. 2025 May 1;25(2):1–177.

Table 32:

Characteristics of Studies Included in the Economic Literature Review

Author, year Country	Study design, analytic technique, time horizon, perspective, discounting	Population	Intervention(s) and comparator(s)	Results
Author, year Country		Population	Intervention(s) and comparator(s)	Health outcomes, mean QALYs per person	Costs, mean total costs per person	Cost-effectiveness
Morris et al, 2016⁸¹ Germany	Study design: CUA Analytic technique: Markov state transition model Time horizon: 1 year Perspective: German statutory insurance (UK perspective as a secondary analysis) Discounting: NA	Adults with chronic cluster headache	Intervention: nVNS (gammaCore) plus standard care Comparator: standard care alone Use of nVNS: prevention Effectiveness data source: PREVA RCT⁵³: gammaCore vs. standard care for 4 wk; then 4 wk of gammaCore plus standard care for all	nVNS plus standard care: 0.607 QALYs Standard care alone: 0.522 QALYs Difference: 0.085 QALYs	Euros(€) Costing year: NR nVNS plus standard care: €7,096.69 Standard care alone: €7,511.35 Difference: -€414.66 Cost of gammaCore €261 (calculated) per gammaCore device; €0.87 per dose (1 device is preloaded with 300 doses)	nVNS was dominant (i.e., less costly and more effective) Probabilistic analysis: nVNS was cost-saving in 80% of simulations Scenario analyses: nVNS was dominant in 3 scenarios that assessed the rate of response loss over time In a scenario assuming a UK payer perspective, the ICER was £166 per QALY
Mwamburi et al, 2017⁸² United States	Study design: CUA Analytic technique: decision-tree model Time horizon: 1 year Perspective: payer (type of payer not identified) Discounting: NA	Adults with episodic cluster headache	Intervention: nVNS (gammaCore) plus standard care Comparator: standard care alone Use of nVNS: acute treatment Effectiveness data source: ACT1 and ACT2 RCTs^51,52: double blind period of 1 mo Model included data related to response in retrained nonresponders; the source of this evidence was unclear	nVNS plus standard care: 0.83 QALYs Standard care alone: 0.74 QALYs Difference: 0.09 QALYs	USD ($) Costing year: 2017 nVNS plus standard care: $9,510 Standard care alone: $10,040 Difference: - $530 Cost of gammaCore: $590 per month	nVNS was dominant (i.e., less costly and more effective) Sensitivity analyses: all 1-way and multiway sensitivity analyses showed that nVNS was cost-effective at a WTP value of $25,000 per QALY The most influential factors were the cost reduction factor with gammaCore; the number of months of prescription per year; and the cost of standard care Probabilistic analysis was conducted, but the CEAC results were not presented
Mwamburi et al, 2018⁸³ United States	Study design: CUA Analytic technique: decision-tree model Time horizon: 1 year Perspective: payer (type of payer not identified) Discounting: NA	Adults with episodic migraine	2 models developed to examine different intervention pathways: Primary model compared nVNS (gammaCore) plus standard care vs. standard care alone Secondary model compared nVNS (gammaCore) plus standard care prior to erenumab prevention vs. no nVNS prior to erenumab prevention (with or without standard care) Use of nVNS: acute treatment Effectiveness data source: PRESTO RCT⁸⁴	Primary model nVNS plus standard care: 0.67 QALYs Standard care alone: 0.63 QALYs Difference: 0.04 QALYs Secondary model nVNS followed by erenumab: 0.70 QALYs Standard care followed by erenumab: 0.67 QALYs Erenumab initiation with no nVNS or standard care: 0.65 QALYs	USD ($) Costing year: NR Primary model nVNS plus standard care: $9,543 Standard care alone: $10,040 Difference: -$557 Secondary model nVNS followed by erenumab: $10,678 Standard care followed by erenumab: $11,583 Erenumab initiation with no nVNS or standard care: $13,766 Difference: -$905 and -$2,183 Cost of gammaCore: $500 per month	Analysis comparing nVNS and standard care alone (primary model): gammaCore was dominant (i.e., less costly and more effective) Probabilistic analysis (primary model): nVNS was cost-effective in more than 95% of simulations at a WTP value of $40,000 per QALY 1-way sensitivity analyses: the most influential factors were the cost reduction factor with gammaCore, the number of months of prescription per year, and the cost of standard care
NICE, 2019³⁰ and supplementary materials^a United Kingdom	Study design: cost analysis Analytic technique: Markov model (manufacturer-submitted economic model) Time horizon: 1 year Perspective: NHS and personal services Discounting: 3.5% for costs	Adults with cluster headache	Intervention: nVNS (gammaCore) plus standard care Comparator: standard care alone Use of nVNS: acute treatment and prevention Data source for effectiveness and cost-effectiveness: PREVA RCT⁵³ and economic model from Morris et al⁸¹	NR	British pounds (£) Costing year: NR gammaCore plus standard care: £3,448.45 Standard care alone: £3,898.86 Difference: -£450.42 Cost of gammaCore: £625 for 93 days of use after a free trial for the first 3 months	gammaCore resulted in cost savings of £450 per patient Sensitivity analysis: highest cost saving of £1,120 and a lowest estimate of -£103 cost incurring Sensitivity analysis: the cost saving depended on the availability of a free trial period and reduced sumatriptan use
Norwegian Institute of Public Health, 2023⁶⁵ Norway	Study design: CUA Analytic technique: Markov model (adapted from Morris et al⁸¹; manufacturer-submitted CUA) Time horizon: 1 year Perspective: Norwegian health care system Discounting: NA	Adults with cluster headache	Intervention: nVNS (gammacore) plus standard care Comparator: standard care alone Use of nVNS: prevention Data source: PREVA RCT⁵³ and economic model from Morris et al⁸¹	mVNS plus standard care: 0.525 QALYs Standard care alone: 0.441 QALYs Difference: 0.085 QALYs	NOK Costing year: NR gammaCore plus standard care: 29,494 NOK Standard care: 32,355 NOK Difference: -2,861 NOK Cost of gammaCore: 5,750 NOK for 93 days of use after a free trial for the first 3 months	gammaCore with standard care was dominant (i.e., less costly and more effective) over standard care alone Sensitivity analysis: gammaCore had a 95% probability of being cost-effective for a WTP value of ≥ 400,000 NOK per QALY

Abbreviations: CEAC, cost-effectiveness acceptability curve; CUA, cost-utility analysis; ICER, incremental cost-effectiveness analysis; NA, not applicable; NHS; National Health Service, NICE, National Institute for Health and Care Excellence; NOK, Norwegian krone; NR, not reported; nVNS; noninvasive vagus nerve stimulation; QALY; quality-adjusted life-year; RCT, randomized controlled trial; WTP, willingness to pay; UK, United Kingdom.

Secondary evidence.