AMCP Partnership Forum Develops Steps to Strengthen Evaluation of Digital Therapeutics

Last week, more than 40 experts representing payers, pharmacy benefit managers, integrated delivery systems, health economists and analysts, patient advocates, academicians, digital therapeutic innovators, and other key stakeholders in the managed care setting convened virtually for AMCP‘s Partnership Forum Digital Therapeutics: The Evolving Role of Digital Therapeutics. The purpose of the forum was to explore the current market space for digital therapeutics, including the evidence and benefits of the products, their place in treating disease, and challenges patients face in accessing therapies. The group also worked to identify challenges and payer needs related to the evidence required to ensure coverage of digital therapeutics.

Forum participants discussed the importance of regulatory guidance in defining and categorizing digital therapeutics, identified opportunities to highlight the expertise of pharmacists in determining the value of digital therapeutics in health care, and discussed gaps in education that need to be filled among a variety of stakeholders involved in prescribing, evaluating, and using digital therapeutics.

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After deliberating on the current marketplace challenges around digital therapeutics, the group discussed various key components to better support appropriate and evidence-based coverage decisions for digital therapeutics, including:

• The vital role Pharmacy and Therapeutics Committees, or equivalent bodies, has in the evaluation of digital therapeutic products.
• The expectation that clinical evidence of a digital therapeutic product will be reviewed in comparison to standards of care.
• The importance of approval or market authorization by a regulatory body to payers.
• The expectation that digital therapeutic innovators generate and publish evidence that demonstrates that their product improves quality of care.
• The necessity that coverage decisions for digital therapeutics are based on scientific evidence that demonstrates a product is appropriate and safe. As with traditional drug therapies and biologics, evidence of cost-effectiveness, to the extent that it is available, is also important to support payers’ coverage decisions.
• The understanding that digital therapeutic innovators collect, store, and process users’ data in a safe, fair, and lawful way.
• The need for communicating impactful product updates to payers, health care decision makers, and patients.

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“The growing field of digital therapeutics has the potential to improve the quality of care for millions of patients across the country through innovative and personalized technologies,” said AMCP CEO Susan Cantrell, RPh, CAE. “Last week, our forum participants discussed the challenges still facing this emerging field but highlighted the limitless impact that these therapies can have through clinical, social, economic, or behavioral benefits. The concepts that were reviewed during the forum will provide a great framework to standardize the coverage of digital therapeutics and pave the way forward for its continued growth and adoption.”

All findings and recommendations from the AMCP Partnership Forum Digital Therapeutics: The Evolving Role of Digital Therapeutics, will be published in an upcoming issue of Journal of Managed Care + Specialty Pharmacy. In addition, AMCP will host a webinar in 2022 reporting the findings and recommendations. The event was sponsored by Akili Interactive, Pear Therapeutics, Pfizer, PhRMA, Simon Kucher & Partners, Takeda, Theranica, and Woebot Health.

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