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New migraine drugs promise relief — but at a steep price

New migraine drugs promise relief — but at a steep price


They're estimated to cost between $8,000 to $20,000 a year

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James Bareham

The migraines started when I was 12. Back then, I used to get persistent, mind-splitting headaches two or three times a month. The throbbing pain in my head, usually behind my left eye, often came with nausea, sometimes with vomiting, and always with extreme sensitivity to sound and light. I couldn’t do anything but swallow an Advil and lie down in my room in the dark. I missed a lot of childhood dance classes that way.

The migraines went away when I was 16 or so — until eight months ago, when they returned stronger and more frequent, almost every other day. Painkillers like ibuprofen, acetaminophen, and aspirin often didn’t work; to the point that if I went to bed with a migraine I was 100 percent sure I would wake up with one.

If I went to bed with a migraine I was 100 percent sure I would wake up with one

Anyone who suffers from migraines — about 36 million Americans do — can tell you how discouraging they are. Many people don’t understand how debilitating they can be — after all, everyone gets headaches, right? And because existing treatments often aren’t successful, migraines can end up taking a toll on your social and professional life. That’s why I was excited when I first heard about a new class of drugs that are being developed specifically for preventing migraines.

The new migraine-specific drug is being developed by four pharmaceutical companies in the US and they may receive regulatory approval as early as 2019. They neutralize the activity of a chemical used by nerve cells to transmit pain signals in the brain when a migraine occurs. For now, they seem to be working better than other preventive treatments — with no major side effects. However, the drugs are expected to cost thousands of dollars a year, raising concerns about who can really afford them.

"So far, they’re looking good in clinical trials, the results are fairly good, the safety studies thus far look good, and hopefully they’ll come to market," says Deborah Friedman, a neurology professor at University of Texas Southwestern Medical Center. "But I think we’re all concerned about the cost of these drugs."

What exactly are migraines?

Migraines are more than just intense headaches. It’s like "sitting in front of the television and all of a sudden, the volume keeps going up and going up and going up, and you’re not even holding the remote," says David Dodick, director or the migraine program at the Mayo Clinic in Arizona, president of the International Headache Society, and chairman of the American Migraine Foundation. Light seems brighter, sounds are louder, and smells are stronger. "The volume on everything is up," he says.

As if that weren’t bad enough, migraines can last for days. About 12 percent of the US population gets migraines, costing about $20 billion a year in medical expenses and lost productivity, according to the American Migraine Foundation. The World Health Organization considers migraines to be the sixth most disabling disease in the world. Despite how painful and widespread migraines are, treatments are limited. My own visit to a specialist brought some physical relief but also a sense of resignation.

"I think we’re all concerned about the cost of these drugs."

The first thing you learn when you go see a migraine specialist is that there’s no cure. There’s also no treatment that’s specifically designed to prevent the attacks. All the preventive medications are designed to treat other conditions, like hypertension and depression. The drugs aren’t very effective — they work in about half of patients — and they often have terrible side effects, like weight gain, fatigue, and difficulty in thinking and speaking clearly. When I saw the specialist, I was first prescribed tricyclic antidepressants. They made me groggy; my brain felt like it had been dipped in thick molasses. I took only one pill before calling my doctor and telling him we had to find another therapy.

Now, I’m taking beta blockers, a class of drugs used for high blood pressure and heart problems; in the 1960s, these drugs were found to relieve migraines, too. (To this day, doctors don’t really understand how.) I’m also getting daily supplements of magnesium and vitamin B12, as well as monthly injections of the same drugs. And, like many other migraine patients, I was advised to make some lifestyle changes. I quit drinking coffee completely (that was hard) and alcohol almost completely (less hard). I never skip a meal. I stretch in the morning to relax my muscles and swim at least once a week. I also try to manage stress — a major migraine trigger — with breathing exercises.

