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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
A patient audit was conducted in the UK to evaluate the impact of gammaCore use in multimorbidity patients on quality of life and healthcare resources utilization measures. A total of 233 patients were enrolled and their data was examined over a 1-year period after their gammaCore prescription. Of these patients, 132 (56%) had primary headache disorders while 101 (44%) were patients without a headache disorder (nonheadache patients). The mean age was 49 years, 169 (72%) were female, the mean number of comorbid conditions was 3.1, and the mean baseline EQ-5D score was 0.581. The mean paired difference in EQ-5D index for persistent gammaCore users (ie patients who used gammaCore for at least 40 weeks) was +0.156 at week 40. The mean percentage reductions in number of general practice consults (doctor’s office appointments) was –28.5% from baseline mean of 7.31 and, 40.0% from baseline mean of 3.52 for medical codes used. This evidence demonstrates that a significant proportion of these multimorbidity patients on gammaCore remained compliant with the prescribed treatment regimen for an extended period. GammaCore use in multi-morbidity patients may be associated with lower costs of care and provide opportunities for pay-for-performance coverage policies.
Am J Manag Care. 2018;24:-S0
The FDA cleared gammaCore (noninvasive vagus nerve stimulator, nVNS; electroCore Medical, LLC, Basking Ridge, NJ) for treatment of episodic cluster headache in 2017 and for the acute treatment of migraine in January 2018.1,2 GammaCore also has 5 Conformité Européenne (CE) marks for primary headache disorders, bronchoconstriction, epilepsy, gastric motility disorders, depression, and anxiety. These are symptoms associated with medically unexplained symptoms (MUS) in adults.3,4 GammaCore has shown efficacy in numerous pilot and double-blind, sham-controlled studies in episodic cluster headache and episodic migraine populations. The device is safe, practical, and convenient.5,6 Patients with primary headache disorders have associated multiple comorbidities at a higher rate than those without headache disorders. Their overall medical costs are between 2 and 3 times the average patient without headaches.7-9 Guidelines published by The National Institute for Health and Care Excellence (NICE) describe the need to optimize care of patients with multiple comorbid conditions to improve patient quality of life (QOL) and reduce healthcare utilization.10 In the United Kingdom (UK), approximately 25% of all general practice (GP) consults (doctor’s office appointments), and 25% of all hospital referrals (to specialists) are generated by 10% of the adult population with MUS or “functional disorders.”10,11 These patients typically suffer from 3 or more concurrent illnesses falling into the following categories: primary headache disorders, gastric motility disorders, anxiety, depression, and widespread chronic pain.11 GammaCore may have the potential to treat multiple MUS symptoms.12-14 We conducted an audit of patients with multiple symptoms who were prescribed gammaCore and their data examined for up to 1 year, documenting their experiences, QOL, and healthcare utilization measures, including EQ-5D index, GP consults, referrals, diagnosis codes, and need for sick notes. The aim of this audit was to evaluate the impact of gammaCore use in the real-world primary care setting.

Methods

An audit of medical records of patients who were invited to participate and subsequently prescribed gammaCore for multimorbidity disorders in the UK was conducted.

Patient Population and Exclusion Criteria

Seven primary care practices in northern UK participated. Eligible patients were adults aged 18 to 70 years diagnosed with and coded for 2 or more of the following conditions: primary headache; gastric motility disorders; anxiety and depression; chronic pain; sino-bronchial symptoms; tinnitus; epilepsy; and insomnia. Eligible individuals were identified and invited to participate via physical mail requests. Patients were excluded if they had metallic implants, including but not limited to stents, bone plates, or bone screws, at or near the treatment site; an active implantable medical device, such as a pacemakers, defibrillators, cochlear implants, and other implanted electronic devices; and a history of significant carotid atherosclerosis; cervical vagotomy. Also excluded were pregnant women (women were advised to discontinue treatment if they became pregnant during the course of the observation period); patients with active cancer or cancer in remission; and patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia.

