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Supplements Considerations in Non-Invasive Vagus Nerve Stimulation: Clinical Data and Expert Panel Recommendations
Mechanism of Action of Non-Invasive Cervical Vagus Nerve Stimulation for the Treatment of Primary Headaches
Bruce Simon, PhD, and Justyna Blake, MSE
Review of Non-Invasive Vagus Nerve Stimulation (gammaCore): Efficacy, Safety, Potential Impact on Comorbidities, and Economic Burden for Episodic and Chronic Cluster Headache
Mkaya Mwamburi, MD, PhD (HEOR), MA (Econ); Eric J. Liebler, BA; and Andrew T. Tenaglia, BA
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The Emerging Role of gammaCore in the Management of Cluster Headache: Expert Panel Recommendations
Stephen D. Silberstein, MD; Anne H. Calhoun, MD, FAHS; Christina Treppendahl, FNP-BC, AQH; David W. Dodick, MD; Alan M. Rapoport, MD; Avinash Mamidi, PharmD, BCPS; Peter Vargas, RPh; Thomas H. Ebert; Stewart J. Tepper, MD

The Emerging Role of gammaCore in the Management of Cluster Headache: Expert Panel Recommendations

Stephen D. Silberstein, MD; Anne H. Calhoun, MD, FAHS; Christina Treppendahl, FNP-BC, AQH; David W. Dodick, MD; Alan M. Rapoport, MD; Avinash Mamidi, PharmD, BCPS; Peter Vargas, RPh; Thomas H. Ebert; Stewart J. Tepper, MD
Both the ACT1 and ACT2 studies enrolled patients with eCH and cCH. No treatment difference was demonstrated between gammaCore and sham in the cCH cohorts in ACT1 or ACT2.37,45,46 As mentioned above in the ACT1 trial, significantly higher sustained response rates with active versus sham treatment were observed in all subjects and the eCH cohort, but were not observed in the cCH cohort.45 Authors of the study noted that the 15-minute time to first measurement of response, which was composed of an 8-minute nVNS stimulation period followed by a 7-minute period of time, may not have been long enough to demonstrate treatment effects.45 However, in the cCH cohort of the ACT2 study, a higher percentage of attacks achieving pain-free status at 15 minutes was not observed in the gammaCore arm compared with the sham arm (4.8% vs 12.9%, respectively).46 The effectiveness of gammaCore has not been established in the acute treatment of cCH and the device is not approved in the United States for the preventive treatment of CH.44,46 The answer to the question of why the nVNS device is effective in treating acute attacks in some patients with eCH, but is not effective in cCH, is not known and suggests the need for further research into the differences between eCH and cCH.

A late-breaking oral platform presentation at the 59th Annual Scientific Meeting of the AHS in Boston in June 2017 included the results of the pooled analysis of data from ACT1 and ACT2. This analysis evaluated the safety and efficacy of gammaCore as an acute treatment for eCH or cCH in more than 250 patients.47 In ACT1 and the pooled analysis, significantly more patients with eCH achieved mild or no pain at 15 minutes after treatment initiation with gammaCore for the first treated cluster attack (ACT1 primary end point) compared with patients treated with the sham device (34% vs 11%; P = .01, and 39% vs 12%; P <.01, respectively), but not in ACT2 (50% vs 15%; P = .07).47 Additionally, a significantly greater proportion of all treated attacks achieved pain-free status at 15 minutes after treatment initiation (ACT2 primary end point) in eCH patients treated with gammaCore versus sham for ACT1 (15% vs 6%; P <.05), ACT2 (35% vs 7%; P <.05) and the pooled analysis (24% vs 7%; P <.01).47 No significant treatment differences were observed for either of these end points in the total CH population, the cCH population for ACT1, ACT2, or the pooled analysis.47 No serious device AEs were reported.47 Full results of the analysis will be available later this year.

Based on the safety and efficacy in some patients with eCH, the release of gammaCore represents a novel treatment that addresses a large unmet need in this patient population.6 Treatment with gammaCore is not appropriate for all patient groups, and gammaCore is contraindicated in patients who have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device; those who have a diagnosis of carotid atherosclerosis; and in patients who have undergone cervical vagotomy.44 Additionally, the safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is not indicated for: patients <18 years; pregnant women; patients with active cancer or cancer in remission; patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia; patients with an abnormal cervical anatomy; patients with a history of brain tumor; patients with aneurysms; patients who have experienced cerebral bleeding or head trauma; patients with a baseline history of cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure, known severe coronary artery disease or recent myocardial infarction (within 5 years); patients with a history of a prolonged QT interval or arrhythmia; patients with a history of an abnormal baseline electrocardiogram; and patients with a history of seizures.44

Panel Insights and Recommendations

The panel discussed the unmet needs of patients with CH by identifying the benefits and drawbacks of a variety of acute treatments, including subcutaneous sumatriptan, zolmitriptan nasal spray, and oxygen therapy, and provided additional insights based on issues observed among patients under their care.

