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

Abstract

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