Cost-Effectiveness of Tonic Motor Activation (TOMAC) Therapy for Patients with Restless Legs Syndrome: An Exploratory Analysis.

Introduction: Tonic motor activation (TOMAC) therapy is a novel non-pharmacologic treatment approach for patients suffering from medication-refractory restless legs syndrome (RLS). The objective of this study was to explore the potential cost-effectiveness of TOMAC in the US healthcare system.

Methods: A decision-analytic Markov model was constructed to project strategy-specific treatment costs and benefits over 3 years and lifetime. Cohort characteristics (mean age 57.4 years, 39.8% male) and treatment effects were derived from the sham-controlled RESTFUL study. Study-observed International RLS Study Group (IRLS) scores were used to estimate changes in healthcare resource utilization and quality of life based on mapping algorithms informed by published data. The incremental cost-effectiveness ratio (ICER) was evaluated against established willingness-to-pay thresholds of $50,000/$150,000 per QALY to determine cost-effectiveness. Extensive scenario analyses were performed, including longer-term extension study data.

Results:  TOMAC and sham reduced IRLS scores from baseline 25.3 to 18.10 and 21.60, respectively, at 4 weeks (treatment effect - 3.4 vs. sham), with an increase in utility from 0.80 to 0.84 (0.75-0.84 vs. baseline). Over 3 years and lifetime, the TOMAC vs. sham effect size corresponded to an added 0.10 and 0.49 QALYs (2.36 vs. 2.26; 12.59 vs. 12.10) at incremental costs of $8061 and $36,373 ($36,707 vs. $28,646; $224,040 vs.$187,667), resulting in ICER estimates of $83,822 and $73,600, respectively. Compared to baseline, TOMAC resulted in ICER estimates of $29,569 and $23,690 over 3 years and lifetime, respectively. TOMAC remained cost-effective or dominant across all scenarios, with ICERs ranging from $10,530-$83,822 and - $8061 to $29,569 vs. sham and baseline, respectively. Larger TOMAC effect sizes, achieved per extension study data, further increased cost-effectiveness.

Conclusion:  Based on this exploratory analysis of published trial data, TOMAC therapy appears to offer meaningful improvements in patient health-related quality at net costs that render it a cost-effective intervention. Further analyses are warranted.