Digital Therapeutics Have Arrived But Will Insurers Get On Board?

 
• By Ben Comer

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.

748519186 Mock up image of Asian boy touching the tablet on the table. Endeavor Geyser
Akili Interactive's FDA-cleared EndeavorRx prescription video game for ADHD

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.

This is particularly true in the case of digital therapeutics, defined here as FDA-cleared prescription digital applications used by patients...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Innovation

This Belgian Biotech’s Drug Cocktail Could Help Reverse Muscle Aging

 
• By Jo Shorthouse

While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.

Podcast: Brain+ CEO Discusses “Groundbreaking” Potential Of CST Assistant For Dementia Patients

 
• By Anabel Costa-Ferreira

Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the hurdles in scaling digital innovation and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

More from In Vivo

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Rising Leaders 2025: Ovid’s Meg Alexander On Neurology’s Next Frontier

 
• By Jo Shorthouse

Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.