gov/bill/118th-congress/senate-bill/723 and https://www.congress.gov/bill/118th-congress/house-bill/1458.
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