Insurance Coverage for Migraine Preventive Nerivio Expands With DC Medicaid Plan

Author(s):

DC Medicaid covers over 300,000 members in the greater Washington D.C. area, allowing increased access to the FDA-cleared product.

Christopher Gottschalk, MD, FAHS

Theranica has announced that DC Medicaid has been added as the second federally funded insurance plan for Nerivio, an FDA-cleared remote electrical neuromodulation (REN) device. With that, it becomes the first Medicaid plan to cover the wearable migraine therapeutic, offering greater access to beneficiaries in the DC area.¹

Nerivio, a non-drug, non-disruptive treatment for both acute attacks and the prevention of migraine with or without aura, has been on market since 2019. The newly announced coverage expands the potential availability of the therapy to over 300,000 covered members of DC Medicaid in the greater Washington D.C. area, accounting for 45% of the District’s population.

The self-administered treatment, controlled by a smartphone app, wraps around the upper arm and uses sub-painful REN to activate nociceptive nerve fibers in the arm. These fibers send signals that trigger a descending pain management mechanism, ultimately reducing migraine pain and associated symptoms without medication.

"I commend DC Medicaid's decision to cover the Nerivio REN wearable for both acute and preventive treatment of migraines, providing much-needed relief to underserved patients," Christopher Gottschalk, MD, FAHS, general neurology section chief and director of the Headache & Facial Pain Center at Yale University, and immediate past president of the Alliance for Headache Disorders Advocacy, said in a statement.¹ "By embracing clinically proven, non-pharmacologic therapies such as a REN wearable, we're not only improving patient outcomes but also advancing the standard of care for people living with migraine."

As mentioned, this was the second federally funded insurance plan for Nerivio, following the Veteran Affairs (VA) decision to sign a Federal Supply Schedule agreement in February 2021.² Earlier this year, Theranica announced that Nerivio would be commercially covered under Highmark, thus making it the first ever nonpharmacological migraine treatment to receive commercial coverage in the US. Highmark and its Blue-branded affiliates cover the insurance needs of approximately 7 million members in Pennsylvania, Delaware, New York, and West Virginia.³

"This is such great news. Now this treatment can be used as first-line therapy in our young migraine patients with DC Medicaid or managed health plans," Marc DiSabella, DO, director of the Headache Program at Children’s National Hospital in Washington, D.C., said in a statement.¹

A 2023 study published in the Journal of Medical Economics found that coverage of the REN device may significantly reduce disease-burden and save a one-million-member payer plan at least $560 million per year. Following baseline (4-weeks), 248 patients with migraine were randomly assigned to either REN (n = 128) or placebo (n = 120) for 8 weeks and electronically reported migraine symptoms and acute treatments daily.⁴

Of those randomized, 179 (REN: n = 95; placebo: n = 84) qualified for the modified intention-to-treat analysis. Overall, patients on REN had greater outcomes in mean reduction of acute medication days (3.5 [±0.4] vs 1.2 [±0.5]; P = .001) and presenteeism days (2.7 [±0.3] vs 1.1 [±0.4]; P = .001). In addition, mean annual cost-saving for 1 patient using the Nerivio device for migraine prevention estimated $10,000 (±$1777) from reductions in those outcomes, as well as provider visits reduction of 0.09 [±0.1] vs. increase of 0.08 [±0.2]; P = .297) and absenteeism days (0.07 ± 0.1 vs. 0.07 ± 0.2; p = .997), which favored REN but were not significant.

For a plan that covers 56,000 patients with migraine needing preventive treatment, the annual cost-savings was $560.0 million, with the largest direct cost-savings coming from days of acute medications intake. In that category specifically, it constituted a reduction of 2.5 million (±292,000) days of acute medications, translating to an average annual cost-savings of $306.6 million (±35.0 million).

The largest indirect cost-saving came from a reduction in presenteeism, a critical area for employers. There, results showed that using REN prevention leads to a reduction of 35.2 days of presenteeism per patient per year, and 0.91 days of absenteeism per patient per year. Extrapolated over 56,000 employees per year, this constituted a reduction of 1.97 million days of presenteeism in patients who treat with REN prevention relative to their baseline, translating to an average cost-savings of almost quarter billion dollars ($220.8 million [±24.5 million]). Additional sub-analyses showed that the economic benefit related to presenteeism was applicable for any age and for any gender group.

Alon Ironi, chief executive officer at Theranica, added, "A recent report from the Headache and Migraine Policy Forum states that eight in 10 patients say limited access to care leads to more frequent and severe migraine attacks. This underscores Theranica's commitment to providing a non-disruptive and drug-free migraine treatment and also highlights the importance of DC Medicaid's decision to expand access to clinically proven treatments. The in-depth clinical evaluation by Highmark in 2022-2023 has paved the way for DC Medicaid, BCBS North Dakota, and other payers to follow suit and prioritize the well-being of their members living with migraine."¹

REFERENCES
1. DC Medicaid becomes the first Medicaid plan to cover the Nerivio REN wearable, a non-drug treatment for migraine. News release. Theranica. May 21, 2024. Accessed May 23, 2024. https://www.prnewswire.com/news-releases/dc-medicaid-becomes-the-first-medicaid-plan-to-cover-the-nerivio-ren-wearable-a-non-drug-treatment-for-migraine-302150532.html
2. Veterans Affairs (VA) Signs Agreement with Theranica to Make Nerivio® Acute Migraine Therapeutic Device Available to Veterans. News release. February 16, 2021. Accessed May 23, 2024. https://www.prnewswire.com/news-releases/veterans-affairs-va-signs-agreement-with-theranica-to-make-nerivio-acute-migraine-therapeutic-device-available-to-veterans-301228827.html
3. Theranic’s REN wearable becomes the first ever non-pharmacological migraine treatment to receive commercial coverage in the USA. News release. Theranica. February 20, 2024. Accessed May 23, 2024. https://www.prnewswire.com/news-releases/theranicas-ren-wearable-becomes-the-first-ever-non-pharmacological-migraine-treatment-to-receive-commercial-coverage-in-the-usa-302064166.html?tc=eml_cleartime
4. Cowan R, Stark-Inbar Al, Rabany L, et al. Clinical benefits and economic cost-savings of remote electrical neuromodulation (REN) for migraine prevention. Journal of Med Economics. 2023;26(1):656-664. doi:10.1080/13696998.2023.2205751