Definitions

The following definitions are used in the context of this publication: gammaCore refers to the use of a proprietary externally applied device that stimulates the vagus nerve noninvasively (transcutaneously); gammaCore dose refers to 2 stimulations of gammaCore (nVNS) administered bilaterally (one on each side). Patients used 3 doses a day; persistent gammaCore users refer to patients who were prescribed and adhered to gammaCore regimen consistently for at least 40 weeks (n = 61); QOL measures refer to EQ-5D index; healthcare resources utilization measures (or “utilization”), refers to numbers of GP consults, referrals and diagnosis codes used; productivity measures refers to number of sick notes issued; last observation carried forward (LOCF) analysis refers to longitudinal analysis of all  patients (n = 233) qualified to participate in the audit (given device and attended 2 in-person visits at baseline and at 4 weeks) comparing QOL, utilization, and productivity measures of the last observed visit up to week 40 to baseline; and persistent gammaCore user analysis refers to longitudinal analysis of only the patients meeting the persistent gammaCore users definition above (n = 61) comparing QOL, utilization, and productivity measures at week 40 to baseline.

Approach

All eligible patients were invited by mail to present to participating clinics. After explanations on procedures and providing informed consent, patients willing to use gammaCore as an adjunct to their current treatment regimens were prescribed and trained to use gammaCore, given the device to take home, and advised to administer a stimulation bilaterally for 3 times a day for a total of 6 stimulations in 12 minutes. Participating patients completed a health-related QOL (EQ-5D-5L) questionnaire at baseline. A second in-person clinic visit 4 weeks after baseline while on gammaCore was required to complete eligibility. During the second visit, stimulation technique was verified and corrected accordingly, adherence to therapy was assessed, and an opportunity to address any questions that patients may have was given. Details of GP consults, referrals, diagnosis codes used during provider engagements, and sick notes issued were collected from patient records. Patients completed the EQ-5D-5L questionnaire every 4 weeks. Changes in QOL, utilizations, and productivity measures were calculated by comparing EQ-5D entries, numbers of GP consults, referrals, diagnosis codes used, and sick notes issued during the last 4-week observation interval and baseline 4-week interval.

Statistical Analyses

Descriptive statistics were used to compare patient reported health outcomes before and after gammaCore use. Means (standard deviation) and frequency (percentage) were used to characterize continuous variables and binary/categorical variables respectively for baseline characteristics. Paired differences of the EQ-5D index, EQ-5D individual components, number of GP consults, referrals, diagnosis codes used, and sick notes issued were calculated using paired T-test for LOCF analyses (n = 233) and persistent gammaCore user analyses (n = 61) as defined previously in this paper. Statistical significance for the paired t-test was set at P <.05. Analyses were performed for all patients as well as sub-group analyses for patients with primary headache diagnosis (n = 132 for LOCF analysis and n = 37 for persistent gammaCore user analysis) and nonheadache patients (n = 101 for LOCF analysis and n = 24 for persistent gammaCore user analysis). No formal comparisons were made between the primary headache and nonheadache patient subgroups.

Results

Patient Attrition

A total of 2206 mail invitations were sent to potential participants that were identified via chart review as adults diagnosed with 2 or more disorders of interest. Of these, 422 (19.1%) patients attended the first clinic visit, with 354 (83.9%) of these patients being eligible to participate and prescribed gammaCore therapy. Of the 354 patients, 233 (65.8%) attended the second (at week 4) in-person clinic visit while on gammaCore and were included. At week 8 and week 40 after initiating gammaCore, 201 (86.3%) and 93 (39.9%)  patients remained on gammaCore treatment, respectively, and 145 (62.2%) and 61 (26.2%) patients reported their EQ-5D-5L outcomes, respectively, with 134 (58%) patients continuing therapy beyond 6 months.15 Patient attrition is illustrated in Figures 1a and 1b for procedures and gammaCore use, respectively.

Baseline Characteristics

At the time of their baseline evaluation (n = 233), the mean age was 49 years, 169 (72%) were female and 132 (56%) were multimorbidity patients that included a primary headache diagnosis code, while 101 (44%) did not include any primary headache diagnosis (nonheadache patients). Of the 233 patients, 83% had anxiety or depression, 47% had gastric motility disorders, 39% had chronic pain, 52% had sino-bronchial symptoms, 21% had insomnia, and fewer than 10% had tinnitus and epilepsy. The mean number of comorbid conditions was 3.1, with 78 (33%) patients having 1 to 2 comorbid conditions, 130 (56%) having 3 to 4 comorbid conditions, and 25 (11%) having 5 or more comorbid conditions. The mean baseline EQ-5D index for all patients was 0.581, and the total mean number of consults, referrals, codes used, and sick note requests between baseline and week 4 visits together with other patient baseline characteristics for primary headache, nonheadache, and all patients are shown in Table 1.

GammaCore Adherence and EQ-5D Index Trends

 
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