Tag: gammaCore

Treatment

How does the gammaCore work?

Kerrie Smyres

gammaCore is an external vagus nerve stimulator that is FDA-approved for treating cluster headache and migraine. To explain what makes the gammaCore work, I have to back up a bit to talk about the vagus nerve.

What is the vagus nerve?

image of the vagus nerve

The vagus nerve is the body’s longest cranial nerve and has many branches. It connects to numerous organs, including the heart, lungs, and stomach. (The vagus nerve is shown in yellow in the image.) Here’s how electroCore, the company that makes gammaCore, describes the vagus nerve:

It is the longest cranial nerve in the body, primarily serving as a sensory nerve, bringing information from the visceral organs to the brain. The vagus nerve has a number of branching nerves that go to the heart, lungs, voice box, stomach, ears, and other organs. As a sensory nerve that assesses the condition of these organs, it is the communication between the brain and the body. It contains motor and sensory fibers and, because it passes through the neck and thorax to the abdomen, has the widest distribution in the body.

While we don’t hear as much about the vagus nerve as we do the occipital or trigeminal nerves, researchers believe it plays an important role in both migraine and cluster headache. You’ve likely heard of the vagus nerve in connection with it’s most “famous” responsibilities: it plays a central role in the fight-or-flight response and it connects the brain to the stomach, sending signals between the two. (Since eating anything is a migraine trigger for me, this connection is what prompted me to travel to Canada to try the gammaCore.)

How does the gammaCore work?

Like with so many therapies, how the gammaCore works isn’t entirely known. electroCore’s website currently says, “Stimulating the vagus nerve affects many important autonomic functions in the brain and in the body, including neurotransmitter levels, inflammation levels, and metabolism.” In videos published in 2012 and 2014, electroCore explains the role of neurotransmitters and how the gammaCore influences them. Here’s my summary (and you can watch the videos yourself below).

The gammaCore is thought to balance neurotransmitters, which help regulate a person’s nervous system. Neurotransmitters can be classified as excitatory or inhibitory. Excitatory neurotransmitters rev up the nervous system; inhibitory neurotransmitters calm the nervous system. The brain tries to maintain an equilibrium by constantly balancing excitatory and inhibitory neurotransmitters. Scientists believe that people with headache disorders like migraine and cluster headache may have too many excitatory neurotransmitters and not enough inhibitory neurotransmitters. One particular neurotransmitter, glutamate, is particularly suspect. The gammaCore is thought to balance neurotransmitters by stimulating the “nervous system’s superhighway,” as electroCore calls the vagus nerve.

Video Explanations of How the gammaCore Works

These videos from electroCore, the company that makes the gammaCore, give a better explanation than I can. The information in the two videos is basically the same—the first is the layperson’s explanation and the second is more technical. Both videos are worth watching, though I recommend starting with the intro video. (You may be annoyed by the narrators’ liberal use of the word “headache”—it can seem like they minimize the severity of migraine and cluster headache. I give them leeway because they’re trying to encompass both migraine and

Treatment

What does the gammaCore cost? (And is the gammaCore covered by insurance?)

Kerrie Smyres

Updated 2/8/18: I have updated information after speaking with a patient education specialist today. What the representative I spoke with Tuesday told me was mostly accurate, but not entirely. I’ve added updates throughout the post. I’m embarrassed by all the changes and apologize for passing on incorrect information.

gammaCore Cost

gammacore cost and insurance coverage

The list gammaCore cost is $600 per device and needs to be “refilled” every 31 days. You have unlimited use of the device for one month, then it will stop working. A “refill” means buying a new device. Yes, you read that correctly—the gammaCore cost is $600 a month ($7,200 a year) without insurance. This pricing model is both ridiculously expensive and wasteful. It’s also 2.5 times what mine cost before it was available in the US market (more on that in a bit).

