COVID-19 has accelerated the use of digital therapeutics, but coverage issues and regulatory issues could slow their momentum


Digital therapies – clinically tested tools that deliver medical interventions through software – have been gaining traction for years, with products that treat a range of conditions, including diabetes, mental health issues, and cancer. Today, the explosive growth of the digital health arena during the COVID-19 pandemic is helping these companies carve out a niche for their products, but the young sector still faces regulatory and payers challenges that could. slow its widespread adoption.

the first digital therapeutic prescription to be approved by the Food and Drug Administration was Pear Therapeutics Inc.’s mobile application in 2017 for patients with substance abuse disorders; there is today around 35 to 40 products on the market, although the FDA does not clearly define digital therapeutics. Another tool from Cognoa Inc., for example, helps doctors diagnose autism faster by asking parents to submit information about their young children’s behavior in an app that also takes doctors’ responses into account.

The difference between these products and the thousands of wellness apps or non-prescription digital health tools available is that “they’re going to provide a clinical outcome, or significantly facilitate that outcome in a very direct way,” Bill said. Evans. , Managing Director of Rock Health, a venture capital fund focused on digital health startups.

Despite the medical benefits, a new Morning Consult investigation alludes to an impending challenge for these tools: clinician and patient confidence. Some digital therapies rely heavily on artificial intelligence, and in the survey, 42% of adults said AI can help clinicians provide better health care, while 21% said AI can deliver better health care. more difficult to provide quality care and 37% did not know or did not have an opinion on the issue. Overall, men were more likely than women to embrace AI in healthcare.

Public perception may change as these products become more widely used. During the pandemic, federal regulators loose certain requirements to make digital health tools more accessible, and digital therapy companies saw an opportunity to prove their worth. In April 2020, for example, Omada Health Inc. ad that its digital mental health tool would be available free to all commercial health plans over the next six months.

An FDA spokesperson said the agency “would like to see more evidence-based products in this area,” but declined to comment on flexibilities that could last beyond the pandemic.

The path of digital therapeutics to the marketplace is also quite unique. Investigational drugs can undergo years of expensive research and clinical trials, but with digital treatments, “technology by nature – which is why it is so attractive – is easier to implement and less risky” to study Evans said.

“There are some really promising case studies out there, and now companies are doing very well because they did a good job,” which proves the value of their products, he added.

Getting these products to market, however, is only half the challenge. Because they are so new, there is no specific benefit category for digital therapies in Medicare, which means that the public Medicare program for the elderly has not always reimbursed them. clinicians who prescribe them. Megan Coder, executive director of the Digital Therapeutics Alliance, a coalition of manufacturers, said private insurers have expressed more interest in covering these tools and companies are increasingly making them available to their employees.

More than 50 company health plan coverage Kaia Health’s mobile app to help consumers manage chronic pain on their own through virtual physiotherapy, for example. The app uses an algorithm to provide daily personalized exercises, and a 2019 clinical trial found it to be more effective at reducing back pain in patients than physiotherapy with online patient education.

At the end of 2019, Express Scripts, manager of pharmaceutical benefits of Cigna Corp. launched a digital health form to help employers and health plans determine coverage, starting with 15 remote monitoring services and digital therapies that he reviewed for clinical effectiveness, usability, safety and financial value. The company added five other tools form in October, targeting issues such as women’s reproductive health, smoking cessation, and muscle and joint pain.

“The pandemic has rapidly accelerated the adoption of digital health solutions,” particularly for tools to combat depression, anxiety and insomnia, said Mark Bini, head of patient experience at Cigna’s Evernorth, which absorbed the Express Scripts brand last year.

The form “already saves plans an average of $ 120,000 per solution in administrative costs,” Bini said.

Coder warned that the gap between public and private plan coverage could lead to gaps in access for patients with public health insurance, “a growing disparity that will continue to grow until this problem is resolved. “.

His professional group is awaiting two decisions that could help advocate for increased coverage of digital therapies: Upcoming changes to Medicare’s physician fee schedule could make it easier for clinicians to get reimbursed for the time they spend. to use these tools. And the Centers for Medicare and Medicaid Services should make a final call in mid-December on a Trump-era rule that would automatically grant Medicare coverage for newly approved “breakthrough” medical technologies for four years.

Medtech companies favored the rule, but insurers and providers repulsed, arguing that there are questions about their effectiveness and that these tools should go through existing coverage channels. A CMS spokesperson said the delay “left more time to review the provisions of the current rule and make decisions on future steps.”

Yet even though insurers offer digital therapies to patients, their availability doesn’t mean much if clinicians don’t understand their capabilities and patients are reluctant to use them. Morning Consult’s survey indicates that American adults were the most likely to say digital health tools are convenient, safe and accurate, although at least a third also find them difficult to use, scary or confusing.

The survey was conducted June 4-7 among 2,200 American adults and has a margin of error of 2 percentage points.

Even as health insurers reflect on how to evaluate these tools and clinicians strive to make them accessible to patients, Coder noted that countries like South Korea and Germany have taken steps to make them more widely available – and that this change should not slow down. soon.

“As the healthcare ecosystem evolves, digital therapy is an essential part of it,” Coder said.


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