Headache Medicine: What's on the Horizon for 2021?

In this video, Stephanie Nahas, MD, MSEd, discusses anticipated developments in headache medicine this year, including new indications for pharmacologic therapies, the use of devices, advocacy, and more. A full transcript is provided below.

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Stephanie J. Nahas, MD, MSEd, is an Associate Professor of Neurology, and Director of the Headache Medicine Fellowship Program at Thomas Jefferson University in Philadelphia, Pennsylvania.

Transcript:

Dr Stephanie Nahas: Hi, I'm Stephanie Nahas. I'm an associate professor of neurology and headache medicine specialist at Thomas Jefferson University Jefferson Headache Center in Philadelphia, Pennsylvania. 

I'm here today for this month's podcast on what's new to be expected in headache medicine in 2021.

We're in a new year, but we don't have a new pandemic. We're still dealing with the old one. COVID‑19 isn't going away anytime soon, and headache is recognized as one of the cardinal symptoms of the infection.

We're still seeing a lot of patients who have had headache develop anew with COVID‑19 or be exacerbated by COVID‑19. We have yet to identify any specific treatments to alleviate the headache that is caused by or aggravated by the virus. Hopefully, more research will shed light on treatments that may be uniquely useful in this circumstance. 

Thankfully, we finally have some vaccines coming on line to prevent infections, or prevent severe infections, and hopefully to prevent headache. 

The vaccine, itself, can be associated with headache. We've seen some patients who have had headache triggered by the vaccine anew, as well as patients who already have migraine and experience worsening of their existing migraine disease due to the vaccine. 

Thankfully, this is usually transient in nature. Furthermore, I've had plenty of patients who've gotten the vaccine and had no trouble whatsoever. Not much more than a sore arm for a few hours. 

Much study remains to be done. There's a lot more to be learned about this virus, its treatment, its prevention, and where headache may fit in, but I'm hopeful that by the end of this year our knowledge will be much more magnified. 

Being in the pandemic, we're still utilizing telemedicine quite a bit, but the rules remain a bit fuzzy as to how we can, for example, care for patients in other states that we don't hold licenses in, or maybe even abroad. I'm still waiting on confirmation on whether the contingency measures put into place to allow us to practice freely across the nation will remain in place.

I was recently notified that Florida is requiring a special registration in order to be able to provide care for patients who are in Florida if the clinician is out of state. I imagine that other states will start to come up with their own rules with respect to this, as well. 

In addition, who knows what insurance companies will do, what CMS will do with respect to reimbursement for telemedicine. 

Just about everybody agrees this has been one of those silver linings and something that has been tremendously helpful for the advancement of patient care, specifically for patients who have headache and migraine, as we've touched on in previous podcasts. Stay tuned for more information on how telemedicine is going to advance this year and become more of a mainstay of clinical care, especially with respect to headache.

On the scientific front, there's a lot of data that we're really looking forward to with respect to headache and migraine medicine. 

The monoclonal antibodies have been on the scene for a couple of years now, but more and more data are continuing to accumulate and to be published and presented with subgroup analyses. Not just, for example, populations who are older or populations who've experienced prior treatment failures.

We may start to see some evidence of selecting who is most likely to respond to these treatments. 

In addition, we're accumulating and starting to see more and more pharmacoeconomic data to help prove that, although these treatments are relatively expensive, in the long run they wind up saving money, saving resources, and improving the pharmacoeconomic landscape overall. I'm really hopeful for more information on that. 

Besides more information on the monoclonal antibodies, which target the calcitonin gene‑related peptide system, CGRP for short, the gepants have been out for a year now. These are oral medications which antagonize the CGRP receptor. 

More data are expected for ubrogepant and rimegepant, which already on the market, as well as atogepant, which is yet to come to market, and probably won't until 2022. Perhaps the most exciting thing with respect to gepants is that we are hopeful that this year rimegepant will get an indication for the preventive treatment of migraine or migraine reduction with every‑other‑day dosing.   

Some other exciting science is revolving around work being done at Mass General Hospital and Harvard with respect to predicting migraine attacks. This may add another layer to migraine management, not just focusing on migraine prevention or migraine reduction over time, and migraine acute treatment or attack therapy, how to deal with the attack once it starts, but predicting one before it even occurs. 

It's been of great interest for a number of years to identify what predictors there may be. Triggers, for example, or other data points, other aspects of what's going on in nature, what's going on in the environment, what's going on with the individual that might predict that they're headed for trouble and headed for a migraine attack.

We are now at the point where we're talking about not just acute and preventive, but also preemptive. We have already some strategies that are preemptive in nature, for example menstrual migraines, probably the best example. 

When a woman has a regular menstrual cycle, knows when it's coming, and knows that she's going to have bad migraine attacks during that period of time, she can preemptively start taking medication or taking other measures to reduce the burden and the impact of the attacks that are expected to occur that week. 

What if we don't have something so reliable as a biological cycle to predict when an attack may occur? 

What if there are other ways that we may be able to predict that somebody is headed for trouble? Certain things that they can track in a diary or other wearable devices that may monitor other biologic parameters that help a person know when they're headed for trouble. 

I'm really excited to see what more comes out of this research and other research being done in the prediction of migraine attacks. 

Finally, there are a number of devices which have been FDA cleared for the treatment of migraine already. We're expecting more data and perhaps more clearances in the future. 

For example, one of the most interesting devices, and there's nothing on the market like it yet, is a caloric stimulation device. It's like a fancy set of headphones. They go within the ear canal to deliver caloric stimulation. In other words, temperature modulation as a neuromodulatory attempt at treating and preventing migraine attacks. 

There are also other potential applications for this type of technology. Stay tuned. 

The FDA has already reviewed this device for its use in migraine and deemed it nonsignificant risk, but has not yet given it clearance. Still considered investigational.

There are other devices which stimulate the vagus nerve or the fastigial nucleus of the cerebellum, the cortex, all with electricity, that we're looking forward to hearing more about and eventually coming to market to help our patients who need more than just what medications and current devices can offer.

Not only does 2021 bring us a brand new year, but we have a brand new government and a brand new administration. We are once again, through the Alliance for Headache Disorders Advocacy, going to Capitol Hill this late winter, early spring. 

We've done this every year since 2007 to advocate for legislative changes for the betterment of patients, clinicians, and scientists who care about headache and who care about migraine.

This year's event is going to be all virtual for the very first time, but this also allows for much greater flexibility for us as constituents to speak to our lawmakers without having to travel and without as many constraints on our schedules. 

We have more advocates who've applied for this process than ever, close to 300. We have almost every state covered and more legislative districts than ever covered.

Hopefully, we'll be able to continue to build on the successes that we've already achieved. Most notably, getting greater funding for headache research and greater respect for headache medicine and headache science in general. 

You can learn more on our website, the Alliance for Headache Disorders Advocacy. Check us out. 

The key takeaways that I would leave for you guys is that we're entering a brand new era in so many different respects. Headache science and headache medicine is no different.

I'm glad that you're in this game. I hope that you're motivated to stay in this game, and to even elevate your own game and come up to the bigger leagues of managing headache, battling migraine, and swimming in all that is desirable, engaging, intellectually stimulating, and challenging for those of us who care so much about headache medicine.

Thanks for joining me.