The technology

gammaCore (electroCore) is a handheld, patient-controlled, non-invasive vagus nerve stimulator used for preventing and treating cluster headaches. The device is applied to the neck to deliver a small electric current for 2 minutes at a time. The aim is to modify pain signals by stimulating the vagus nerve through the skin of the neck. gammaCore can be used daily to help prevent cluster headache or when the person feels a cluster headache beginning. The device is small and portable and, after brief training, can be used anywhere that is convenient.

Innovations

gammaCore differs from other vagus nerve stimulators in being applied to the skin of the neck rather than implanted by a surgical procedure.

Current care pathway

NICE interventional procedures guidance on transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine recommends that the procedure should only be used with special arrangements for clinical governance, consent and audit or research. Current evidence on the safety of the procedure raised no concerns but the evidence on efficacy was limited in quantity and quality.

NICE's clinical guideline on headache states that oxygen or triptans should be used for acute treatment of cluster headache. It also recommends that verapamil is prescribed for long-term prophylaxis and that electrocardiogram monitoring may be necessary. Anticonvulsants may also be prescribed. The use of verapamil and anticonvulsants for cluster headache is outside their marketing authorisation.

Specialist commentators have stated that many people with cluster headache do not get enough pain relief from current treatment options, which are often limited by side effects and contraindications.

Population, setting and intended user

gammaCore is intended for use by people with cluster headache for whom standard treatment has been unsuccessful or in people who cannot have other prescribed treatments. If used, it is most likely to be an option before more invasive options or treatment with lithium are considered. Around 66,000 people in the UK experience cluster headache. The company estimate that in about 5% of people with cluster headache, standard care will not work or be unsuitable.

gammaCore is most likely to be started by neurologists in tertiary centres who specialise in headache management. People using gammaCore will need brief training. This is provided by the company at no extra cost. Once trained, people with cluster headache can use gammaCore in any setting.

Costs

Technology costs

The gammaCore device, conductive gel consumables, and first 93-day activation card are initially provided free of charge. This allows the effectiveness of the treatment in individual users to be assessed before further treatment is bought. If the trial is successful, further treatment (through new activation cards) costs £625 for 93 days (exclusive of VAT).

Costs of standard care

Standard care for people with cluster headache includes triptan doses (either as a nasal spray or subcutaneous injection) twice daily to prevent cluster headache and the use of oxygen at home to treat pain during a cluster headache.

Table 1 Cost of standard care to treat cluster headache

Description

Cost

Additional information

Triptan therapy used twice daily, various options available. Costs given for cheapest and most expensive options.

Zolmitriptan 5-mg nasal spray: £36.50.

Sumatriptan 6-mg subcutaneous injections: £40.41 per injection.

Costs from British national formulary (accessed September 2018).

Average monthly cost of oxygen therapy in the home (used with triptan prescription).

£100 (approximately).

Costs provided by company.

This cost is likely to vary depending on use.

Resource consequences

Using gammaCore would add costs to standard care except in cases where it replaced current treatments. There are no published data to determine how likely this is. The extra costs may be offset if it reduced the number or dose of prescribed medicines, or avoided the need for more invasive treatment options.

gammaCore is currently being used in around 20 NHS organisations throughout the UK.

People prescribed gammaCore to treat cluster headache will need brief training which can be given by the company or by specialist clinicians. No changes to the way current services are organised and delivered are expected to be needed.