Prescription digital therapeutics

Rebecca, a 20-year-old college student, was suffering from social anxiety, a mental disorder characterized by extreme fear in social settings. She had anxieties about people judging her for what she eats, how she eats, and dining etiquette. The counseling sessions she enrolled in did not help much, partly because she missed appointments for assorted reasons. Upon her doctor’s prescription, she subscribed to a digital mental health therapy.

Despite some early concerns, Rebecca went ahead with the cognitive behavioral therapy, which was delivered over digital platforms such as a mobile app and laptop. The therapy used gamified exercises, chatbots, and user videos. To her surprise, Rebecca overcame her fear and began participating in social gatherings confidently. The digital therapy enabled her to get treatment from the comfort of her home without missing any appointments. This also allowed her therapist to finetune the treatment based on her progress, using the data from the digital platform.

Such evidence-based interventions driven by software applications for the management of a medical disorder are called digital therapeutics (DTx), a subset of digital health that is receiving lot of attention. Those DTx products which are approved by the FDA and prescribed by doctors are known as prescription digital therapeutics (PDTx).

Growing markets driven by healthcare needs and patient preferences 

DTx has been a hot topic due to its potential to change the way care is delivered and how the granular patient data can be effective in making informed treatment interventions and decisions. As the coverage pathways for prescription digital therapeutics widened, the investments in those digital products that support disease treatments increased around 2.6 times between 2020 and 2021. Major investments were made for mental health, diabetes, and cardio-vascular condition treatments. This trend mirrors the increasing consumer demand for digital therapeutic products for various conditions related to psychiatry, respiratory, endocrinology, addiction, cardiovascular, and others. The combined market of prescribed and non-prescribed digital therapeutics is projected to reach from $3.4 billion in 2021 to $56.1 billion by 2025, an upward revision from the original estimate of $13.1 billion due to pandemic related factors. 

DTx will accelerate the healthcare industry’s pursuit of value-based care, virtual care, and personalized medicine. These solutions allow providers to deliver patient-centric care through an interactive and customized therapy administration at the patient’s convenience. This can improve patient experience and, in turn, can improve treatment adherence and health outcomes while eliminating unwanted administrative efforts for providers. 

As the world moves towards the metaverse era, where the physical and virtual worlds coincide, DTx has immense potential to make a revolutionary impact. DTx can take personalization to the next level due to its extreme compatibility with digital twin technologies. In the near future, patients and clinicians can interact in the virtual world just as in the real world. Imagine counseling sessions with avatars or confronting anxieties in a virtual reality simulation. The key here is to ensure interoperability of data which makes the intra-metaverse communications swift and seamless, complying with the regulations. 

Prescription digital therapeutics

Prescription digital therapeutics (PDTx) are software-based therapeutic interventions prescribed by a healthcare provider, as in the case of Rebecca. They are evidence-based therapies with proven clinical efficacies and are approved by regulatory authorities for the management or treatment of specific medical conditions.  

In September 2017, Pear Therapeutic’s mobile application “reSET®” became the first PDTx to be approved by the Food and Drug Administration (FDA) for use in patients with substance abuse disorder. Today, the number of approved PDTx stands at around 40. Recently, Akili Interactive’s video game-based therapy named EndeavorRX received FDA clearance for attention deficit hyperactivity disorder (ADHD) in children.

Factors driving the adoption of PDTx

The success of PDTx lies in how well it is accepted by providers, which in turn depends on payers’ willingness to appropriately reimburse providers for digital therapies. A joint survey conducted by Pear Therapeutics and Avalere indicated that only 40% of payers covered PDTx in 2021, and 50% plan to cover it in the next 18 months. The key factor would be the clinical efficacy of PDTx in improving patient outcomes. With a recent slew of regulatory and FDA approvals for PDTx and most payers willing to cover PDTx reimbursements in the future, it is encouraging for PDTx manufacturers as they continue to innovate. 

