Rédaction Africa Links 24 with G. Luke Hartstein and John Torous
Published on 2024-02-01 09:30:28
South Korea has distinguished itself as the only country to formally recognize digital therapeutics as a distinct category. This is in stark contrast to the United States, where digital therapeutics have garnered considerable attention and investment, but have recently faced significant setbacks, including billions of dollars in bankruptcies in 2023. The future of this field, which includes software-based tools designed to manage or treat medical conditions, is being threatened by a combination of regulatory hurdles and deeper structural challenges.
One of the main hurdles facing digital therapeutics in the U.S. is the lack of a clear Medicare benefit category as required by the Social Security Act. This makes it challenging for these types of services to be covered by the Centers for Medicare and Medicaid Services. The act mandates that Medicare benefit items and services must be deemed “reasonable and necessary for the diagnosis or treatment of illness or injury,” a more rigorous standard than the “safe and effective” criterion used by the FDA for drugs and devices.
As a result, digital therapeutics do not neatly fit into existing Medicare benefit categories, leading to challenges with reimbursement and coverage. One argument has been made for digital therapeutics to be included under the durable medical equipment (DME) category, but CMS has interpreted this definition too narrowly, resulting in denials for companies like Pear Therapeutics, which eventually declared bankruptcy.
Efforts to pass legislation to create a new benefit category for digital therapeutics began as early as 2020 but have made minimal progress. Commercial payers also have reservations about the efficacy of digital therapeutics, citing a lack of convincing evidence to support their use. Studies have indicated low engagement and a dearth of understanding of the mechanisms of action of digital therapeutics, raising concerns about their clinical utility and cost-effectiveness.
In response to these challenges, large players in the industry are experiencing setbacks, with companies like Akili and Biogen scaling back or shuttering their operations. Two possible paths forward have been proposed for the digital therapeutics industry. One approach involves conducting large, placebo-controlled randomized trials to demonstrate clear evidence for digital therapeutics, aligning them more closely with the standard of evidence required for pharmaceuticals.
The other approach involves reimagining the framework in which digital tools are incorporated into medical care, emphasizing hybrid care models that integrate digital solutions into a comprehensive treatment plan. This model involves evolving reimbursement frameworks and selling digital therapeutic products to providers for reimbursement by third-party payers.
Overall, the field of digital therapeutics faces significant challenges in the U.S., including regulatory barriers, lack of clear reimbursement pathways, and concerns about evidence and clinical utility. However, there are potential paths forward that involve conducting more rigorous studies and reimagining care delivery to better integrate digital tools. These approaches may lead to a more sustainable future for digital therapeutics.
