ARTICLE IN BRIEF
Migraine experts discuss and compared three devices the FDA approved for treatment or prevention of migraine.
Three devices are approved by the US Food and Drug Administration (FDA) for treatment of acute migraine pain. But how they each compare, and which devices clinicians recommend are as much dictated by patients' preferences as they are by their effectiveness, migraine specialists told Neurology Today.
The latest device, the gammaCore noninvasive vagus nerve stimulator (nVNS), was approved by the FDA on January 29, expanding market approval of the first self-administered transcutaneous vagus nerve stimulator for acute treatment of migraine pain. The agency approved the device for episodic cluster headaches last April.
The nVNS is the third prescription external neuromodulation migraine device to receive approval, and the FDA categorizes all of them as low-risk.
The FDA based its approval on findings from the Prospective Study of nVNS for the Acute Treatment of Migraine (PRESTO) trial, a sham-controlled, double-blind, randomized study conducted in 243 patients with episodic migraine.
At the Congress of the International Headache Society meeting in Vancouver, Canada, in last September, PRESTO researchers reported that, compared to treatment with a sham device, the nVNS provided significantly better migraine pain relief at 30 and 60 minutes, and, after ad hoc analysis, at 120 minutes. At 30 minutes it provided three times better freedom from pain, and two times better relief at 60 minutes. [See “Pivotal Studies: Migraine Devices” for a summary of the PRESTO trial and other studies that led to approval of the other approved devices.]
“The PRESTO trial is the largest randomized, double-blind, sham-controlled study of a non-invasive neuromodulation device for the acute treatment of migraine,” said trial research coordinator Christine Tassorelli, MD, PhD, director of the Headache Science Center at the C. Mondino National Neurological Institute, in Pavia, Italy.
“The pain-free responder rate at two hours in the treatment group was consistent with the rate generally seen in previous studies evaluating the efficacy of oral triptans and potent nonsteroidal anti-inflammatory drugs,” Dr. Tassorelli said. “There were very few side effects, and the fact that the patient can use this device at their own convenience, with no drug-like side effects, makes it an attractive alternative for the acute treatment of migraine,” she told Neurology Today.
All of the devices are only available by prescription, and coverage by health insurers differs for each device and individual coverage.
The nVNS (manufactured by electroCore) has only been approved for acute use, not for preventing migraine. It is a hand-held unit about the size of an electric razor that a patient holds to the side of their neck. Each stimulation lasts for two minutes and the patient may control its intensity. Stimulation should be applied to each side of the neck, Dr. Tassorelli said, and can be repeated once, 20 minutes later, if the pain has not lessened, and again after two hours for further pain relief.
The unit is only available as a rental and needs to be replaced every 31 days. The out-of-pocket cost is $598 a month without insurance, but the company offers a $100 “co-pay assistance” reduction.
The Cerene/Spring mini transcranial magnetic stimulator (TMS), manufactured by eNeura Therapeutics, is a self-administered, hand-held device that delivers a brief single pulse of magnetic energy to the back of the head to induce an electrical current in the occipital cortex. The mini TMS is roughly the size of a hardback book. It is only available as a rental, in three-month increments, at $250 per month. One-year rental averages $175 per month, and new prescriptions get a $300 discount for the first three months.
The Cefaly, manufactured by Cefaly Technology, is a battery powered unit that magnetically affixes to a reusable adhesive patch containing an electrode that is placed at the center of the forehead. Depending on the device's setting, it may prevent and/or abort a migraine. The device emits an electrical current to stimulate the trigeminal nerve and runs for about 20 minutes before stopping automatically. Prices start at $350 for the acute treatment or prevention setting, or $500 for both, with a 60-day money-back guarantee. The adhesive electrode patches cost extra, but they can be used multiple times.
Deena Kuruvilla, MD, assistant professor of neurology at Yale School of Medicine's Headache and Facial Pain Center, said that while the exact mechanisms of action of the nVNS device are unknown, one theory is that vagal nerve stimulation produces a rapid blocking effect on the pain spinal and supraspinal nociceptive pain pathways.
“I would consider this device for patients needing to acutely treat a migraine, especially those who have contraindications to abortive medications such as triptans or nonsteroidal anti-inflammatory drugs,” she told Neurology Today.
However, Dr. Kuruvilla said that cost is a major concern. “After the gammaCore device is turned on it will only operate for 31 consecutive days and then automatically deactivate. This means a new device must be ordered again. While there are ways to work with insurance companies to possibly cover the device, it is not always guaranteed.”
Alexander Mauskop, MD, FAAN, professor of clinical neurology at SUNY Downstate Medical Center, as well as founder and director of the New York Headache Center in New York City, told Neurology Today that the nVNS device builds upon a 2005 study that he published in Cephalagia.
In that study, a VNS device was implanted in four men and two women with disabling chronic cluster and migraines. VNS provided dramatic improvement in one of the men and one woman with chronic migraines.
“It is definitely nice to have these other options as an alternative to migraine drug treatments where some patients can have unacceptable side effects,” he said.
“The nVNS device is safe, but far from being as effective as triptans. Approval was based on good evidence, and 30 to 40 percent of patients get good results. We have had good success. I think that it is worth a free trial.”
Mark W. Green, MD, FAAN, professor of neurology at the Icahn School of Medicine at Mount Sinai and director of the Mount Sinai Center for Headache and Pain Medicine in New York City, said that while it is too early to tell how well the nVNS device will prove to be as an acute treatment for migraine, it has helped patients with cluster headaches.
“No one in our practice has a lot of experience with it yet,” Dr. Green said. “The device is somewhat successful in cluster headache but does not replace sumatriptan injections in my view. About half of my patients who use the Cefaly device find that it helps prevent migraines and improves their sleep, but then again, half of them do not like the device.”
And while Cefaly is less expensive, getting insurers to cover the cost is a big problem, he also told Neurology Today.
Noah Rosen, MD, adjunct professor of neurology at Albert Einstein College of Medicine and director of the Headache Center at North Shore-Cushing Neuroscience Institute in Manhasset, NY, said patients like both the nVNS and TMS devices.
“Patients want to have a choice, and while none of them are a cure, they expand the armamentarium and offer options for better control of migraines. The nVNS has the best data, and that is enough for me to start trying it.”
He also said that he has had “mixed results” in terms of insurer coverage, but even as an out-of-pocket expense the price might be comparable to what some patients pay for other drug treatments. “For a number of patients, the use of sumatriptan alone can run hundreds of dollars per month.”
Dr. Tassorelli received research grants from the European Commission and the Italian Ministry of Health, and received consultancy fees from Allergan and electroCore. Dr. Kuruvilla has received consulting fees from the GLG (Gerson Lehrman Group) about calcitonin gene-related peptide monoclonal antibody drugs that are pending FDA approval. She is also a paid speaker for Amgen Pharmaceuticals. Drs. Green, Mauskop, and Rosen reported no disclosures related to the study.