A collection of all the drugs I take to manage my migraines

Because I have health insurance, the costs have been manageable. Beta blockers, and all other preventive medications for migraines except Botox, have been around for a long time, so cheap generics are available. The beta blocker I’m taking, atenolol, costs around $14 a month. The magnesium and B12 injections are expensive — not because the drugs themselves are expensive, but because of the fee the doctor charges to inject the drug. One gram of magnesium, for example, is $50, but I was charged an extra $300 for the intravenous injection. My specialist also charges between $250 and $600 per visit. The migraines haven’t disappeared, but my attacks are less severe and somewhat less frequent. And if I get a particularly bad headache, I can take a migraine-specific painkiller called triptan, which is quite fast and effective in muting attacks. Other than a little fatigue, the preventive drugs don’t have major side effects for me. The magnesium injections are weird, though. They make your mouth feel super hot, as if it’s catching fire.

‘There's a lot of money to be made’

Because the existing migraine treatments are hit-and-miss, it’s no wonder that the new drugs excite people so much. "New nerve drugs may finally prevent migraine headaches," Scientific American wrote in December 2015. "Will antibodies finally put an end to migraines?" asked Science in January. Dodick, who has consulted for several of the companies developing the drugs, says they could be a revolution for migraine patients. "You’ve got millions of lives that could be possibly affected by this. There’s a lot at stake. And I see patients every day whose lives have been totally wrecked by this disease," Dodick says. "The excitement is beyond words."

The new drugs are not a pill, but injections of laboratory-made molecules called monoclonal antibodies. They block the function of a small protein that widens blood vessels and helps transmit pain signals throughout the body. This protein, called CGRP, has been known to play a role in migraines for more than 20 years.

"You’ve got millions of lives that could be possibly affected by this. There’s a lot at stake."

The four pharmaceutical companies developing the drugs — Alder BioPharmaceuticals, Amgen, Eli Lilly, and Teva — are all testing slightly different antibodies, administered at different times. (Allergan is also developing a CGRP-neutralizing drug; it’s a pill, and it’s not as far along in tests as the injections.) Some are testing monthly injections, others are testing injections every three months. Most companies have finished their phase 2 clinical trials and are conducting phase 3 trials, the last rounds of testing typically required for FDA approval. So far the results are promising. The patients in one of Amgen’s trials, for instance, had to have up to 14 migraines a month to be admitted to the study. After a year of injections, they had half as many days with a migraine each month. That means that some people who had 14 migraines a month got an entire week of their life back. And for a lucky few in these trials, the migraines disappeared completely.

But because the drugs are monoclonal antibodies, which are made from living cells and are expensive to produce, they’re expected to have hefty prices. In fact, some of the priciest drugs on the market today are monoclonal antibodies. For instance, Genentech’s Avastin, which is used to treat cancer, can cost $50,000 a year. Alexion’s Soliris, which treats a rare immune disorder, has been dubbed by Forbes as "the world’s single most expensive drug" and can cost as much as $400,000 a year.

Monoclonal antibodies are made from living cells and are expensive to produce

How expensive will the migraine drugs be? Estimates vary. According to Eric Schmidt, an analyst at Cowen & Co. who covers biotech companies, they’re likely to be priced around $8,000 to $10,000 a year. Other experts estimated prices as high as $20,000 a year. Only Randy Schatzman, the CEO of Alder BioPharmaceuticals, was willing to discuss the price. Alder is closely following another class of antibodies used to lower cholesterol. Those antibodies cost $14,000 when they came out. "I suspect we might be in that ballpark," Schatzman says. Lilly, Amgen, and Teva declined to comment. One thing seems clear, as Dodick put it: "There’s a lot of money to be made."

