Digital technology has had such a deep and profound impact on healthcare that it has spawned a new term – digital health – and an industry with multiple stakeholders, including clinicians, consumers, software and hardware vendors, labs, scientists, researchers and public health officials.
Exceedingly broad in scope, digital health includes mobile health (mHealth), telehealth and telemedicine, consumer wearable devices that track user activity and monitor vital signs such as heart rate, patient portals and personalized medicine. The vast amounts of data collected by digital devices, along with the analytics platforms, artificial intelligence (AI) and machine learning that make sense of that data, today are being used to support clinical decisions and guide public health policies.
“Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of healthcare for the individual,” the Food and Drug Administration (FDA) writes
. The Agency has been very supportive of digital health, creating the Digital Health Center of Excellence (DHCoE) in the fall of 2020 to provide regulatory advice and support to the FDA’s regulatory reviews and to create a network of partnerships to advance and realize the potential of digital health technologies.
An emerging field in which digital tools are being used in healthcare is digital therapeutics (DTx), where software-based interventions are used to treat, manage, or prevent a disease or disorder. Today DTx companies are gathering evidence through clinical trials, studies of real-world evidence (RWE), claims data and other relevant sources and then apply for approval or clearance to the FDA’s Center for Devices and Radiological Health or other global regulatory agencies. The global DTx market is projected
by Allied Market Research to reach a value of $23.6 billion by 2030, more than six times the 2020 value of $3.6 billion.
DTx have been developed to address a wide range of physical and mental health issues. There are products that deliver cognitive behavior therapy, improve medication adherence, regulate insulin doses, cope with opioid use disorder, manage musculoskeletal pain and deal with insomnia.
Non-digital products are approved by the FDA in a final form, such as a pill. Should a pharmaceutical company make changes to that pill, it would have to gain approval by the FDA once again to bring it to market. But many DTx products change over time because they adapt to users. For example, Akili Interactive markets a prescription DTx video game, EndeavorRX, for children with ADHD. The game adapts to players as they use it. So Akili must evolve the gameplay experience by adding new features and functionality to retain its effectiveness as a treatment.
This requires a new process for approving products that could include a pre-certification process with support from the DHCoE and then submission of clinical evidence to gain FDA approval or clearance. The challenge here is that even if a DTx company wins regulatory approval or clearance, there is no guarantee that payers are going to provide reimbursement. They may conclude that there is insufficient evidence to support the coverage of a particular product.
To accelerate the adoption and integration of DTx into healthcare, the non-profit Digital Therapeutics Alliance (DTA) was formed in 2017 by DTx technology manufacturers from around the world. Since its inception, DTA has grown to more than 70 members. Among those supporting DTA is Curebase, which recently announced a research and education partnership designed to help DTx organizations conduct effective clinical trials.
How do you generate clinical evidence for your product? What clinical evidence do you need for your product? And how do you design clinical trials or other research to generate that clinical evidence? These are questions our efforts with DTA hopes to answer.
There are no cookie-cutter solutions or processes because different stakeholders often want different data. While regulators may want to see a lot of safety data before granting approval or clearance of a DTx product, payers may be more interested in data on treatment durability. For example, they might want to know whether a 12-week cognitive behavioral therapy app is going to help patients after a year or two.
If anything, digital therapeutics manufacturers are being held to almost a higher standard than some of the drug companies because there isn't standardization around what kind of clinical evidence applicants must provide to have their products accepted by both regulators and payers. This is part of the reason why some DTx companies are trying to go direct to patients or working with employers to provide DTx treatments to employees. These routes, however, present their own challenges.
While the list of DTx treatments approved by the FDA and other regulatory agencies around the world continues to grow, much work remains to establish industry expectations and educate regulators, DTx vendors, payers and providers. It’s still hard for many people to grasp that software itself can be the treatment.
Shifting mindsets isn’t easy. Persuading regulators, payers, providers and patients about the effectiveness of DTx will take time and evidence in the form of studies that include real-world data and results. Fortunately, that evidence is growing daily.
About the author: For more than a decade, Adam Samson has helped to conduct clinical trials across multiple therapeutic areas within academia, sites, CROs, pharma, and tech. He currently serves as the senior director of clinical operations and customer success at Curebase, a software and services provider purpose-built for decentralized clinical trials (DCT). Samson also serves as adjunct faculty at The George Washington University in the Master's in Clinical Research Administration program.