Objective: The objective of this study was to evaluate the 2-year effectiveness of the first FDA-authorized prescription digital therapeutic (PDT) for adults with chronic insomnia that delivers evidence-based treatment (Somryst^®). PDTs are software-based disease treatments evaluated for safety and effectiveness in randomized clinical trials, and authorized by the US Food and Drug Administration (FDA) to treat disease with approved directions for use (label).

Methods: A pre/post multi-payer analysis of claims data was conducted, comparing two-year pre- and post-index healthcare resource utilization (HCRU) in an all-comer population of patients with self-identified sleep problems across the United States who activated the PDT between February 1, 2012 and December 31, 2018 (Index). HCRU categories assessed were: hospitalizations, treat-and-release emergency department (ED) visits, ambulatory surgical center (ASC) visits, hospital outpatient department (HOPD) visits, office visits, number of sleep medication prescriptions, and associated health care costs. Costs were estimated by multiplying HCRU by published average costs for each medical resource.

Results: 252 patients initiating the PDT were analyzed (mean age 54.2 years, 57.5% female). Compared to the pre-index period, post-index events were reduced for ED (-56.2%; P=0.001), hospitalizations (-20.9%; P=0.4), sleep medication use (-8.9%; P=0. 0.377), HOPD (-8.3%; P=0.522), and ASC (-6.7%; P=0.695). Post-index events were slightly increased for office visits (+0.7%; P=0.891). Total estimated two-year cost savings associated with the reduced rates of all services except office visits was $494,634, or $1,963 per patient.

Conclusion: In a real-world cohort of patients with self-identified sleep problems, treatment for 9 weeks with a PDT delivering digital CBT-I was associated with clinically meaningful net reductions in health-related services and associated costs with 2-year follow-up.

Disclaimer: On 12/16/21, ISPOR granted permission via email to F. Velez to use the product name Somryst in the abstract, due to a lack of a generic name for the product.