Other critical factors include:

• Product design: PDTx developers must design the products using a human-centric design approach that considers the core needs of all the users, their environment, and the devices through which digital therapy is administered. For instance, the PDTx solutions must focus on features such as user friendliness, seamless navigation, user engagement, and the availability of essential resources like videos and articles.
  
  
• Integration: The PDTx product should integrate seamlessly with existing provider and payer workflows. This can create a superior and consistent user experience on a mobile application or the web and integration with the provider’s electronic health record (EHR) systems. The integrations with clinical systems must be done using industry standards such as FHIR (Fast Healthcare Interoperability Resources) and SMART (Substitutable Medical Apps, Reusable Technologies) to achieve security, reliability, and interoperability across entities.
  
  
• Provider/Patient education and training: All the stakeholders in the healthcare ecosystem would need to contribute to improving the effective use of PDTx by the providers and the patients via streamlined education, support, engagement, and empowerment.
  
  
• Affordability: PDTx solutions are not inexpensive but cheaper and more easily accessible than other interventions such as surgeries. Their value must be evident through their effectiveness, experience, and ability to eliminate other expenses. 
  
  
• Privacy and security: With stringent regulatory measures in place around PHI (Personal Health Information) data, all the players involved in the development and use of digital therapeutics must strive to preserve the privacy and security of the data collected. For instance, manufacturers must adhere to HIPAA (Health Insurance Portability and Accountability Act) regulations to safeguard the privacy of patients’ data based on a standardized security framework and work with partners that are HITRUST- (Health Information Trust Alliance) certified to ensure regulatory compliance of data flows.
  
  
• Alignment to value-based care: With healthcare moving towards value-based care enabled through healthcare data interoperability, the alignment of PDTx with it would be very crucial to driving its adoption by all the stakeholders. 

Figure 2: Adoption factor relevancy for providers, payers, and patients.

These factors can be addressed by engaging relevant stakeholders early in the development process and better education around the usage of PDTx. For example, engaging clinicians and payers early in the product development lifecycle to understand their processes and challenges will allow PDTx developers to apply design thinking principles to deliver a better experience. 

As in Rebecca’s case, users are likely to be concerned about the efficacy of digital solutions as compared to face-to-face treatments. This is where delivering the right experience becomes key. While the providers’ role is pivotal, PDTx solution developers must focus on user engagement by providing relevant content based on user mood and behavior, smooth user experience workflows, gamification, and 24x7 customer support. Providing real-time alerts to therapists on the progress and challenges of the patient can go a long way in making the healthcare experience truly world-class.

The road ahead for PDTx

While patients embrace digital health solutions, as evident from the exponential rise of telehealth consulting since the COVID-19 pandemic, the actions of payers and providers in the coming years will determine the growth of PDTx solutions. Providers need to start formalizing strategies to leverage PDTx to improve patient outcomes while payers develop reimbursement protocols to encourage the use of PDTx.

Interestingly, few countries like Belgium and Germany have implemented national frameworks for the reimbursement of digital health products. In the U.S., pharmaceutical benefits managers like ExpressScripts and CVS Caremark launched their digital formularies to enable health plans and employers to choose the best digital product for the beneficiaries. These include digital therapeutic products like Livongo and Omada (Diabetes and Hypertension family of products), Life Scan OneTouch Reveal Plus, Sliver Cloud Health (Mental Health Platforms), etc. But that is just the start of what is possible.

To utilize PDTx to its full advantage and reduce the risks involved, healthcare systems will need new frameworks to measure patient outcomes and support digital literacy. They must be built along with resilient information systems and scalable strategies through technology partnerships to address privacy and security concerns. PDTx generates a large amount of real-world data, which demands platforms that are scalable and secure. The success of PDTx manufacturers depends on bringing technological innovations (e.g., intelligent automation) to the application, finding the right commercial model, and choosing the right partners based on their shared vision, innovation, and culture.

It benefits patients, providers, and payers to keep PDTx in the mainstream of care delivery and align incentives to get the best outcomes for everyone.