Budget Impact of Replacing In-Laboratory Polysomnography With Comprehensive Home Polysomnography Using the Onera Sleep Test System in a U.S. Commercial Health Plan

Background: In-laboratory polysomnography (PSG) remains the diagnostic reference standard for sleep disorders but is resource-intensive and capacity-constrained. Limited-channel home sleep apnea testing (HSAT) improves access and reduces costs compared to in-laboratory polysomnography, but underestimates disease severity due to its inability to measure true sleep time and cannot identify non-respiratory sleep disorders including periodic limb movement disorder and parasomnias.1-5 Comprehensive home polysomnography (hPSG) may preserve diagnostic fidelity while reducing system costs, improving access for patients unable to attend laboratory-based studies, and shortening time to diagnosis and therapy initiation. Objective: To estimate the short-term budget impact to a U.S. commercial health plan of substituting an appropriately selected proportion of in-laboratory PSG with comprehensive hPSG using the Onera Sleep Test System (STS). Methods: We developed a transparent budget impact model following ISPOR good practice guidelines for a hypothetical 1-million-member commercial plan. The model estimates the annual diagnostic population (top-of-funnel) using age- and sex-stratified prevalence, an undiagnosed fraction of 85%, symptom prevalence among undiagnosed individuals (30%), and an annual testing rate (12%).2-3 Baseline costs reflect current diagnostic pathways using HSAT (50% first-line) and in-laboratory PSG (50% first-line), including HSAT-to-PSG escalations (20%) and PSG repeats (4%). The intervention scenario substitutes a defined share of in-laboratory PSG and selected HSAT with Onera hPSG. Scenario and sensitivity analyses explore parameter uncertainty. Results: In the base case, approximately 4,364 individuals entered the OSA diagnostic workflow annually. Baseline diagnostic costs were estimated at $6.23 PMPM, comprising $5.45 million in PSG costs and $0.79 million in HSAT costs. Introducing Onera hPSG (30% PSG replacement, 5% HSAT replacement in Year 1) reduced per member costs to $5.66 PMPM, yielding net savings of $0.57 PMPM ($567,262 annually). In Year 3 scenarios (60% PSG, 10% HSAT replacement), savings increased to $1.64 PMPM (approximately $1.64 million annually). Sensitivity analyses demonstrated net savings ranging from $0.03 to $8.05 PMPM, depending on adoption levels. Conclusions: Partial substitution of in-laboratory PSG with Onera hPSG may yield incremental budget savings for U.S. commercial payers while maintaining access to full polysomnographic assessment. Results support further payer-specific analyses incorporating real-world utilization and downstream outcomes. Keywords: obstructive sleep apnea; polysomnography; home sleep testing; budget impact analysis; health economics