The panel noted that the evidence and clinical experience that supports the use of high-flow 100% oxygen is significant and the tolerability of the treatment is excellent. Unfortunately, oxygen is often an impractical and nonportable treatment in the acute management of CH, for which treatment is needed immediately after CH attack onset, with the exception of patients who experience nocturnal attacks and who may benefit from home oxygen therapy. Additionally, as noted, the CMS published a policy regarding the use of oxygen for the treatment of CH among Medicare beneficiaries. This policy noted that there is currently insufficient evidence for home use of oxygen to treat CH, and home use of oxygen is only covered for beneficiaries with CH who are participating in an approved prospective clinical study comparing normobaric 100% oxygen with at least 1 clinically appropriate comparator for the treatment of CH.48 At the time of CMS’ publication, no clinical trials involving the home use of oxygen to treat CH had been approved by CMS for Coverage with Evidence Development, resulting in no access to oxygen therapy for the treatment of CH for Medicare and Medicaid beneficiaries.48

Although the AHS treatment guidelines note that there is insufficient evidence that DHE 1 mg nasal spray is effective in improving headache response, in a separate AHS publication, DHE 1 mg intramuscular injection was noted to be effective in the relief of acute attacks of CH, and it is FDA-approved for this purpose.20,49 The panel commented that DHE injections are an effective and sometimes preferred therapy for some healthcare providers and patients; however, DHE injections are also costly, with a WAC of approximately $125 per 1-mg injection.21 The AHS treatment guidelines also include lithium and verapamil as preventive therapies, with a Level C recommendation of possibly effective for the treatment of CH.20 The panel commented that verapamil and lithium have both been prescribed in practice, but both, particularly the latter, have tolerability and safety issues.

Following a review of the data supporting the release of gammaCore, the panel agreed that gammaCore is a safe, well-tolerated, and effective acute treatment option for patients with eCH; it represents a first-line acute treatment option for patients with eCH. The panel referenced supporting literature that highlights the behavioral health disorders associated with CH, including published reports suggesting that patients with CH demonstrate worse working memory, disturbance of mood, and poorer quality of life compared with healthy controls.11 CH is associated with an almost 3 times increased odds ratio of lifetime depression compared with controls, and patients with cCH have a higher prevalence of lifetime depression and sleep disturbance compared with patients with eCH.50 Patients with cCH and eCH experience significant impairments in noneconomic and economic domains (eg, disability, working life, and psychiatric complaints). Psychiatric comorbidity (ie, depressive symptoms, signs of agoraphobia, and suicidal tendencies) is highest in cCH.51 Headache specialist panel participants also reported high rates of opioid and other illicit substance misuse and abuse in patients with CH.

In addition to the comorbid behavioral health conditions associated with CH, the panel noted that there is a major socioeconomic impact on patients and society as a result of both direct and indirect costs caused by lost ability to work.12 As previously mentioned, patients with eCH have extended periods of disability, whereas patients with cCH experience annual periods of remission totaling less than 1 month. The panel stated that the availability of nVNS with gammaCore may offer patients with eCH improved control of attacks, which in turn may result in improvements in quality of life, including the potential to return to work in an increased capacity. Treatment with gammaCore may also offer payers a potential cost savings opportunity if the use of gammaCore results in a reduction in use of rescue medications such as sumatriptan injections or oxygen therapy as demonstrated in the PREVA study.37 All panel participants were in agreement that payers should offer coverage of gammaCore to plan members who have a diagnosis of eCH; these payers would then need to determine whether gammaCore coverage should be provided under the pharmacy or medical benefit.

Future Implications and Considerations

In addition to insights regarding gaps in care and recommendations for payer coverage of gammaCore, the panel noted that additional studies need to be conducted in the United States to verify the role of gammaCore in the preventive therapy of eCH and cCH. Following the review of clinical trials and case series of gammaCore in the United Kingdom, the National Institute of Health and Care Excellence published guidance regarding the use of gammaCore for the prevention and acute treatment of CH and migraine; it noted that gammaCore is safe and can be used in the National Health Service (NHS).52

The use of gammaCore for the prevention and acute treatment of cCH was studied in the PREVA study, which demonstrated medication usage savings of approximately €1736 ($1897 in USD) per patient per year and an average total cost savings of €2799 ($3059 in USD) per patient per year.37,53 Additional future studies conducted in the United States may be helpful in clarifying and identifying additional patient groups (ie, preventive treatment of CH) in which treatment with gammaCore may be beneficial.37,45,46 The savings demonstrated in the model are based on the price of €0.87/dose for nVNS in Germany.54 Investigational treatments in clinical trials, including anti-calcitonin gene-related peptide monoclonal antibodies and sphenopalatine ganglion stimulation, are likely to be more expensive than gammaCore.

The panel also noted that there may be a potential role for gammaCore in the treatment of migraine, and it awaits the results of the ongoing PRESTO and PREMIUM clinical trials evaluating the safety and efficacy of gammaCore for the acute treatment of migraine attacks and the prevention of episodic migraine, respectively.54 Data from these 2 studies are expected later this year.


