This analysis examined the impact of a digital therapeutic for treating chronic insomnia (currently marketed as Somryst®, at the time called Sleep Healthy Using The internet [SHUTi]) on healthcare resource use (HCRU) by comparing patients treated with the digital cognitive behavioral therapy for insomnia (dCBTi) to patients not treated with dCBTi, but with insomnia medications.

A retrospective observational study using health claims data was conducted in two cohorts across the United States: patients who registered for dCBTi (cases) between June 1, 2016 and October 31, 2018 (index date) vs. patients who did not register for dCBTi but initiated a second prescription for an insomnia medication in the same time period (controls). Observation period was 16–24 months. No other inclusion/exclusion criteria were used. Control patients were matched using a nearest neighbor within-caliper matching without replacement approach. Incidence rates for HCRU encounter type were calculated using a negative binomial model for both cohorts. Costs were estimated by multiplying HCRU by published average costs for each medical resource.

Evaluated were 248 cases (median age 56.5 years, 57.3% female, 52.4% treated with sleep-related medications) and 248 matched controls (median age 55.0 years, 56.0% female, 100.0% treated with sleep-related medications). Over the course of 24 months post-initiation, cases had significantly lower incidences of inpatient stays (55% lower, IRR: 0.45; 95% CI: 0.28–0.73; P=0.001), significantly fewer emergency department (ED) visits without inpatient admission (59% lower; IRR: 0.41; 95% CI: 0.27–0.63; P<0.001), and significantly fewer hospital outpatient visits (36% lower; IRR: 0.64; 95% CI: 0.49–0.82; P<0.001). There was also a trend for fewer ambulatory surgical center visits (23% lower; IRR: 0.77; 95% CI: 0.52–1.14; P=0.197) and fewer office visits (7% lower; IRR: 0.93; 95% CI: 0.81–1.07; P=0.302) with the use of SHUTi. Use of sleep medications was more than four times greater in controls vs. cases, with 9.6 (95% CI: 7.88–11.76) and 2.4 (95% CI: 1.91–2.95) prescriptions/patient, respectively (P<0.001). All-cause per-patient HCRU costs were $8,202 lower over 24 months for cases vs. controls, driven primarily by a lower incidence of hospitalizations (-$4,996 per patient) and hospital outpatient visits (-$2,003 per patient).

Patients with chronic insomnia who used a digital CBTi treatment had significant and durable real-world reductions in hospital inpatient stays, ED visits, hospital outpatient visits, and office visits compared to matched controls treated with medications.

Pear Therapeutics (US), Inc.

Chronic insomnia affects the physical and mental health, quality of life, and productivity of 6 to 10% of the adult population (15-25 million U.S. adults). Available treatments include guideline-recommended first-line cognitive behavioral therapy for insomnia (CBT-I) and medications. However, limitations such as patient access to CBT-I and limited efficacy, the presence of significant side effects, as well as safety concerns about medications limit favorable outcomes. Somryst is an FDA-authorized prescription digital therapeutic for the treatment of chronic insomnia in adults. The purpose of this analysis is to compare the effectiveness of the digital therapeutic vs CBT-I and medications for primary insomnia.

Chronic insomnia trials focused on digital therapeutic, CBT-I, or medication were identified in a systematic literature review. Studies using a comparator arm that cannot be considered clinically equivalent to other treatments in the network were excluded (eg, meaningfully different definition of placebo arm). A Bayesian network meta-analysis was performed in R on the mean change from baseline and the proportion of remitters using the insomnia severity index (ISI) endpoint with follow-up timepoints between 6 and 12 weeks. Mean change in ISI score from baseline was analyzed as a continuous endpoint while comparisons of the proportion of remitters were performed using odds ratios. The analysis used a random-effects model for the base case analysis. A surface under the cumulative ranking curve (SUCRA) analysis was performed to rank the treatments on each endpoint.

In total, 13 studies reported ISI mean change from baseline data. Only the digital therapeutic and CBT-I were significantly different than placebo. The digital therapeutic had the greatest mean change from baseline in ISI from placebo (−5.77 points, 95% Credible Interval (CrI) [−8.53, −3.07]), followed by CBT-I (−4.3 points, 95% CrI [−6.32, −2.39]). In the SUCRA analysis, the digital therapeutic had the highest probability (56%) of being the most effective treatment based on ISI mean change from baseline. Only 8 studies reported the proportion of ISI remitters. Only the digital therapeutic showed a statistically significant difference in remission vs placebo and had the highest odds ratio for remission vs placebo (12.33 95% CrI [2.28, 155.91]). The odds ratio for remission vs placebo in CBT-I was not statistically significant (4.08 95% CrI [0.45, 45.58]). The digital therapeutic had the highest probability (64%) of being the most efficacious for inducing remission per ISI.

Somryst was projected to be the most effective therapy on both mean change in ISI and ISI remission within 6 to 12 weeks of treatment start vs either CBT-I or medications. Further investigation should be performed to demonstrate the long-term effectiveness of all chronic insomnia treatments.

Pear Therapeutics

Psychiatric prescribers typically assess adherence by patient or caregiver self-report. A new digital medicine (DM) technology provides objective data on adherence by using an ingestible event monitoring (IEM) sensor embedded within oral medication to track ingestion. Despite likely clinical benefit, adoption by prescribers will in part depend on attitudes toward and experience with digital health technology, learning style preference (LSP), and how the technology s utility and value are described.

is to identify attitudes, experiences, and proclivities toward DM platforms that may affect adoption of the IEM platform and provide direction on tailoring educational materials to maximize adoption. Methods A survey of prescribers treating seriously mentally ill patients was conducted to assess drivers/barriers to IEM adoption. Factor analysis was performed on 13 items representing prior experience with and attitudes toward DM. Factor scores were correlated with prescriber characteristics including attitude and experience with digital technologies, LSP, and level of focus on healthcare cost.

A total of 127 prescribers (56% female, 76% physicians, mean age 48.1yrs.) completed the survey. Over 90% agreed medication adherence is important, visits allow enough time to monitor adherence (84.1%), and tailoring treatment to level of adherence would be beneficial (92.9%). The majority (65.9%) preferred relying upon outcomes data as their learning style while 15.9% preferred opinion leader recommendations and 18.3% information about how the technology would affect practice efficiency. Factor analysis revealed four dimensions: Level of comfort with EHR; Concern over current ability to monitor medication adherence; Attitudes about value of DM applications; and Benefits vs cost of DM for payers. Women scored higher on attitudes about the value of digital applications (p<0.01). Providers who perceive non-adherence as costly, and those who believe DM could benefit providers and patients scored higher on the value of DM (p<.05). Those whose LSP focuses on improving efficiency and prescribers with a higher proportion of Medicaid/ uninsured patients displayed concern about their ability to monitor adherence (p<0.05). Willingness to be a Beta Test site for DM applications was positively correlated with concern about their ability to monitor adherence and attitudes about the value of DM (p <0.01).

Prescriber characteristics including LSP, focus on healthcare costs, and attitudes toward DM may be related to adoption of the IEM platform. Those with more Medicaid/ uninsured patients were more concerned about ability to monitor adherence while those focused-on cost and benefit to providers and patients viewed DM as part of a solution for managing outcomes and cost. Overall, LSP, patient panel size by payer type, and focus on healthcare cost containment should be considered when developing IEM provider training materials.

Otsuka Pharmaceutical Development & Commercialization, Inc.