0711 Health-Economic Implications of Tonic Motor Activation (TOMAC) therapy for RLS: An Exploratory Analysis based on the RESTFUL study

Abstract Introduction Restless legs syndrome (RLS) is a debilitating condition associated with reduced health-related quality of life (HRQoL) and increased resource utilization. Recently, the RESTFUL study demonstrated significant improvement in RLS severity following treatment novel non-invasive neuromodulation (Tonic Motor Activation; TOMAC). Our objective was to provide model-based estimates quality-adjusted year (QALY) gain reduction healthcare utilization that might be expected for observed changes symptom severity. Methods The randomized n=133 subjects 1:1 active TOMAC sham control, change International Legs Scale (IRLS) scores reported at four weeks end randomization period. Functional relationships between IRLS HRQoL were derived from two prior health-economic studies (Happe et al. 2009 Durgin 2015). Model-projected events avoided five-year analysis horizon calculated based on assumption maintained effect. Results From baseline 25.2, -7.2 -3.8 group (between difference -3.4, p< 0.01). Based this effect size, projected add 0.16 QALYs over 5 years (0.39 when considering baseline). lower severity, avoid 3.80 (8.05) health care provider visits, 0.29 (0.62) ER 0.12 (0.26) hospitalizations years, resulting relative risk (RR) composite 0.94 (0.88). Conclusion findings exploratory suggest TOMAC-associated improvements as may lead meaningful patient quality-of-life concurrent reductions Further investigation warranted. Support (if any) Wing Tech Inc. (AMR, KNC, JBP) received consulting fees Noctrix Health. AR an investigator study.