Among the innovative technologies that could boost health outcomes and value, Digital Therapeutics (DTx) hold great promise. A June 2022 National Academy of Medicine report suggests that DTx could yield earlier diagnoses and treatments; more effective, coordinated, and continuous care; stronger patient engagement; and greater efficiency – all through a convenient smartphone app or video game.  

So what exactly are Digital Therapeutics? 

According to the non-profit trade association, Digital Therapeutics Alliance, DTx deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. DTx services are distinct from the many health and wellness apps that simply track calories or count steps in that they are specifically designed to treat disease. Early DTx have focused on asthma, anxiety, diabetes, post-traumatic stress disorder, and ADHD, with solutions for a wider range of conditions under development. DTx may use sensors and AI-based algorithms to provide real-time feedback to patients and providers or offer customized coaching.  

What are Prescription Digital Therapeutics?
Prescription Digital Therapeutics (PDT) are subject to peer-review clinical trials that confirm their ability to improve peoples' lives. They receive FDA approval and are prescribed by a clinician. PDT can be used in conjunction with other medications or therapies, or as standalone treatments under a clinician’s oversight. A few leading, FDA-approved PDT include: 

• Pear Therapeutics has three prescription software treatments for substance use disorders and insomnia.
  
  
• Akili’s EndeavorRx prescription videogame treatment helps children with ADHD improve attention function by navigating a space ship through obstacles. 
  
  
• EaseVRx, by Applied VR, is a virtual reality software that uses cognitive behavioral therapy to reduce lower back pain with relaxation techniques, distraction, and behavior modification.
  
  
• BlueStar, developed by Welldoc, is prescribed for adults with Type 1 or Type 2 diabetes to suggest in real-time when users should test their blood sugar and how to control it by adjusting food intake and exercise. 

What should be considered when evaluating DTx?

DTx advocates think most disease conditions will include a software solution as a first-line therapy in the next decade. Yet, payers and providers have been slow to embrace these technologies. Eager to create pathways for reimbursement, product innovators have pursued distribution through the major Pharmacy Benefit Managers, some of which now offer PDT formularies. Early-adopter employers are beginning their due diligence in evaluating available PDT with the following questions: 

(1) Clinical and Cost-Effectiveness - Is the evidence strong enough to pay for treatments that resemble free or low-cost smartphone apps? How will cost-effectiveness be measured and reported? What is the expected duration of treatment and cost? Given their newness, a standard FDA process for vetting PDT does not exist. As the controversy surrounding Biogen's Alzheimer's drug made clear, employers cannot always use FDA approval as a proxy for clinical effectiveness. Fortunately, PDT innovators are hustling to amass an evidence base for their products. Employers should expect evidence of clinical trials and value to exist, along with indicators of patient acceptance. Kaia Health, for example, points to a randomized controlled trial showing that patients using its solution to treat lower back pain had medical claim costs that were 80% lower than those using standard therapy. Performance guarantee should be expected. Bipartisan legislation in the pipeline may expand Medicare coverage of PDT. If this passes, the coverage of specific products by the Centers for Medicare and Medicaid Services could be a helpful indicator of clinical and cost-effectiveness.

(2) Purchasing Intermediary and Process - A digital “formulary” is a catalogue of vetted apps that PBMs or health plans offer. Would your organization prefer to go through one of these intermediaries to purchase or go direct? Do PDT have rebates and administrative fees, and are these disclosed? Does your health plan or PBM contract ensure that all revenues earned from products or services used by your enrollees are returned to the plan sponsor? 

(3) Patient Cost and Plan Design - Does your plan design language need to be updated to account for PDT and DTx? How will patient cost sharing being structured and the benefit of PDT be communicated? 

Ready to explore further?

While DTx and PDT could be attractive solutions for patients, physicians, plans, and employers, many questions remain to be answered. BHC members looking to learn more are invited to attend our next Pharmacy Meeting on September 13 at 2:00 PM (CT) as we discuss the PDT and DTx landscape, offerings currently available through PBMs, and considerations for employers prior to implementation.

Warm regards,

Louise Y. Probst,

BHC Executive Director