Digital therapeutics are here to stay. The promise of improved access to care and novel treatments for conditions with high unmet needs will likely allow this treatment category to flourish, despite some of the challenges and complexities they present.
One of the first complexities is defining digital therapeutics. How are they different from your average wellness app? To start, the sheer number of available assets is notable. While there are over 350,000 digital health apps currently available, there are currently only 48 commercially available digital therapeutics.
Digital therapeutics must provide a form of clinical intervention, from improving a health function to managing a disease, and include both prescription and over-the-counter solutions. Digital health is a much broader category and spans a wide range of uses, from applications in general wellness to applications as a medical device.
Types of digital therapeutics
These novel treatment options represent a diverse landscape of evidence-based digital interventions that can prevent, manage or treat a broad spectrum of physical, mental and behavioral conditions. They are designed to help treat disease by either complementing or replacing other therapies (i.e., pharmacological) and may employ strategies rooted in cognitive behavioral therapy.
All digital therapeutics are assessed by the U.S. Food and Drug Administration (FDA). Based on the level of risk and any medical claims made by the manufacturer, the FDA determines whether the product should require a prescription—in which case they follow the Medical Devices De Novo or 510(k) pathway—or whether they can be exempt and made available over the counter. The approval process usually includes at least one randomized clinical trial. In many cases, developers also include real-world evidence to demonstrate clinical effectiveness and benefit to patient outcomes.
Market landscape
The COVID-19 pandemic has significantly increased demand for convenient and accessible digital health solutions.
Digital therapeutics are developing at a rapid pace to meet that demand, with 25 therapeutics granted market authorization through some type of regulatory process worldwide, in addition to 23 other commercially available solutions and approximately 89 in the pipeline, as of mid-2021.
Benefits and opportunities
Digital therapeutics offer several potential benefits to patients’ overall experience and health outcomes.
- Safety: Since digital therapeutics do not interact with the human body in a direct way, they have the potential to be safer that traditional medication therapy in some instances.
- Convenience: Digital therapeutics can also improve convenience and accessibility of care by offering virtual interventions that allow for on-demand care and continual engagement (e.g., substance abuse, mental health). Care that is typically provided in a more expensive setting can be brought to patients’ homes, making it more convenient for them to stick to the care plan.
- Access: Digital therapeutics can help overcome transportation, location, language and stigma barriers.
- Treatment options: Digital therapeutics can also provide alternate treatments for high-spend conditions that are insufficiently addressed by traditional therapies, such as fibromyalgia and chronic pain.
- Better condition tracking: Digital therapeutics can support patients in day-to-day condition management by mapping improvements in outcomes around clinically validated benchmarks
At CVS Health, we continually monitor the market to find new and innovative solutions for our clients. Our Point Solutions Management product enables our clients to simplify contracting, secure the lowest price and monitor ongoing performance of third-party non-prescription digital healthcare solutions that are internally evaluated from a safety and efficacy standpoint. We are also currently exploring a framework for evaluating prescription digital therapeutics in order to enable sound coverage decisions for payers looking to offer these solutions to their members.
To fully realize these potential benefits of digital therapeutics, much more needs to be done to increase not just education and awareness but also clarity including what is considered a true digital therapeutic, consistency in regulatory and evaluation processes, and real-life evidence and data gathering.
It is critical that players across all healthcare sectors collaborate and find workable solutions in a patient-centric and cost-effective manner.
Daniel Knecht, M.D., is the chief clinical innovation officer for CVS Caremark.