Clinical benefits and economic cost-savings of Remote Electrical Neuromodulation (REN) for migraine prevention.

AIMS Assess the clinical benefits and associated direct and indirect cost-savings from Remote Electrical Neuromodulation (REN) for migraine prevention. METHODS REN, a prescribed, wearable, FDA-cleared neuromodulation-device for the acute and/or treatment of migraine, recently demonstrated efficacy for migraine prevention when used every-other-day, in a prospective, randomized, double-blind, placebo-controlled, multi-center study. Following baseline (4-weeks), subjects underwent treatment with REN (or placebo; 8-weeks), and electronically reported migraine symptoms and acute treatments daily. Therapeutic-gain was the between-groups difference (REN minus placebo) in change from baseline to the second month of intervention. Health-economics impact was derived as cost-savings associated with REN's clinical benefits. RESULTS Out of 248 subjects randomized (128 active, 120 placebo), 179 (95:84) qualified for modifiedintention-to-treat (mITT) analysis. Significant therapeutic gains favoring REN vs placebo were found (Tepper et al., 2023), including mean (±SD) reduction in number of acute medication days (3.4 ± 0.4 vs 1.2 ± 0.5; gain = 2.2; p = 0.001) and presenteeism days (2.7 ± 0.3 vs 1.1 ± 0.4; p = 0.001). Mean changes of provider visits (reduction of 0.09 ± 0.1 vs increase of 0.08 ± 0.2; p = 0.297), and reduction of absenteeism days (0.07 ± 0.1 vs 0.07 ± 0.2; p = 0.997) were not significant. Mean annual cost-saving for one patient using REN for migraine prevention estimated $10,000 (±$1,777) from reductions in these four clinical outcomes relative to baseline without REN treatment. Extrapolated to a hypothetical US commercial health-plan of one-million covered lives, assuming the national prevalence of migraine patients on preventive treatment, annual mean (±SE) cost-saving from using REN migraine prevention estimated $560.0 million (±$99.5 million) from reduction in direct and indirect metrics measured. LIMITATIONS Clinical and cost-savings benefits presented are conservative, assessed only from endpoints measured in the clinical trial. Moreover, some of the endpoints had only scarce or no occurrences during the study period. CONCLUSIONS Demonstrated significant and meaningful clinical, and cost-savings benefits for patients, health insurance systems, and employers, from utilizing REN for migraine prevention.

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