Shortly after approving the first prescription mobile app to help treat opioid use disorder in December, the FDA released a drafted regulatory framework for the review of digital therapeutics, issuing various guidance documents in order to streamline oversight for new digital therapeutic programs.
These developments – along with the fact that $12.5 billion was invested in digital therapeutics from 2017-2018 and over 140 efficacy studies involving digital health tools were published in 2017 alone – indicate that the field of digital therapeutics may see more advances in 2019.
But to many this just raises the question; what exactly are digital therapeutics?
A Working Definition
Digital therapeutics is the discipline of using evidence-based technology to help patients make behavioral changes that contribute to improved health outcomes for specific health concerns. This can involve mobile apps, medical devices, and other electronic modalities, so long as treatment relies on behavioral and lifestyle changes spurred by a collection of digital impulses.
Digital therapeutics differ from general digital health products in that digital therapeutics are evidence-based with studies or clinical trials that demonstrate some form of clinical value for a specific medical condition. One significant differentiator is that reputable digital therapeutics can earn FDA approval to help treat certain illnesses and injuries.
Potential Applications
Perhaps most significant to workers’ comp at the moment is the FDA-approved reSET-O prescription app from Pear Pharmaceutics, which serves as an adjunct therapy for the treatment of opioid use disorder. The app is prescribed on top of traditional buprenorphine use and an out-patient therapy program, using cognitive behavioral therapy lessons to reinforce treatment lessons and train, monitor and remind patients to maintain therapy, allowing them to self-report cravings, drug use, and other factors.
Based on patient interaction, the app uses a compliance reward system to increase retention in treatment programs. In a multi-site, unblinded controlled 12-week clinical trial of 170 patients, groups that used the reSET-O app – in addition to traditional therapy – demonstrated an 82.4% retention rate, versus the control group – which underwent just traditional therapy – who achieved a 68.4% retention rate.
Pear Pharmaceutics also gained FDA approval for the Reset prescription app, which is used to treat substance use disorders for stimulants, cannabis, and alcohol. In clinical trials this app – in combination with traditional therapy – helped produce more than double the rate of drug abstinence when compared to traditional therapy alone.
There are currently FDA-approved prescription digital therapeutics on the market for asthma and COPD, diabetes, and more. But beyond these medical conditions, digital therapeutics have the potential to benefit any health problem that has an evidence-based behavioral or psychological component. And as the FDA has previously established a software pre-certification program to help assist the development of digital therapeutics, more products could potentially see approval down the road, including those that could help treat:
- Back pain
- Traumatic brain injury
- Post-traumatic stress disorder (PTSD)
- Epilepsy
- Insomnia
- Depression
- ADHD
- Schizophrenia
- And more
Possible Benefits
While there is still much to learn surrounding digital therapeutics, the following have been discussed as possible benefits of embracing digital therapeutics
- Improving treatment adherence
- Patients could report fewer medication concerns if digital therapeutics reduce the need for certain medications
- When working with software, potential glitches and user issues can be patched and fixed in a timely manner, unlike pharmaceuticals, where concerns uncovered in the real world may require new formulations that take a considerable amount of time to develop
- Digital therapeutics allow for the collection of real-time therapeutic insights and patient data, potentially helping providers and insurers to more effectively manage health
- Lower costs; according to one report from MIT Technology Review, an app that helps treat insomnia costs $400 for a one-year subscription, while six Ambien tablets cost $73
The Current Forecast
According to a provider survey from PwC, 54% of consumers are very or somewhat likely to use an FDA-approved digital therapeutic, and 56% of doctors have discussed them with patients. In fact, the survey reported that 77% of doctors have recommend some app or digital program to patients, with 66% of doctors saying this led to an improvement in the patient’s treatment experience.
There appears to be much interest in digital therapeutics, but like any new technology or healthcare tool, there is still much more to learn. More clinical trials and operational insights are necessary to understand how well digital therapeutics may work, and more consumer information is necessary.
Furthermore, there would be a need to establish frameworks to integrate digital therapeutics into the current healthcare system. On top of potential legislative issues, questions of reimbursement and data collection arise, and then there is the general slow speed of healthcare and workers’ comp to embrace new technologies. It may still be some time before digital therapeutics renovates care, but it is certainly a topic to monitor.
