Exploring Digital Therapeutics in Pharmacy and Worker's Compensation
As technology rapidly advances in the medical field, particularly with the integration of artificial intelligence (AI), the significance of digital therapeutics (DTx) and its application in medicine continues to be a subject of exploration. DTx presents a promising pathway for enhancing patient outcomes, cutting costs, and elevating the overall quality of care provided. This article aims to elucidate the concept of DTx, examining its proliferation and influence in pharmacy and worker’s compensation domains. Additionally, we delve into the existing hurdles and prospects of DTx within the healthcare landscape.
Digital Health is the broadest term to refer to health technologies that can share information between people and healthcare providers. These technologies under Digital Health does not need to prove clinical efficacy nor require regulatory approvals, such as telehealth platforms, electronic pill reminders, mobile applications for exercise or diets, just to name a few.
Digital medicine is a narrower scope under Digital Health where products are used to measure or monitor a patient’s health to improve or tailor health care decisions. This includes glucose sensors, digital diagnosis tools, or blood pressure machines that relay that information to an app or portal. Digital medicine does require clinical efficacy but may not require regulatory approval.
DTx is health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health [1]. As such, DTx does require clinical efficacy and regulatory approval. DTx examples include self-care apps that help with mental health disorders or virtual behavioral programs in addiction [2].
Digital Therapeutics in Clinical Practice
The application of DTx is varied and have great potential. Many DTx services revolve around mental/psychiatric/neurological disorders such as migraine, depression, anxiety, insomnia, and post-traumatic stress disorder (PTSD). For example, Freespira is a mobile app and device product in treating panic disorders and PTSD through a breath sensor for CO2 and helping to regulate breathing patterns. There is a video-game based DTx called EndeavorRx for ADHD in children, and a virtual reality DTx, MindMotion™ GO, for neuro rehabilitation [2].
DTx is also available in different chronic disease states such as irritable bowel syndrome, cancer care, asthma/COPD, diabetes, and pain. Some examples are RelieVRx, a virtual reality DTx for the relief of chronic lower back pain, and Insulia or Dario which are mobile applications that can use algorithms to help titrate and optimize insulin dosing [2].
DTx services specifically for worker’s compensation space is small but still developing. In 2022, the FDA granted the Wysa app the Breakthrough Device Designation. The Wysa app is an artificial intelligence (AI)-based conversational agent that delivers cognitive behavioral therapy (CBT) to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function [3]. It was found in a study to be feasible and acceptable for a return-to-work population in worker’s compensation [4]. Although now, there are not many more studies of DTx specifically for the worker’s compensation.
Nevertheless, DTx has the potential to provide personalized care, remote monitoring and support for users in their path to recovery. With many more DTx in the pipeline and in development, the use of technologies for areas like pain can still be viable in the worker’s compensation space.
Challenges and Considerations
While the potential of digital therapeutics in clinical practice is undeniable, several challenges must be addressed to realize their full benefits. Digital therapeutics must comply with regulatory standards and undergo rigorous evaluation to ensure safety, efficacy, and data security. The FDA has a pathway for DTx review and approval, like medical devices and biopharmaceuticals. However, the nature of software devices requires updates or patches post-approval. The framework to follow DTx services in real-world performances is still in the works within the FDA. The integration of DTx into PBMs and other health plans will be a challenge in terms of using the correct coding for reimbursement, claims, the sharing of data in electronic records, and other ways of data exchange. Lastly, access to digital therapeutics may be limited for certain populations, particularly those with limited digital literacy or socioeconomic barriers. Efforts to bridge the digital divide are crucial to ensure equitable access to these interventions.
Conclusion
Digital therapeutics represent a transformative approach to worker rehabilitation within the realm of worker's compensation. By harnessing the power of technology, these innovative solutions offer personalized interventions, remote monitoring, mental health support, and data-driven insights, ultimately enhancing outcomes for injured workers. Embracing digital therapeutics heralds a new era of efficiency, effectiveness, and empowerment in worker's compensation management.
By Monique Bactad, PharmD Candidate
For questions, e-mail pharmd@prodigyrx.com
Citations
[1] “DTA’s Adoption & Interpretation of ISO’s DTx Definition.” Dtxalliance.Org, June 2023, dtxalliance.org/wp-content/uploads/2023/06/DTA_FS_New-DTx-Definition.pdf.
[2] Phan, Philana, et al. “Digital Therapeutics in the clinic.” Bioengineering & Translational Medicine, vol. 8, no. 4, 3 May 2023, https://doi.org/10.1002/btm2.10536.
[3] Baldry, Sarah. “Wysa Receives FDA Breakthrough Device Designation for AI-Led Mental Health Conversational Agent.” Business Wire, 12 May 2022, www.businesswire.com/news/home/20220512005084/en/Wysa-Receives-FDA-Breakthrough-Device-Designation-for-AI-led-Mental-Health-Conversational-Agent.
[4] Iglesias, Marcos et al. “Evaluating a Digital Mental Health Intervention (Wysa) for Workers' Compensation Claimants: Pilot Feasibility Study.” Journal of occupational and environmental medicine vol. 65,2 (2023): e93-e99. doi:10.1097/JOM.0000000000002762
[5] Patel, Nisarg A, and Atul J Butte. “Characteristics and challenges of the clinical pipeline of digital therapeutics.” NPJ digital medicine vol. 3,1 159. 11 Dec. 2020, doi:10.1038/s41746-020-00370-8