One might think getting 10,000 steps and closing your rings is a digital therapeutic, but Digital Therapeutic (DTx) is a whole different thing. DTx delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. DTx products must be proven effective via rigorous testing through randomized controlled trials (RCTs), ongoing real-world evidence generation, and analysis of product performance data. The clinical trial results are typically published in peer-reviewed journals.1
While the uptake has been variable, DTx through its rigorous testing, strong evidence generation, and the ubiquitous uptake of devices, and media is poised to see it place in treating disease grow exponentially. In fact, a sector analyst recently revised their 2025 forecast opportunity from $9 billion to $56 billion driven by pandemic demand for digital access to care and an uptick in merger and acquisition of DTx companies. Additionally, pharmaceutical companies are becoming more active through partnerships and acquisitions of DTx providers.2
While the investment in DTx continues to grow, a record $24 billion in 2020,3 so does its potential to disrupt how diseases are treated. A couple of examples are the recent FDA clearances (similar to an approval for a drug) for several DTx in the behavior health space. Patients who struggle with attention deficit and hyperactivity disorder (ADHD)4 or substance use disorder (SUD)5 now have a digital therapy as an option that can be delivered in the palm of their hands. Both options can be used in conjunction with traditional therapies, such as drugs, or by themselves. In particular, behavioral health has been a sweet spot for DTx, with a majority of the 25 DTx products granted market authorization through regulatory processes focused on mental health and behavior modification areas.6 DTx innovations now have to contend with the “last mile,” which is the last stage in delivering a good or product to a consumer and is often the most complex and difficult problem to solve.7
For instance, both the ADHD and SUD products are prescribed digital therapeutics (PDTs), which means they require a healthcare provider to prescribe them to a patient and they then must be dispensed. In order for PDTs to be widely accessible, several operational hurdles will need to be overcome. To this end, in September, more than 40 industry experts gathered at the Academy of Managed Care Pharmacy Partnership Forum on Digital Therapeutics to discuss several topic including the challenges patients face in accessing therapies.8 The managed care industry is now at a tipping point when it comes to defining and broadly increasing coverage and access.
As the patients demand more “digital” satisfaction from every facet of the healthcare system, it will be incumbent on payers and manufacturers to further incubate this emerging therapeutic category or they risk being outmoded. An initial step would be for payers to create more structure on “where” and “how” they plan to cover DTx and outline what is needed by manufacturers when seeking access. Each DTx manufacturer should consider the optimal approach for demonstrating their innovations value and driving toward a consistent and equitable coverage, similar to drugs.
- Digital Therapeautics Alliance. Understanding DTx. https://dtxalliance.org/understanding-dtx/. Accessed October 19, 2021.
- Insider Intelligence. Digital Therapeutics Report: Latest DTx market trends and companies in growing digital health sector. https://www.insiderintelligence.com/insights/digital-therapeutics-report/. Published July 29, 2021. Accessed October 19, 2021.
- Sluijs M. DigitalHealth.Network. Digital Health Marketscan. 118th ed. December 2020. $24Bn invested: Don’t look back!
- EndeavorRx. Homepage. https://www.hcpendeavorrx.com/. Accessed October 18, 2021.
- Pear Therapeutics. reSET & reSET-O. https://peartherapeutics.com/products/reset-reset-o/. Accessed October 18, 2021.
- IQVIA Institute. Digital Health Trends 2021 Institute Report. https://www.iqvia.com/insights/the-iqvia-institute/reports/digital-health-trends-2021. Published July 22, 2021. Accessed October 18, 2021.
- Hesse BW. Role of the Internet in solving the last mile problem in medicine. J Med Internet Res. 2019;21(10):e16385.
- Academy of Managed Care Pharmacy. AMCP partnership forum develops steps to strengthen evaluation of digital therapeutics. https://www.prnewswire.com/news-releases/amcp-partnership-forum-develops-steps-to-strengthen-evaluation-of-digital-therapeutics-301371733.html. Published September 8, 2021. Accessed October 18, 2021.