Implementing Neuromodulation Devices Into Migraine Treatment Plan With Dr Stewart Tepper

In Part 2 of this podcast, Neurology Learning Network Section Editor Dr Stewart Tepper, MD, Professor of Neurology, Geisel School of Medicine, Director, Dartmouth Headache Center, discusses his approach to integrating neuromodulation devices into patients' migraine treatment plans, how they work in conjunction with other therapies, and advice for clinicians seeking to incorporate them into their practices. 

Listen to Part 1, where Dr Tepper provides an overview of neruomodulation devices, here!

Heather Flint: Hello Neurology Learning Network. I'm your senior digital managing editor, Heather Flint. And I am joined today by Dr. Stewart Tepper. And we're going to discuss migraine treatments and neuromodulation devices. Dr. Tepper, if you can introduce yourself, please.

Dr Stewart Tepper: Hello, I'm Stewart Tepper. I'm a professor of neurology at Dartmouth and I'm director of the Dartmouth Headache Center in New Hampshire.

Heather Flint: So when we're talking about the devices it seems that the majority of them are both for preventive and abortive purposes. What do you do and what steps do you take when you're looking at which device would be most beneficial for the patient?

Dr Stewart Tepper: Well, unfortunately the very first issue is access. And, commercial payers are refusing to pay for these devices with very few exceptions.  These are not experimental devices. These are FDA-cleared devices with nonsignificant risk that are extremely useful for large numbers of patients.  The VA does pay for all of them. So, first question I ask is, are you a veteran? And even though it's a little bureaucratic to get them through the VA, at least people can get them through the VA. And then I need to actually figure out what a particular patient can afford. And they are gradated by how expensive they are really. And also whether a patient needs both a preventive and acute treatment, or can get away with just an acute treatment.  

So, let's talk about the external trigeminal neuro stimulator first, that's the one that goes on the forehead. It has some variable cost, but the advantage of it is that a patient can buy it upfront and own it. And the cost for the upfront purchase of the device ranges from $300 to $400 once, depends on whether they have deals in place or not. The electrodes that go on the forehead that the device clicks onto wear out, they lose their stickiness and patients buy 3 electrodes for $25. And if they really baby them, they can make an electrode last a month. So there is an ongoing cost, $25 every 3 months. And they do offer a monthly payment for the device to buy it. And they offer a 3-month guarantee for returning it. And that's the one that's available without a prescription. So when patients need both prevention and acute neuromodulation, that's the one that most of them can afford.

The next is the single pulse transcranial magnetic stimulator, the magnet that one costs 3…I'm just going in the order in which they were released, that costs $350 per month to rent. And the patient has to pay the first 3 months of $350, so over a $1000 upfront at the beginning. And so most patients cannot afford that. The next one, the noninvasive vagal nerve stimulator is over $600 a month to rent and work with. And again, most patients cannot afford that. There are some centers that have some deals on particular neuromodulation devices, but you can see why the external trigeminal neurostimulator becomes the one that most patients use when they need both acute and preventive treatment. The remote electrical neuromodulation device, the one that goes on the arm for just acute treatment, that one is affordable. Each device has enough juice in it to treat 12 migraines. And so each device is good for 12 attacks or 12 treatments. Everybody who wants to try that can try it out for $10.

So, $10 to treat 12 times. And then the device is $50 per device thereafter. Somebody with episodic migraine who has 3 or 4 attacks per month, $50 for 3 months becomes a very reasonable price. And so when somebody just needs acute, that's the one we use. And then the Relivion device is gradually being rolled out. There is a trial period where patients can try it for free, but it is $75 a month as I understand it thereafter, after the 2- or 3-month trial period. I'm not sure. So, you can see the costs here are significant. They're also less than that of monoclonal antibodies or  botulinum toxin A. And so the discussion about cost and access becomes foremost in the discussion with patients about which one to use.

Heather Flint: Do you find that using these as standalone treatments is most effective or potentially using them in tandem with medication therapy is most effective?

