Nerivio Gains Commercial Coverage as Nonpharmacological Treatment for Migraine

According to a recent announcement, Theranica’s remote electrical neuromodulation (REN) device Nerivio, an FDA-approved wearable for acute and preventive migraine, will now be commercially covered under Highmark. With the decision, Nerivio becomes the first ever nonpharmacological migraine treatment to receive commercial coverage in the US.¹

Controlled by a smartphone app and self-administered, the Nerivio REN wearable is a migraine treatment that wraps around the upper arm and uses sub-painful REN to activate nociceptive nerve fibers in the arm. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment. To date, it remains the only FDA-cleared device to utilize REN to prevent and treat migraine.

The decision to provide coverage for the therapy was based on data from a Coverage with Evidence Development (CED) study, which further confirmed its efficacy and safety. Comprised of 384 patients with migraine, Nerivio met its primary end point, with treated patients showing a reduction in Migraine Disability Assessment Score (MIDAS) from 64.0 to 43.9 points (P <.005). In addition, 75.8% of the participants experienced pain relief within 2 hours post-treatment, 37.3% reported pain freedom, 69.0% indicated functional disability relief, and 52.4% specified full return to functional ability post 2 hours.

"The CED study shows statistically significant and clinically meaningful benefits to migraine patients treated with the REN wearable in a real-world environment," lead investigator Andrea Synowiec, DO, FAAN, vice chair of the department of neurology at Allegheny Health Network, said in a statement.¹ "This data highlights the importance of including REN among migraine therapies covered by insurance to address the unmet need for effective, safe, easy-to-use migraine intervention."

Highmark and its Blue-branded affiliates cover the insurance needs of approximately 7 million members in Pennsylvania, Delaware, New York, and West Virginia. Theranica’s Nerivio was originally granted de novo clearance by the FDA in May 2019 for the acute treatment of migraine and was later expanded in October 2020 to include those with chronic migraine.²

A year later, the therapy’s indication was expanded again to include the acute treatment of episodic or chronic migraine in adolescents aged 12 years and older.³ This was significant as most standard-of-acute acute migraine treatments are not approved by the FDA for this age population. Four types of triptans are approved for abortive treatment of migraine in patients in the 12 to 17 years age segment; however, both over-the-counter medications and the migraine-specific triptans have adverse effects, and if taken excessively, may cause medication overuse headache.

"Americans with chronic conditions like migraine have faced a longstanding need for insurance coverage of neuromodulation devices and other non-pharmacological treatments," Christopher Gottschalk, MD, FAHS, neurology division chief and director of the Headache & Facial Pain Center at Yale University, and president of the Alliance for Headache Disorders Advocacy (AHDA), said in a statement.¹ "Nerivio is an evidence-based treatment that is supported by well-controlled trials, and this coverage policy is an encouraging milestone."

He added, "We at the AHDA have high hopes that other US commercial insurers and Federally funded insurance plans will follow the very sensible footsteps of Highmark and recognize the importance of providing the 40 million Americans living with migraine with affordable access to drug-free prescription migraine treatments with clinical benefits properly backed by high-quality data."

In February 2023, Nerivio received FDA approval as a dual-use acute and preventive treatment for migraine with or without aura in patients 12 years of age or older.⁴ The expanded indication was based on results from a randomized placebo-controlled study in which those on Nerivio demonstrated a mean reduction of 4 migraine days per month compared with only 1.3 days for those on placebo. The trial, which featured a 4-week baseline observation phase, followed by an 8-week double-blind period, also showed statistically significant reductions in mean number of headache days of all severities and in the number of days on which patients were required acute migraine medication.

REFERENCES
1. 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 March 18, 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
2. Nerivio receives clearance of expanded indication to cover chronic migraine patients. News release. Theranica. Published October 26, 2020. Accessed March 18, 2024. prnewswire.com/news-releases/nerivio-receives-clearance-of-expanded-indication-to-cover-chronic-migraine-patients-301159445.html
3. FDA approves Theranica’s Nerivio for acute treatment of migraine in adolescents. News release. January 25, 2021. Accessed March 18, 2024. https://www.prnewswire.com/news-releases/fda-approves-theranicas-nerivio-for-acute-treatment-of-migraine-in-adolescents-301213967.html
4. Theranica's Nerivio Cleared by FDA for Preventive Treatment of Migraine. Theranica. News Release. Published February 28, 2023. Accessed March 18, 2024. https://www.prnewswire.com/news-releases/theranicas-nerivio-cleared-by-fda-for-preventive-treatment-of-migraine-301757472.html