Coverage with evidence development study shows benefits in patients with migraine treated with remote electrical neuromodulation.

Objective: Migraine affects millions of individuals in the US, resulting in high health care costs and productivity loss. Traditional medications are often limited in effectiveness and tolerability, creating a need for accessible nonpharmacologic options. This coverage with evidence development (CED) study assessed the necessity of the remote electrical neuromodulation (REN) wearable device for migraine treatment as a standard payer-covered treatment.

Study design: Real-world postmarketing CED study in 2 clinics for 14 months.

Methods: Members (aged 12-75 years) of a major US health insurer (Highmark Inc) diagnosed with migraine were prescribed REN as part of their clinical care. Effectiveness was evaluated by change in Migraine Disability Assessment (MIDAS) score from baseline to 3 months of treatment and by prospective pain and disability reports 2 hours post treatment. Utilization was measured through prescription fulfillment and safety via adverse event reports.

Results: A total of 381 patients (mean [SD] age, 40.5 [13.2] years; 91.1% female) participated. Change in MIDAS score was calculated from all participants who answered the questionnaire twice (n = 116), showing a significant and clinically meaningful mean (SD) improvement of -12.1 (51.8) points (P = .014), from 58.3 (59.0) to 46.2 (44.1). Of the participants, 77.8% reported pain relief and 33.3% reported pain freedom; 70.6% and 50.0% reported relief and freedom from functional disability, respectively. Patients used a mean (SD) of 4.0 (3.1) devices annually (extrapolated). Three minor adverse events were reported. These positive outcomes led to the inclusion of REN as a standard treatment for migraine under Highmark policy.

Conclusions: REN leads to significant clinical and functional benefits in patients with migraine. Additional health insurers are encouraged to consider REN as a standard covered treatment.