If the price is high, health insurance companies will be more likely to restrict access to the antibodies, just like they do for Allergan’s Botox, analysts and migraine specialists say. Botox — the only botulinum toxin that’s FDA approved to treat patients that have 15 or more migraines a month — is the most expensive migraine treatment. A vial of Botox costs about $1,100. Patients usually need injections of four vials a year and are charged injection fees; that means Botox treatment for migraines can cost $6,000 to $10,000 a year. For Medicare patients with no secondary insurance, the out-of-pocket costs are more likely to be around $1,200, according to Deanne Grossman, who works in the billing department at the Headache Center at Jefferson University. But the already steep price can climb even higher if the patient needs a higher dosage. The result: less than 1 percent of chronic migraine sufferers in the US — just 100,000 people — are treated with Botox, according to Alexander Mauskop of the New York Headache Center.

Clockwise from left to right: Magnesium, Valerian root, vitamin B12, ibuprofen, and tricyclic antidepressants

Because Botox is so costly, almost all health insurance companies require patients to try and fail at least two or more other treatments before they’re allowed to receive Botox injections. (I haven’t tried Botox, because I’m still trying less expensive treatments.) Most of the migraine specialists and analysts I talked to think that the new migraine-fighting monoclonal antibodies will be similarly restricted. Stephen Silberstein, a professor of neurology at Thomas Jefferson University and the director of the Jefferson Headache Center, who’s studied migraines for over 20 years, said he wouldn’t be surprised if insurance companies required patients to even try and fail Botox before getting access to the more expensive antibodies. Requiring patients to fail several medications is expensive for patients and adds another layer of restrictions, especially for low-income people who are even more likely to get migraines compared to their high-income counterparts.

"I suspect that we’re going to have to jump through some hoops in order to get [the antibodies]," says Friedman, the neurology professor at University of Texas Southwestern Medical Center. "I wish that was not true, but I suspect it is going to be true."

The genetics of migraines

Like many other migraine patients, I was shocked when I was prescribed antidepressants to treat my headache problem. I was relieved but still a bit confused when I was told to take high blood pressure medication, even though my blood pressure is totally fine. The reason why no migraine-specific medications exist is that migraines, which tend to occur in women more than men, often aren’t taken very seriously. Migraines also receive little research funding. "It hasn’t been thought of as a serious problem, so why spend money on it?" says Peter Goadsby, a migraine research pioneer who helped identify the role of CGRP in migraines. The National Institutes of Health, the major source of public research funding in the US, granted $19 million for migraine research in 2013, about 0.012 percent of its research budget, according to the American Migraine Foundation.

Migraines appear to be hereditary

All this has caused a huge delay in understanding how migraines actually work. It doesn’t help that migraines are a complex neurological disorder; more than 40 genes are associated with migraines, and they appear to be hereditary. (One of the first things my specialist asked me on my first visit was if anyone in my family suffered from migraines. My grandmother did. Twenty years after she died, I found an old aspirin in an otherwise empty pink purse of hers. She always carried painkillers with her, in case of an attack.) Because there isn't just one gene involved, it's harder to tackle the disease. And that’s why we had to wait until today to see some successful migraine-specific drugs that researchers believe might revolutionize the field.

There are, of course, reasons to be cautious. About half of drugs in development fail in late-stage trials, according to Nature. Dangerous side effects could be discovered when the antibodies are tested on thousands more patients during phase 3 trials. We also have to think about the long-term health effects of neutralizing CGRP, says Elizabeth Loder, chief of the headache division at Brigham and Women’s Hospital in Boston and former president of the American Headache Society. CGRP is distributed throughout the body and plays a role in many physiological processes, from wound-healing to regulating blood flow to the heart and brain, she says. What happens if you block CGRP over long periods of time? "I don’t think we know," says Loder.

"Will [the new treatment] be a viable option? I think that remains to be seen," she says. "These are going to be expensive drugs. We don’t know what their long-term safety record is."

As a migraine patient who wakes up every day wondering whether I’ll get a headache, I can’t help but feel excited about the monoclonal antibodies. For all the hype, though, I wonder if the new drugs are likely to be a disappointment, too — at least for those patients who can’t afford them or can’t access them because of the hurdles put forth by their health insurance companies.