Theranica’s REN Wearable Becomes the First Ever Non-Pharmacological Migraine Treatment to Receive Commercial Coverage in the USA
Feb. 20, 2024: Theranica, a prescribed digital therapeutics company specialising in neuromodulation devices for migraine and other idiopathic pain conditions, announced the inclusion of its Nerivio Remote Electrical Neuromodulation (REN) wearable, for use in the acute and preventive treatment of migraine, under a commercial coverage policy of Highmark Inc (Highmark). This follows the successful completion of its Coverage with Evidence Development (CED) programme with Nerivio, launched in November 2022. The new commercial coverage policy marks a significant advancement in the accessibility of an effective, non-disruptive, and non-pharmacological migraine treatment.
Professor Christopher Gottschalk, MD, FAHS, Neurology Division Chief and Director of the Headache & Facial Pain Center at Yale University and the President of the Alliance for Headache Disorders Advocacy (AHDA), welcomed this coverage policy: “Americans with chronic conditions like migraine have faced a longstanding need for insurance coverage of neuromodulation devices and other non-pharmacological treatments. Nerivio is an evidence-based treatment that is supported by well-controlled trials, and this coverage policy is an encouraging milestone. 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 recognise 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.”
Highmark’s coverage decision for the Nerivio REN wearable follows a rigorous CED study with the device, assessing its clinical benefits over 384 members living with migraine. In the primary endpoint of the study, Nerivio demonstrated statistically significant results in the reduction in Migraine Disability Assessment Score (MIDAS) from 64.0 to 43.9 points (p<0.005). Additional clinically meaningful benefits were demonstrated with 75.8% of the participants experiencing pain relief within 2 hours post-treatment, 37.3% reporting pain freedom, 69.0% indicating functional disability relief, and 52.4% specifying 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. 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.”
Andrea Synowiec, DO, FAAN, Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania, Primary Investigator
