Reduction in Health Care-Related Costs After Initiation of Treatment With a Prescription Digital Therapeutic for Chronic Insomnia: Two-year Follow up Analysis of Health Care Claims Data

Abstract: Objective: This study evaluated 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 U.S. patients with sleep problems who activated the PDT between 1 June 2016 and 31 October 2018 (Index). HCRU included 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: 248 patients were included (mean age 54.2 years, 57.5% female). Compared to pre-index, post-index events were reduced for ED (-56.2%; P=0.001), hospitalizations (-20.9%; P=0.400), 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 $510,678, or $2,059 per patient. Conclusion: In a real-world cohort of patients with 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.Short Description: This study analyzed healthcare resource utilization 2 years pre-/post-treatment with digital cognitive-behavioral therapy for insomnia (dCBT-I) among an all-comer populations of U.S. patients with sleep problems (n=248). Use of the dCBT-I prescription digital therapeutic was associated with reduced emergency department visits, hospitalizations, sleep medication use, and ambulatory service use. Total estimated 2-year cost savings associated with reduced services was $510,678, or $2,059 per patientName of Sponsoring Organization(s): Pear Therapeutics (US), Inc.