Transcutaneous non-invasive vagus nerve stimulation (gammaCore) for the treatment of cluster headache: A single technology assessment

Cluster headache is a relatively rare but extremely painful condition. It is part of a group of conditions known as trigeminal autonomic cephalalgias (TACs). Cluster headache involves recurrent attacks of severe, unilateral pain. Attacks occur in periods (clusters) of several weeks and may last from 15 to 180 minutes at a rate of one every other day to eight per day. GammaCore is a handheld medical device stimulating the vagus nerve with electrical impulses. According to the submitter, gammaCore can reduce the need for acute treatment with oxygen or triptans associated with attacks. Effectiveness and safety: One study comparing gammaCore to standard treatment shows that prophylactic use of gammaCore may improve quality of life, reduce attack frequency, and reduce the use of abortive medication among patients with chronic cluster headache. Two studies comparing gammaCore versus sham in the treatment of ongoing attacks show that gammaCore may have limited impact on patients with chronic cluster headache, but patients with episodic cluster headache probably experience higher likelihood of achieving pain-free status at 15 min and reduced pain intensity. The included studies reported few adverse events, and no serious adverse events have been reported since the introduction on the European market. However, the manufacturer warns that gamma- Core’s safety and efficacy has not been evaluated for patients with cardiological disorders. Severity: Absolute shortfall for patients with chronic cluster headache is 7.03 QALYs. The figure for patients with episodic cluster headache has not been estimated but is likely to be somewhat lower. Economic analysis: Based on the submitters economic model gammaCore plus standard of care are dominant over standard of care alone, i.e. the costs are lower and the benefits are higher. The submitted budget impact analysis estimates that the number of patients using gammaCore will grow from 0 to 325 over the next five years if gammaCore is adopted, resulting in a cost saving of NOK 7,140,000 at year five. NIPH considers the economic analysis to be reasonable for patients with chronic cluster headache, but there are important uncertainties with respect to its relevance for those with episodic cluster headache.