Clinical benefits and economic cost-savings of remote electrical neuromodulation (REN) for migraine prevention (NCT04828707)

‍Background

Migraine affects more than 1 billion people worldwide, causing significant disability and substantial clinical economic burden. Remote Electrical Neuromodulation (REN) is a prescribed, wearable, non-pharmacological, non-invasive device (Nerivio), indicated for acute and/or preventive treatment of migraine with or without aura. This study further analyzes clinical benefits from endpoints measured in the clinical trial, as well as their associated direct and indirect costs.

Study aims

Assess the clinical benefits and associated direct and indirect cost-savings following treatment of Remote Electrical Neuromodulation (REN) for migraine prevention.

Methods

Nerivio 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(for 8-weeks) with Nerivio or Sham (placebo) device that looks the same as Nerivio, and electronically reported migraine symptoms and acute treatments daily. Therapeutic-gain was the between-groups difference (Nerivio minus placebo) in change from baseline to the second month of intervention. Health-economics impact was derived as cost-savings associated with Nerivio’s clinical benefits.

Primary endpoints

The following endpoints were examined, testing the mean change from baseline to the second month of intervention in the number of:

• Acute headache/migraine medication days
• headache/migraine related ER visits
• headache/migraine related brain scans
• headache/migraine inpatient admissions
• absenteeism days (number of missed work/school days)
• presenteeism days (number of days with moderate/severe functional disability without absenteeism)

Results

Out of 248 subjects randomized (128 Nerivio:120 placebo), 179 (95 Nerivio:84 Placebo) qualified for modified intention-to-treat (mITT) analysis. Significant therapeutic gains favoring Nerivio vs. placebo were found, including mean (±SD) reduction in number of acute medication days (3.5 ± 0.4 vs. 1.2 ± 0.5; gain = 2.2; p = .001) and presenteeism days (2.7 ± 0.3 vs. 1.1 ± 0.4; gain = 1.6, p = .001). Mean changes of provider visits (reduction of 0.09 ± 0.1 vs. increase of 0.08 ± 0.2; p = .297), and reduction of absenteeism days (0.07 ± 0.1 vs. 0.07 ± 0.2; p = .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 Nerivio 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 (∼$330 million) and indirect costs (∼$230 million) measured.

The following table summarizes the economic benefit for an hypothetical health plan of 1,000,000 covered life with 56,000 of them suffers from migraine.

Change from baselineMean unit costMean monthly cost-savings per patientMean annual cost-savings per patientMean annual cost-savings for a hypothetical plan of one million covered livesChange from baselineAcute medication days−3.5 ± 0.4$120$420 ± 48$5,475 ± 626$306.6 million ± 35.0 millionPresenteeism days−2.7 ± 0.3$112$302 ± 34$3,942 ± 438$220.8 million ± 24.5 millionProvider appointments−0.09 ± 0.1$323$29 ± 32$379 ± 421$21.2 million ± 23.6 millionAbsenteeism days−0.07 ± 0.1$224$16 ± 22$204 ± 292$11.4 million ± 16.4 millionTotal  $767 ± 136$10,000 ± 1,777$560.0 million ± 99.5 million

Table 1 – Calculated economic benefits for 1 million covered life.

Conclusions

Coverage of the Nerivio- (REN-Device) for migraine prevention may significantly reduce disease-burden and save a one-million-member payer plan at least $560 million per year.