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Supplements Noninvasive Vagus Nerve Stimulation for Migraine and Primary Headache Disorders: Efficacy, Cost, and Impact on Quality of Life
Review of Evidence on Noninvasive Vagus Nerve Stimulation for Treatment of Migraine: Efficacy, Safety, and Implications
Mkaya Mwamburi, MD, PhD; Andrew T. Tenaglia, BA; Eric J. Leibler; and Peter S. Staats, MD, MBA
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Noninvasive Vagus Nerve Stimulation in a Primary Care Setting: Effects on Quality of Life and Utilization Measures in Multimorbidity Patients With or Without Primary Headache
Iain Strickland, PhD, BSc; Mkaya Mwamburi, MD, PhD; Steven Davis BSc; James C.R. Ward, MBBS; Janet Day, MBChB; Andrew T. Tenaglia, BA; Eric J. Leibler; and Peter S. Staats, MD, MBA
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Noninvasive Vagus Nerve Stimulation in a Primary Care Setting: Effects on Quality of Life and Utilization Measures in Multimorbidity Patients With or Without Primary Headache

Iain Strickland, PhD, BSc; Mkaya Mwamburi, MD, PhD; Steven Davis BSc; James C.R. Ward, MBBS; Janet Day, MBChB; Andrew T. Tenaglia, BA; Eric J. Leibler; and Peter S. Staats, MD, MBA
Our findings have implications for primary headache indications. The rapid responses observed among both primary headache and nonheadache patients for QOL and healthcare resource utilization measures were similar. This observation aligns with the hypothesis that many primary headache patients, such as those suffering from migraine and cluster headache, have an underlying pathology associated with vagal insufficiency or other latent causation. Patients with migraine and cluster headache seek more medical services (physician and ED visits and laboratory and imaging testing) than the general population, and the average cost of each of these visits and tests cost more for patients with migraine.8 When gammaCore treatment is used, even for primary headache indications, and enhances vagal tone, these multiple comorbidities are improved, resulting in a reduction in healthcare utilization and the cost of care. Both primary headache and nonheadache patients self-identified through symptom relief within 2 to 3 months and uniquely for gammaCore. The lack of response within this period was associated with treatment termination. Nonresponders are identified early and can stop treatment, and associated costs, within 2 months, saving payers unnecessary costs and are considered for cost-saving pay-for-performance insurance coverage policies. Additionally, the significant improvements in QOL is associated with better long-term quality adjusted life years, a key metric for utilities in cost effectiveness analyses as recognized by NICE and payers in the United States and globally. This new evidence demonstrates gammaCore treatment that can save payer costs and reduce future costs. This will be critical in supporting cost-effectiveness analyses and budget impact models for assessing the economic value of gammaCore use in practice and coverage policies, and could form the basis of future practice guides, policy, and research.

The strengths of these analyses are that these are real-world data on persistent gammaCore users and were gathered from patients with no strict or limiting research criteria. The sample size that used gammaCore was reasonable (N = 233), allowing for relevant analyses and inferences to be drawn about gammaCore treatment and were based on statistically significant findings. Multimorbidity MUS patients with and without primary headache diagnoses were included to allow into the unknown latent causation associated with the multiple comorbid conditions. These findings offer new evidence to support future practice guides, policy decisions, and research into the economic benefits of persistent gammaCore use. One of the limitations is the relatively small sample size that may not allow extensive examination of predictors, but nonetheless, provided robust, statistically significant findings.

Conclusions

This evidence suggests that gammaCore may be an effective treatment in functional / MUS multimorbidity patients with or without primary headache that likely suffer from vagal tone insufficiency or a pathology responsive to vagus nerve stimulation. Persistent gammaCore users were high-demand patients with high healthcare resource utilization at baseline who benefited the most with significant reductions in symptoms and utilization. This evidence supports findings of the clinical studies in cluster headache and migraine patients, mode of action models, and the proposition for gammaCore’s value on cost reduction. Further study of the economic impact of gammaCore in a randomized, controlled environment is needed to assess the cost-effectiveness of gammaCore and associated budget impact, if adopted in health insurance coverage policies in multimorbidity patients. 

Author Affiliation: Interface Clinical Services, LTD, Yeadon, Leeds, UK (SD); Werneth Pprimary Care Center, Oldham, UK (JD); electroCore, Inc, Basking Ridge, NJ (EJL, IS, PSS, ATT); profecyINTEL, LLC, Bridgewater, NJ (MM); Oaklands Health Centre, Holmfirm, West Yorkshire (JCRW).
Funding Source: Financial support for this work was provided by electroCore, LLC.
Author Disclosure: Mr Davis reports to board membership, employment, stock ownership, institutional conflicts of interest, being on an advisory board, and giving expert testimony for Interface Clinical Services, LTD. Mr Liebler reports to having employment with electroCore, Inc. Dr Mwamburi reports to serving on an advisory board, receiving a receipt for payment, preparing a manuscript, owning stock, and having employment with profecyINTEL, LLC. Dr Mwamburi also reports to owning stock with Pharmacy Nexus 2017. Dr Staats reports to having board membership with World Institute of Pain (WIP) and serving on an advisory board for Medtronic, Abbott Laboratories, Nalu, and SPA Theraputic. He also reports to having employment with National Spine and Pain Centers and electroCore, Inc. and to attending a meeting or conference at Angas Securities Redeemable Preference, WIP, AMS Technologies AGS. Dr Staats has stock ownership with electroCore, Inc. and d reports a conflict with electroCore, Inc., as it is a a manufacturer of gammacore, a therapy used in headaches. Dr Strickland reports to having employment and stock ownership with electroCore, Inc. Mr Tenaglia reports employment and stock ownership with electroCore, Inc. as it sells gammaCore. Ms Day and Mr Ward reports no relationships or financial interests with any entity that would pose a conflict of interest with the subject matter of this supplement.
Authorship Information: Acquisition of data (IS, JD, JW, MM, SD); administrative, technical, or logistic support (ATT, EJL, IS, SD); analysis and interpretation of data (EJL, IS, JW, MM, SD); concept and design (ATT, EJL, IS, JD, MM, SD); critical revision of the manuscript for important intellectual content (EJL, IS, JD, JW, MM, SD); drafting of the manuscript (ATT, IS, MM, SD); provision of study materials or patients (JD, JW, SD); obtaining funding (ATT, SD); statistical analysis (MM); supervision (IS, SD).
Address correspondence to: mkaya.mwamburi@profecyintel.com; peter.staats@electrocore.com; Andrew.tenaglia@electrocore.com.
 
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