Current State of Digital Therapeutics and the Reimbursement Environment

The Digital Therapeutics Alliance defines digital therapeutics as products that “deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.”  The interest and studies revolving around digital therapeutics have only grown in the last decade.  Curiosity in the possibilities of digital therapeutics used to be confined to academia and technology companies.  Today, pharmaceutical companies are seeing the potential of digital therapeutics and becoming increasingly involved through strategic investments and partnerships with various technological companies1.

The world of digital therapeutics can be complex and convoluted with the various terms.  It is crucial to understand these terms when discussing digital therapeutics.  Some of these key terms are as follows:

  • Digital Health is defined as the space where digital technologies, daily life, and healthcare intersect.
  • Digital medicine describes a field concerned with the use of technologies as tools for measurement and intervention in the services of human health. In a broad sense, digital medicine is technology that supports the practice of medicine.
  • Prescription digital therapeutics are FDA-authorized software programs that providers may prescribe as a form of treatment2.

Digital therapeutics are becoming more widely available.  There are both non-prescription and prescription digital therapeutics.  Some non-prescription products include Daylight®, deprexus ®, and HelloBetter Vaginismus Plus®. Often, a smart device and internet connection is all that is required to utilize the non-prescription products.  Some prescription digital therapeutic products include Insulia®, Nerivio®, and Somryst®3.  The same general hardware and software requirements for the non-prescription products are needed for the prescription products4.  Some digital therapeutics are listed in drug compendia.  Bluestar®, reSET®, EndeavorRx®, and many others are listed in Medi-Span® Price Rx®, where the products are assigned a generic product identifier (GPI) code that can affect reimbursement decisions.

There are many factors that are weighed when it comes to reimbursement of digital therapeutics, but the compendia play a significant role in reimbursement decisions for many payers.  Products that are listed in unique or specific categories, as opposed to more general categories, may have a greater probability of being reimbursed by payers.  The compendia listing is a crucial beginning step in becoming a product on a payer’s formulary.  Without compendia listings, it can prove difficult for a digital therapeutic product to be picked up by a payer.  Similarly, compendia listings are also crucial in having a digital therapeutic product included in an EHR e-prescribing platform and having that product added to a patient record.  Having a product in an EHR may enable the prescriber to perform a real-time benefits investigation.  All these factors, on top of rigorous clinical trial data, prescription status, and intended use, will be utilized by payers to determine the coverage and reimbursements of digital therapeutic products1.

Reimbursement for digital therapeutics is uncharted territory for many payers.  The temporary solution is a direct-to-consumer model in which users are paying subscription fees, but a value-based model where payment is based on patient outcomes is being investigated.  A great deal of evidence would be required to support claims and demonstrate efficacy.  This shows the importance of digital formularies to create confidence in evidence-backed digital therapeutics for providers and payers to increase utilization.

Digital therapeutics are projected to grow over the next decade.  The past decade has seen trends in digital therapeutic research focused on solutions for cardiovascular diseases such as hyperlipidemia, hypertension, and acute coronary syndrome.  Currently, there is still research dedicated to these cardiovascular diseases, but there is also a focus on a wide range of psychiatric indications, including attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, schizophrenia, depression, and bipolar disorder.  The FDA has taken notice of the rise of digital therapeutics.  As a part of the 21st Century Cures Act, the FDA Breakthrough Devices Program offers manufacturers an opportunity to collaborate with experts within the FDA to address any premarket concerns and make timely and agreed upon adjustments.  The goal is to give providers and patients quicker access to digital therapeutics while still being confident in the safety and efficacy4.  This places digital therapeutics in more of a position to grow and find their role in treatment plans. What do you think the future of digital therapeutics looks like?

 

References

  1. AMCP Partnership Forum: The evolving role of digital therapeutics. https://www.jmcp.org/doi/epdf/10.18553/jmcp.2022.22093. Accessed July 12, 2022.
  1. Talking HealthTech. Digital Health, Digital Medicine, and Digital Therapeutics; what is the difference? Talking HealthTech. https://www.talkinghealthtech.com/glossary/digital-health-digital-medicine-and-digital-therapeutics-what-is-the-difference. Accessed July 12, 2022.
  1. Product library. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx/product-library/ Published May 27, 2022. Accessed July 12, 2022.
  1. Burke J. White Paper: Digital Therapeutics: Past Trends and Future Prospects. https://www.evidera.com/digital-therapeutics-past-trends-and-future-prospects/. Published March 8, 2022. Accessed July 12, 2022.

 

Posted: October 2022

Leave a Reply