Update 2/8: The out-of-pocket cost for the foreseeable future is $498 a month ($5,976 a year). The device costs $575 a month and fees for the speciality pharmacy that sends the device add $23 per month, for a total of $598. The pharmacy automatically applies a $100 discount for people with migraine or cluster headache, which electroCore is calling “copay assistance.” The discount applies every month and does not currently have an expiration (though that may change).

gammaCore Insurance Coverage

gammaCore representatives say they are working with all US insurance companies to get the device covered. Currently, coverage is on an individual patient basis. To see if your insurance company will cover it, you need to contact them directly and ask for their protocol for covering medical devices. You will almost certainly need to submit documentation from your doctor about the severity and frequency of your migraine attacks or cluster headache attacks and information on other treatments you have tried. gammaCore customer service can help you determine which information will help make your case with the insurance company. If you decide to purchase the device before getting approval from your insurance company, you can submit for reimbursement (though there’s no guarantee the insurance company will reimburse you). gammaCore customer service ((888) 903-CORE) can help you with that process.

I will be trying to get coverage through my insurance company and will keep you posted on the process.

Update 2/8: gammaCore is supplied through a speciality pharmacy, which will contact your insurance company for you. Your doctor prescribes the device using the gammaCore enrollment form, which they submit to the specialty pharmacy. Before filling the prescription, the specialty pharmacy will contact your insurance company. If your insurance company requests additional information to prove the device is medically necessary, the pharmacy will get the information from your doctor and submit it to insurance. The pharmacy will let you know whether your insurance will cover the device and how much they will pay for. The whole process usually takes about a week.

When I asked if contacting my insurance company directly would help, I was told it wasn’t necessary, but it couldn’t hurt and will raise awareness of the gammaCore as a treatment option.

Two Free Months of gammaCore Use

The gammaCore Patient Registry (GPR) will give a patient with migraine or cluster headache two free months of use if they qualify for the program. The GPR is basically a follow-up study to see how the device works “in the wild” for a large number of patients. If there’s a GPR site near you and you qualify, you may try the device out at no charge for two months in exchange for frequent reporting on your migraine symptoms and use of the device. If you decided to continue using it, you may then qualify for a year of use at a discounted rate. To find out if there’s a GPR site near you, call (888) 903-CORE.

I am going to look into the GPR for myself, but don’t think I will qualify since I’ve been using the device for almost 20 months. I’ll let you know what I learn and if I am able to participate.

Update 2/8: The GPR is currently only for people with episodic cluster headache. There may be a GPR for migraine in the future, but one is not currently in the works.

Patient Assistance Program

Patients who meet financial qualifications may receive a discount on the gammaCore. This is similar to prescription assistance programs, which are income-based. Call (888) 903-CORE for details.

Everyone who orders a gammaCore for migraine or cluster headache gets a $100 “copay assistance” on every order. There is no financial need qualification. This is a $100 discount off the price of the device, no matter if you have insurance or not and no matter how much your insurance covers. The copay assistance is not time-limited, though electroCore may discontinue the program at any time. A patient assistance program may be developed in the future.

My gammaCore Cost Thus Far

I went to Canada to get the gammaCore because it was approved there years before it was available in the US. The pricing model for the device changed last summer, when the gammaCore received FDA approval for cluster headache. The device that used to cost me less than $3,000 a year will now cost $7,200 a year if my insurance doesn’t cover it. Depending on the exchange rate, I used to pay about $550 for a device with 300 uses that could be used in any time frame. Because I get a migraine attack every time I eat, I went down to two meals a day so each device lasted 2.5 months. It used to cost me about $1.85 per use. At the new pricing, it will cost $5 per use. The 300-use device is no longer available; it now needs to be replaced every 31 days in Canada and, I believe, every country it is available. I assume electroCore, the company that makes gammaCore, changed the device settings and pricing model for the US insurance market.

How I Paid for the gammaCore

I received my first gammaCore free (it was the program electroCore offered at the time), then paid for subsequent devices myself. Yes, it was expensive; I justified the cost because it allowed me to increase my productivity at TheraSpecs. The idea with any treatment I try is that if it works, it will pay for itself by allowing me to work more. I know this is a luxury allowed by my unusual work setup, which doesn’t apply to most people.