Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia

Felicia Forma,1 Tyler G Knight,2 Frances P Thorndike,1 Xiaorui Xiong,1 Rebecca Baik,2 Fulton F Velez,1 Yuri A Maricich,1 Daniel C Malone3 1Pear Therapeutics, Inc., Medical Affairs Department, Boston, MA, USA; 2Labcorp Drug Development, Market Access Consulting Department, Gaithersburg, MD, USA; 3Strategic Therapeutics, LLC, Oro Valley, AZ, USACorrespondence: Felicia Forma, Pear Therapeutics, Medical Affairs Department, 200 State St, Boston, MA, 02109, USA, Email felicia.forma@peartherapeutics.comBackground and Objectives: This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I).Methods: Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018.Results: A total of 248 patients were analyzed (median age 56.5 years, 57.3% female, mean ISI score 19.13, 52.4% treated with sleep aid medications pre-index). After 9 weeks, mean ISI score declined by 37.2% from baseline (19.1 vs 12.0), 58.8% of patients achieved ISI responder status (ISI score improved by => 7; NNT: 1.7), and 26.6% of patients achieved insomnia remission (ISI score < 8; NNT for remission: 3.8). After two-year follow-up, post-index events were reduced (compared to 2 years pre-index) for emergency department visits (− 53%; IRR: 0.47; 95% CI 0.27, 0.82; P=0.008), hospiatizations (-21%; IRR: 0.79; 95% CI 0.46, 1.35; P=0.389) and hospital outpatient visits (− 13%; IRR: 0.87; 95% CI 0.66, 1.14; P=0.315). Slightly increased rates were observed for ambulatory surgical center visits (2%; IRR: 1.02; 95% CI 0.73, 1.44; P=0.903) and office visits (2%; IRR: 1.02; 95% CI 0.92, 1.14; P=0.672). The number of patients treated with sleep aid medications dropped 18.5% (52.4% pre-index vs 42.7% post-index). Average number of prescriptions decreased from 3.98 pre-index to 3.73 post-index (P= 0.552). Total two-year cost reduction post-index vs pre-index was $510,678, or -$2059 per patient.Conclusion: In a real-world cohort of patients with chronic insomnia, treatment with a digital therapeutic delivering CBT-I was associated with reductions in insomnia severity, emergency department visits, and net costs.Keywords: CBT-I, cognitive behavioral therapy for insomnia, chronic insomnia, prescription digital therapeutic, SHUTi, Somryst