Authors' objectives: The aim of this single technology assessment is to assess effect, safety and health economics based on the submitted documentation from electroCore, the manufacturer of gammaCore.

Authors' results and conclusions: 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 gammaCore’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 gamma-Core 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.

Authors' methods: This report is based on an evaluation of the documentation provided by the submitter. The submission file states that the following databases were searched for clinical trials on the 30. March 2022: Medline, Embase, Medline (R) In-Process, and Cochrane Library. ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) were searched for ongoing or unpublished studies. Searches were meant to update the searches reported in a submission file to the National Institute for Health and Care Excellence (NICE) from 2019.

Project Status: Completed

Year Published: 2023

URL for published report: https://www.fhi.no/en/publ/2023/Transcutaneous-non-invasive-vagus-nerve-stimulation-gammaCore-for-the-treatment-of-cluster-headache/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo