Federal Supply Schedule Adds External Vagus Nerve Stimulator for Headache Prevention and Treatment
A noninvasive vagus nerve stimulation (nVNS) device (gammaCore; electroCore, Basking Ridge, NJU) has been award a 5-year Federal Supply Schedule medical equipment and supply contract that makes the device available to over 21 million people whose health care is managed through the Department of Veteran’s, Department of Defense, Bureau of Prisons, Indian Health Services, and Public Health Services.
This nVNS device is approved for acute treatment of migraine and cluster headache and is portable and easy to use. It is also the first therapy of any kind approved for prevention of cluster headache. When used for acute treatment of migraine, patients place the device over their vagus nerve on the side of the neck and deliver 2 consecutive 2-minute doses of neurostimulation 10 seconds apart, which, if needed, can be repeated in 20 minutes and again after 2 hours to achieve relief from pain. For acute treatment of cluster headache, patients self-administer 3 2-minute stimulations 10 seconds apart that can be repeated after 20 minutes up to a maximum of 24 stimulations per day. When used for prevention of cluster headache, patients self-administer 3 consecutive 2-minute stimulations twice per day, first within 1 hour of waking and the second 7 to 10 hours later
“electroCore continues to focus on making gammaCore affordable, accessible and broadly available. With the FSS contract, we will deepen our commitment to the underserved patient population diagnosed with migraine or cluster headache, and are one step closer to ensuring patients who may benefit from gammaCore have access to this safe and effective therapy,” said Frank Amato, Chief Executive Officer, electroCore.
In clinical trials for prevention of cluster headache, the most recently approved indication for this nVNS device, intention-to-treat (ITT) patients (n = 45) had 3.9 fewer attacks per week compared with those who received the control standard of care treatment (P = .02). Of those treated, 40% experienced more than a 50% reduction in weekly cluster attacks compared to just 8.3% of patients who received the control standard of care (P < .001). Patients who used nVNA also had a 57% decrease in the use of abortive medications.