Favorable coverage decision for vagus nerve stimulation in cluster headaches in Norway

Norway has a national framework for introducing new health technologies within the specialist health service, known as the "New Methods" framework. This framework mandates a national or hospital-based health technology assessment (HTA) for all innovations before funding approval.

Since 2021, transcutaneous, non-invasive vagus nerve stimulation (gammaCore) for treating cluster headaches has been under evaluation within the "New Methods" framework. 

In July 2023, the National Institute of Public Health (NIPH) published an HTA concluding that gammaCore may reduce the frequency of attacks and provide faster pain relief. Patients with chronic cluster headaches may benefit most from using gammaCore for attack prevention, while those with episodic cluster headaches have shown documented benefits in the acute phase. The primary analysis indicated that gammaCore, when used alongside standard treatment, was dominant, offering lower costs and greater benefits than standard treatment alone. gammaCore is particularly suitable when standard treatments are ineffective, serving as a step before invasive procedures or lithium. NIPH also calculated budget implications, projecting cost savings due to a reduced need for emergency treatments such as hospitalizations and oxygen therapy.

In January 2025, the Hospital Procurement Health Authority (Sykehusinnkjøp HF) published a price note for gammaCore. On February 10, 2025, the Decision Forum for the "New Methods" framework issued a favorable coverage decision with the following conditions:

• gammaCore is approved for cluster headache treatment;
• Treatment should be discontinued if there is no clinical effect on attack frequency and pain relief after three months;
• The treatment can be implemented immediately, provided necessary agreements between the supplier and health authorities are in place.

See the full details in Norwegian here.

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