In conclusion, the panel agreed that the treatment guidelines should be updated to reflect the role of gammaCore as a first-line, acute treatment option for patients with eCH and that payers should offer coverage of gammaCore to their members who have a diagnosis of eCH. Coverage determinations will require decisions to permit coverage under the pharmacy or medical benefit, as well as updates to payers’ pharmacy and/or medical policies to reflect coverage of this novel treatment. Healthcare providers, including headache specialists and neurologists, and payers are encouraged to remain up-to-date regarding the results of ongoing clinical trials evaluating the use of gammaCore for the acute and/or preventive treatment of migraine to ensure that patients are being appropriately treated for these conditions and that they have access to treatment through their insurers.

Author affiliations: Carolina Headache Institute, Durham, North Carolina (AHC); David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California (AMR); Fallon Health, Worcester Massachusetts (THE); Geisel School of Medicine at Dartmouth, Dartmouth, New Hampshire (SJT); Mayo Clinic, Phoenix, Arizona (DWD); Neighborhood Health Plan of Rhode Island, Smithfield, Rhode Island (PV); Sutter Health, Palo Alto, California (AM); The Headache Center, Ridgeland, Mississippi (CT); Thomas Jefferson University, Philadelphia, Pennsylvania (SDS); University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (AHC).

Funding source: This supplement was sponsored by electroCore, LLC.

Author disclosures: Dr Calhoun has disclosed that she has been a consultant, a paid advisory board member, and participated in a research meeting or conference for electroCore, LLC. Dr Dodick has disclosed that he has provided consulting services to the following companies: Acorda Therapeutics, Inc; Allergan, plc; Amgen, Inc; Alder Biopharmaceuticals; Autonomic Technologies, Inc; BioCentric, Inc; Biohaven Pharmaceuticals; Boston Scientific Corporation; Charleston Laboratories, Inc; eNeura Inc; INSYS Therapeutics, Lilly USA, Magellan Health, Inc, Nocira, LLC, Promius Pharma, LLC, Teva Pharmaceuticals Industries Ltd; Trigemina, Inc; Xenon Pharmaceuticals Inc; Zosano Pharma Corp; and Theranica Bio-Electronics. Dr Dodick has also disclosed that he has received royalties from Oxford University Press and Cambridge University Press; he that he has received editorial honoraria from Academy for Continued Healthcare Learning; Chameleon Communications; Global Scientific Communications; Haymarket Medical Education; HealthLogix; Medscape; MeetingLogiX; Miller Medical; UpToDate; WebMD; and Wiley Blackwell. Dr Dodick has also disclosed that he owns stock in Epien Medical, Inc; GBS/Nocira; Healint; and Mobile Health. Dr Dodick also disclosed that he holds board positions at Epien Medical, Inc and King-Devick Technologies, Inc. Dr Ebert has disclosed that he has served as a consultant, on an advisory panel, and attended a meeting or conference for or on behalf of electroCore, Inc. Dr Mamdi has disclosed tha he participated in an advisory board for Magellan Health, Inc. Dr Rapoport has disclosed that he has been a consultant for or participated in a paid advisory board for Acorda Therapeutics, Inc; Amgen, Inc; Autonomic Technologies, Inc; Depomed, Inc; electroCore, LLC; Impax Laboratories, Inc; Pernix Therapeutics Holdings, Inc; Promius Pharma, LLC; Teva Pharmaceutical Industries, Ltd; and Zosano Pharma, Inc. He has also received lecture fees for speaking at the invitation of Avanir Pharmaceuticals, Inc; Depomed, Inc; and Pernix Therapeutics Holdings, Inc. Dr Silberstein has disclosed that as a consultant and/or advisory panel member, he receives, or has received honoraria from Alder Biopharmaceuticals; Allergan, plc, Amgen, Inc; Avanir Pharmaceuticals, Inc; Curelator, Inc; Dr Reddy’s Laboratories Ltd; eNeura Inc; electroCore, LLC; Lily USA, LLC; Medscape, LLC; NINDS; Supernus Pharmaceuticals, Inc; Teva Pharmaceuticals; Theranica Bio-Electronics; and Trigemina, Inc. Dr Tepper has disclosed that he is a member of the board for the American Headache Society and has been a consultant for or participated on a paid advisory board for Acorda Therapeutics, Inc; Alder BioPharmaceuticals, Inc; Allergan plc; Amgen, Inc; Avanir Pharmaceuticals, Inc; BioVision, Inc; Charleston Laboratories, Inc; Dr. Reddy’s Laboratories, Ltd; electroCore, LLC; eNeura, Inc; Eli Lilly and Company; GLG Pharma, LLC; Guidepoint Inc, LLC, Ltd; Kimberly-Clark Corporation; Pernix Therapeutics Holdings, Inc; Pfizer, Inc; Scion NeuroStim, LLC; Teva Pharmaceutical Industries, Ltd; and Zosano Pharma, Corp.  Ms Treppendahl has disclosed that she has received payment for involvement in the preparation of this manuscript, has received honoraria from, and attended meetings or conferences on behalf of electroCore, LLC. Dr Vargas has no relevant financial relationships with commercial interests to disclose.
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