Studies on Values of Digital Health

Abstract

Background: The landscape of digital health technologies (DHTs) has evolved significantly, encompassing diverse technologies and platforms. Among these, digital therapeutics (DTx) are software interventions designed to manage diseases and health conditions. Chronic insomnia, characterized by difficulty initiating or maintaining sleep with associated daytime symptoms, affects approximately 8% of adults in the United States (US) and imposes significant burdens on individuals and healthcare systems. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as a first-line treatment, but its utilization is limited due to a shortage of certified providers. Somryst (Nox Health, Alpharetta, GA, US), a US Food and Drug Administration (FDA)-approved DTx, offers an alternative for delivering CBT-I. Objectives: This study aims to evaluate the current landscape of value frameworks for DHTs and DTx through a narrative review, as well as assess the economic impact of Somryst for chronic insomnia management. Methods: A literature search was conducted from September 2023 to January 2024 across multiple databases and websites, focusing on value frameworks for DHTs and DTx. A narrative approach was used to review and summarize findings from selected articles, assessing key elements of identified value frameworks based on previously identified value domains. Additionally, two budget impact analyses were performed over 1-year (primary analysis) and 3-year (secondary analysis) time horizons for (1) the total US population (net budget impact), and (2) a 1-million-member health plan (net budget impact, per-member-per-year (PMPY), per-member-per-month (PMPM)) using Excel. Costs and clinical outcomes associated with Somryst, CBT-I, CBT-I+self-help, and eszopiclone were derived from published literature, Merative Micromedex Red Book, and the Physician Fee Schedule. A scenario analysis using upper limits of probabilities of no-remission was conducted. A decision-tree model was specified to estimate the comparative effectiveness, costs, and cost-utility of the four treatment options. Costs, quality adjusted life years (QALYs), incremental cost-utility ratios (ICURs), and net monetary benefits (NMBs) were estimated. Probabilistic sensitivity analysis (PSA) with 10,000 Monte Carlo simulations was performed to explore uncertainties. Results: The literature search identified six value frameworks: National Health Service (NHS), European Network for Health Technology Assessment (EUnetHTA), Digital Therapeutic Alliance (DTA), World Bank, National Institute for Health and Care Excellence (NICE), and Institute for Clinical and Economic Review (ICER)-Peterson Health Technology Institute (PHTI). These frameworks covered six value domains: technical and security, data rights and governance, clinical characteristics, economic characteristics, health inequalities, and user preferences. The budget impact analysis revealed that the introduction of Somryst resulted in cost savings of $502,712,966 over one year for the total US population. Within a 1-million-member health plan, the introduction of Somryst resulted in cost savings of $1,486,203 (PMPY: -$1.486; PMPM: -$0.124) over one year. The 3-year models estimated net budget impact of $2,802,200,569 for the US population and $7,877,322 (PMPY: -$7.877; PMPM: -$0.656) for a 1-million-member health plan. Scenario analyses revealed a negative budget impact in the first year (US population: -$881,689,604; 1-million-member plan: -$2,606,596; PMPY: -$2.607; PMPM: -$0.217) but indicated added costs in subsequent years, resulting in positive budget impact over three years (US population: $2,679,530,281; 1-million-member plan: $8,250,173; PMPY: $8.250; PMPM: $0.688). Cost-utility analysis showed that costs were highest for eszopiclone ($11,072), followed by Somryst ($5,019), CBT-I+self-help ($4,970), and CBT-I ($4,499). QALYs were similar among the treatments (CBT-I: 0.70; CBT-I+self-help: 0.68; eszopiclone: 0.70) with Somryst having the highest QALY (0.70). In terms of ICURs, CBT-I had an ICUR of -$51,991/QALY lost, CBT-I+self-help had an ICUR of -$1,621/QALY lost, and eszopiclone had an ICUR of $605,338/QALY lost compared to Somryst. Somryst had the highest NMB at $30,622, followed by CBT-I ($30,601) and CBT-I+self-help ($28,825), while eszopiclone had the lowest NMB at $24,118. PSA confirmed Somryst as the most cost-effective treatment for 53.2% of simulations, with CBT-I being the most cost-effective in the remaining 46.8%. Conclusions: Value frameworks for DHTs and DTx coverage on six core value domains serve as comprehensive guides for stakeholders but require further refinement. The economic evaluations suggest that Somryst for chronic insomnia may potentially provide economic benefits while providing a clinically effective treatment option as an alternative to existing chronic insomnia treatments. Clinicians and patients should consider economic implications and patient preferences in treatment decisions. Future research should focus on real-world evidence and standardized willingness-to-pay (WTP) thresholds for DHTs and DTx.