Industry excitement surrounding the development of digital health platforms and applications is growing, as patients look for new ways to access healthcare during the COVID-19 pandemic. In April, the FDA relaxed its requirements for public use of some digital therapeutics during the pandemic, which led to new products rushing into the market almost overnight. However, large insurers have taken a more hesitant approach to coverage of new digital therapeutics, even in cases where products have received FDA clearance based on a traditional clinical trial process and evidence development.
Digital Therapeutics Have Arrived But Will Insurers Get On Board?
Will FDA-cleared prescription digital therapeutics be able to follow wellness, chronic disease and sleep disorder apps onto the formularies of major payers? For digital therapeutics companies investing in randomized controlled clinical trials, GMP manufacturing and FDA submissions for products, the current absence of public health insurance coverage is frustrating.
