AMCP is Helping to Define Digital Therapeutics for Coverage Decisions

AMCP has been at the forefront of health care innovation for over 30 years, and today we continue that proud tradition by taking a leadership position on the exciting, emerging field of digital therapeutics.

Digital therapeutics: What are they, and where do they fit into pharmacy and medical benefits?

Those fundamental questions served as a starting point for our recent Partnership Forum on the challenges and opportunities of ensuring patients are able to access these unique therapies, which many agree are on the frontier of medical science.

Questions addressed by forum attendees included: How digital therapeutics differ from existing digital products in the health care space? What role do digital therapeutics play in preventing a disorder or disease, optimizing medication use, or treating a disease or disorder? What evidentiary requirements are needed for payer coverage of digital therapeutics? And where do these products fit in pharmacy and medical benefits?

To answer these questions, we brought together some of the country’s top thought leaders from across the health care spectrum, including life science companies, payers, providers, employers, patients and government. After a day-and-a-half of vigorous discussion, the participants generally agreed on:

• Descriptions for digital therapeutic: To qualify, the product must be a “high-quality digital intervention, making a medical claim, that is driven by software programs to prevent, manage or treat a medical disorder or disease.” Digital therapeutics also “require approval and third-party validation of efficacy and safety claims” by a regulatory or equivalent national body, such as the Food and Drug Administration, or a recognized accreditation or health services organization.
• Coverage decision standards: Coverage by payers will first include a thorough examination of the safety, efficacy, and usability of a product, along with the therapy’s medical claim or function. Products intended to replace a pharmaceutical intervention, for example, may require more evidence for coverage than those intended to monitor a condition. 

The participants also discussed the need to collect real-world data on the therapies over time. While data collection is a strength of managed care pharmacy, digital therapeutics present a unique challenge in that updates to software and operating platforms will result in iterative changes to these products. Strategies for evaluating digital therapeutics in the real world must include ongoing assessments of the products as updates are implemented. Read more details in our executive summary.

After attending this forum, I’m convinced more than ever the future is here. Already, digital therapeutics are coming to market with indications to prevent, manage, and even treat conditions ranging from diabetes and asthma, to depression and substance use disorder. These devices are indeed on the frontier of health care.

We acknowledge that building systems to support coverage of these products may be daunting. But so was the challenge in the late 1980s of managing medications for hundreds of millions of Americans. AMCP was up to the task then and is up to the task today. Managed care pharmacy is in an ideal position to help ensure patients have access to digital therapeutics that improve the health and wellbeing of our patients.

NOTE: Findings and recommendations from this event will be published in an upcoming issue of AMCP’s Journal of Managed Care & Specialty Pharmacy. The September 2019 Partnership Forum on digital therapeutics was made possible by the generous support of sponsors: Akili Interactive, Boehringer Ingelheim, Genentech, Livongo, MedRhythms, Merck & Co., metaMe Health, MindSciences, Novo Nordisk, Otsuka Pharmaceutical, Pear Therapeutics, Precision for Value, Sandoz, Sanofi, Takeda, Teva Pharmaceutical Industries, and Xcenda.