Dr. Stewart Tepper: Well, actually we do both. And I think what would be useful for neurologists listening is to know the kinds of patients for whom noninvasive neuromodulation is really worth thinking about. And it's at a very large number of patients. So let me just take you through it. One is a young patient tech savvy, in her 20s, doesn't want drugs, has episodic migraine. Perfect. Right. They love the idea of treating without drugs. The second would be somebody at the other end of migraine. That is somebody who has chronic migraine who's tried a million drugs and they fail. Then it seems like we don't have the right target for that patient. And neuromodulation affects the whole brain and the pain regulatory pathways, the targets we know about, the targets we don't know about. And it is quite common to have people who have had zillion drugs fail to respond to noninvasive neuromodulation and well worth considering in people who come in with a long list of drugs that have failed for them.

Patients who want to get pregnant and who are concerned about using medications as they approach pregnancy. And the demographics of migraine is young menstruating women or patients that you're concerned about because they don't have good contraception, another group. And then get directly answering your question, these can be used adjunctively. They can be used on top of medication. They can combine with medication, both acutely and preventively. We do that routinely as add-ons for patients. The adjunctive use has not been studied. In fact, what's been studied is how well do they work in the absence of medication? How well do they work in a way in which the patient does not have to take rescue medication? For example, there was a large study published of over a thousand patients who use the remote electrical neuromodulation device to terminate their attacks.

And the criterion for a successful treatment was that they didn't have to follow up with a triptan or another acute medicine. So, it can be used both ways, but I certainly tell people if you are to taking a medicine and that medicine is not completely consistent, and you don't want to try another medicine, we could certainly add noninvasive neuromodulation device for you to use at that time. So, that's a lot of patients. You got patients at both ends of the spectrum and patients are extremely interested in using these devices because of the absence of side effects and the lack of drug- drug interactions.

Heather Flint: So, just to sort of tie things up with prescribing these types of treatments or discussing with patients, are there any additional tips or insights that you want to share with other clinicians when starting to think about bringing this into their treatment plans?

Dr Stewart Tepper: Well, I want to encourage it. That's the first point. I think that noninvasive neuromodulation ought to be part and parcel of every provider's treatment armamentarium in treating primary headache disorders, because they can be very useful. Another area by the way, where we use them, that I forgot to mention is when you have concern about patient adherence, where you have patients who have frequently canceled appointments and no showed and didn't follow up for what they were supposed to be doing or altered their treatments at home without consulting back with you, which happens with unfortunate frequency. And I always have concerns about starting these patients on medications, especially medicines that requires some monitoring. And then the patient doesn't show up again, and you don't know what's happened, or, and you can't follow-up in some reasonable way. And if there's lab data that you need to obtain or an EKG, you can't get that. So, in patients where you have those concerns, noninvasive neuromodulation is clearly the way to go. And in those cases you would do it as monotherapy.

What would be useful for you is, as a provider is to just gather how you prescribe these. And I'm pretty blunt with my patients. I say, are you independently wealthy? And if they say yes, then you can prescribe any of them and you can make your determination based on the fact that cost is not an issue. On the other hand, if you know that the patient is on public assistance of some sort, then you have to be very careful and gentle in how you present and think about what the implications would be for this patient. But having a guide to how you prescribe each one is worthwhile. It'll take a little bit of time. You got to go on to 5 different websites to find out. Some of them require a specialty pharmacy. The remote electrical neuromodulation requires a specialty pharmacy to distribute it.

And the noninvasive vagal nerve stimulator and the single pulse transcranial magnetic stimulator are shipped from the companies. The one that's over the counter, obviously the external trigeminal neurostimulator that also is ordered from the company. So as a provider, it's worth spending a little bit of time getting all of that information in front of you. You can have your nurse present this to the patient. You can have your nurse do training with the patient, and that helps, but I would really strongly urge you to integrate these treatments. Because it can really, really help extend the opportunities for patients to get control over their headaches. And in some ways it's shifting the locus of control from you to the patient, which can be an optimal therapeutic intervention that you can help with.

Heather Flint: Excellent. I appreciate that. And I appreciate you giving us such a comprehensive overview of these devices and also being open about the challenges, obviously cost being the most significant of those. But it's great to have providers get the full scope of what we're looking for and be able to share that with our audience is much appreciated. So I do want to thank you again for joining us today. We really appreciate your insights and expertise.

Dr. Stewart Tepper: All right. Well, thank you very much.

Stewart Tepper, MD, is a professor of Neurology at the Geisel School of Medicine at Dartmouth, Director of the Dartmouth Headache Center, and a board member at large of the American Headache Society.