Early Cost-Effectiveness of SPECTRISTM (Gamma Band Stimulation) in Mild-Moderate Alzheimer's Disease Patients

OBJECTIVES: Alzheimer’s disease (AD) effects over 6.7 million Americans, with a significant burden on patients, caregivers, and providers. Spectris is a non-invasive, at-home treatment intended to slow the progression of AD by evoking gamma frequency oscillations in the brain, which is often disrupted in AD patients, via auditory and visual stimulation. The Phase II randomized controlled trial (RCT), OVERTURE I, showed a 77% reduction in functional decline vs. placebo, with no serious treatment-limiting adverse events. The ongoing pivotal RCT, HOPE, is designed to confirm efficacy and safety of Spectris. Current research evaluates the economic value of Spectris in mild-moderate AD patients in the U.S under various efficacy scenarios.

METHODS: A five-state Markov model characterizing AD progression (mild cognitive impairment [MCI], mild AD, moderate AD, severe AD, and death) was developed to model health-related quality of life (HRQoL) and costs over a lifetime horizon from a payer perspective (costs and QALYs discounted 3%). Spectris was assumed to be used in combination with supportive care (SC). SC transition probabilities, utilities and other cost inputs were identified using published sources. For Spectris, a range of relative risk (RR) efficacy scenarios between 0.3 (consistent with OVERTURE I results) and 0.7 (consistent with available monoclonal antibodies) were applied to SC transition probabilities. Across this range, a cost-effective acquisition cost of Spectris was calculated at a willingness-to-pay (WTP) threshold of $100,000.

RESULTS: Using the previously described efficacy scenarios and a WTP threshold of $100,000/QALY, Spectris would be considered cost effective at an acquisition cost over a range of $108,000 (RR = 0.3) to $44,000 (RR = 0.7). Incremental costs of Spectris were primarily driven by acquisition costs, with background healthcare costs accounting for <1% of costs.

CONCLUSIONS: This early CEM showed that Spectris has the potential to be a cost-effective innovation in AD, with promising efficacy and safety.