Value Assessment of Prescription Digital Therapeutics

OBJECTIVES: Digital therapeutics (DTx) represent a division of health interventions that are approved by the FDA and are utilized independently or in cohesion with other medical devices or therapies to improve health outcomes. The purpose of the paper is to assess the value DTx renders to various stakeholders of the pharmaceutical industry, including the patients, payors, clinicians and policymakers, while also analyzing the gaps that need to be addressed to expand research in this field.

METHODS: Studies, surveys and review papers analyzing the impact of DTx in different disease states including behavioral disorders, diabetes etc were sought. The US Food and Drugs Administration (FDA) guidelines pertaining to DTx were studied and clinical trial data was retrieved to assess the safety, efficacy and risk of various DTx products. Additionally, industry and company websites were reviewed to characterize the DTx products currently in the clinical pipeline and the disease conditions of interest.

RESULTS: The field of digital therapeutics added value to stakeholders by, 1) Offering engaging experiences to patients through smartphone devices 2) Promoting adherence to treatment by utilizing cognitive or motivational stimulation 3) Providing personalized treatments and goals, 4) Addressing a wide range of under-treated conditions and optimizing patient care by reducing the overall cost of healthcare, 5) Expanding the regulatory guidelines around medical technology. However, there is a need to enhance the outreach of the therapies by factoring socioeconomic status of different patient groups, implementing rigorous quality testing, synthesizing real-world data to assess their impact and developing regulatory programs to incentivize research.

CONCLUSIONS: DTx carries the potential to render significant value to different stakeholders in terms of scalability, increased access to therapy, and reduced costs associated with medical interventions. By addressing the gaps in product penetration and adoption, digital therapies can achieve improved clinical outcomes in an accelerated time frame.