|REN devices review by CHAMP.|
Migraine and cluster headache management is complex, as anyone who lives with these diseases can testify.
What works for one person may not help another, or may even make their attacks worse. Treatments that were previously successful sometimes stop working for no apparent reason. Even if the treatments do help, there may be intolerable side effects or new diagnoses that contraindicate their use.
Increasingly, people are using a toolbox approach to managing both migraine and cluster headache. This multi-modal approach not only makes disease management more patient-centric, but also more holistic. In addition to managing lifestyle factors and having access to acute and preventive medicines, many people with migraine and/or cluster headache could benefit by using one or more of the FDA cleared medical devices. These remote electrical neuromodulation (REN) devices can help block the pain of a migraine or cluster attack, or even prevent attacks from starting – without the side effects that sometimes accompany medications. The toolbox approach to migraine and cluster headache can reduce lost time at work, at school, and with friends and family, and can dramatically improve quality of life.
Unfortunately, many insurance companies are refusing to cover these REN devices. Denials state a variety of reasons, with the most common being that the devices are still “investigational,” even though they have already been cleared by the FDA. The Institute for Patient Access recently published an article highlighting this problem and exploring solutions.
Currently there are a handful of FDA cleared, non-invasive, drug-free devices available. These devices include both preventive and abortive indications, with some cleared for both adult and adolescent use. (Full disclosure: Some of the companies that manufacture these devices are sponsors of CHAMP and CHAMP events.)
Here is an overview of 4 of the REN device options: CEFALY®, gammaCore Sapphire™, Nerivio®, and Relivion®:
CEFALY: An external trigeminal nerve stimulation device, CEFALY sends tiny electrical impulses through a self-adhesive electrode placed on the forehead. This stimulates and desensitizes the trigeminal nerve, reducing the frequency and intensity of migraine attacks. The CEFALY DUAL device is FDA cleared as a migraine abortive as well as for migraine prevention in adults only. Also, it is now available over the counter without a prescription. There is currently an instant rebate offering $100 off the CEFALY DUAL, in addition to a 60-day money back guarantee. For Veterans, the good news is that it is covered by the VA in 165 facilities across the US.
gammaCore Sapphire: By activating the vagus nerve with a gentle, 2-minute electrical stimulation, gammaCore helps block the pain signals that cause migraine and cluster headache attacks. The vagus nerve is known as the body and brain’s superhighway, and plays an important role in regulating pain. Convenient and handheld, this device offers up to 24 stimulations each day. Currently, gammaCore is FDA cleared as a migraine abortive as well as for migraine prevention in both adults and adolescents (12 & older). It is also cleared for use in adults for preventive treatment of cluster headache, and the acute treatment of episodic cluster headache. It is covered by the VA for veterans and active military, and there is a copay assistance program for people who have commercial insurance.
Nerivio: A wireless, smartphone-controlled, wearable device, Nerivio has been FDA cleared as a migraine abortive for both adults and adolescents (12 & older) with episodic or chronic migraine. Nerivio is placed on the upper arm to stimulate peripheral nerves, which signal the brain to alleviate migraine pain. Nerivio can be tried for just $10 for anyone who has insurance coverage, including those with government-funded insurance. Your doctor can prescribe Nerivio by using the Nerivio ProCare form. Some commercial insurance companies have been approving the device for use.
Relivion: The newest device to be FDA cleared, Relivion is a brain neuromodulation system that stimulates both the trigeminal and occipital nerve branches to maximize relief from a migraine attack. The Relivion system can be self-administered with remote physician monitoring capabilities. The system consists of 3 components, the Relivion headset that delivers the stimulation, the patient app that tracks the migraine attacks and treatment, and the Physician Management Interface (PMI) that allows for remote monitoring. Relivion’s cloud based connectivity between the patient app and the PMI is designed to optimize treatment for each attack. While it is currently FDA cleared as a migraine abortive, Relivion is also in clinical trials for a preventive indication. Relivion is expected to have a limited release availability Fall 2021, with full release on the market first quarter 2022. We will keep you updated on its availability. We encourage you to learn more about these REN devices and talk with your doctor to see if they would be good options to add to your treatment toolbox.
Article provided by-The CHAMP Team