The Most Promising Migraine Drug in Years Is Being Held Hostage by Our Healthcare Dystopia
The last seven weeks have been some of the least painful I’ve lived since I was 16 years old.
Normally, I have an incapacitating migraine roughly once a week and spend many other days each month enduring pounding, painful, and tiresome headaches that threaten to turn into full-blown migraines. Sometimes the migraines last days, causing me to miss work because I can’t get out of bed.
But on July 31, I took my first dose of Aimovig, a first-of-its-kind migraine drug approved by the FDA in May. Since then, I’ve only had two full-blown migraines, with just three or four days where I’ve had to take any kind of prescription migraine medication. I have missed fewer days of work and fewer social occasions. Headaches that previously might have turned into full-blown migraines and lasted half the week are gone after a few hours or the next day.
My life isn’t exactly normal—I still get headaches and migraines, still have to be careful to stay hydrated and not have too much caffeine. I haven’t tried having a glass of wine yet, which has historically been an express ticket to migraine hell. This could all be temporary or a placebo effect. But maybe it isn’t—maybe the drug really is working. Many other Aimovig users are reporting the same positive effects.
As with every aspect of healthcare in America, many migraine sufferers who are poor or uninsured do not have such happy stories to tell. Despite the manufacturers’ programs to improve access to the drug, it’s still not easy to get. Insurers are already putting coverage restrictions in place, as are some Medicaid plans, and not every state’s Medicaid program will cover it yet. And if you’re too poor to see a doctor, how could you be prescribed—or maybe even aware the drug exists—in the first place?
Aimovig, which was approved by the FDA in May, is the first of a new class of migraine drugs called CGRP inhibitors; the second, Ajovy, was just approved by the FDA last week, and a third may be approved by the end of the month.
Evidence from clinical trials shows Aimovig only reduces migraine days by one or two per month better than a placebo, although for some patients, it’s significantly more. About half of patients in trials had their migraine days cut in half. But what makes Aimovig so different to previous classes of migraine drugs is the relative lack of side effects.
The main side effects for Aimovig are pain at the injection site and constipation, both of which are easily remedied. Traditional migraine drugs have much more significant side effects, ranging from hair loss to dizziness to nausea to nightmares to depression.
A migraine drug that offers relief without major side effects has been something of a holy grail: Even something that doesn’t cure them entirely can be life-changing.
These side effects are a major barrier to treating migraines. A study published in the headache medical journal Cephalalgia found that 86 percent of patients on migraine medications discontinue them within a year, with the two most common reasons being the side effects and efficacy. About half stop taking their drugs within 60 days. So a migraine drug that offers relief without major side effects has been a kind of holy grail for sufferers: Even something that doesn’t cure them entirely can be life-changing, especially if they don’t then have to balance those gains with losing their hair or mental sluggishness. Of course, the question is always: How much would such a drug cost?
When Aimovig first entered the migraine drug market in May, the list price was set at $575 per month, but Amgen and Novartis, the companies that make it, are providing the drug for free for two months. When you get prescribed Aimovig, you can’t just go down to your local CVS and pick it up. Your doctor sends a form directly to the companies and they call you to schedule a delivery of the drug, which arrives in a refrigerated container like it’s plutonium. This process sometimes introduces delays—my first shipment was delayed by about a month because they had my phone number wrong. (The migraine subreddit is full of stories like this.)
After the two months are up, if the patient has commercial insurance, they can keep getting it for free for up to 12 months while insurers figure out whether they’ll cover it. I’m at the end of the two months free period now and waiting to see if my insurance will approve the prior authorization my doctor has requested—but because I have commercial insurance, I know the drug companies will cover me for the year. The companies also have a program, Aimovig Ally, to help uninsured and low-income patients access the drug.
But even with these ostensibly generous programs in place, it’s been an uphill battle for low-income migraine sufferers to get the drug. Insurance restrictions and confusion about what’s covered are only part of the story, because many people are too poor to even see a doctor, let alone a neurologist.
Our healthcare system throws up barrier after barrier at migraine patients, most of all the low-income ones. Migraines are already widely misunderstood, discouraging people, especially women, from seeking care. If you have insurance, you have to jump through hoops to get the drugs you need, and if your insurance company doesn’t cover them, you’ll have to pay the sticker price. You might have to pay high co-pays to see a specialist and meet high deductibles to pay for tests. If you don’t have insurance, you might not be able to afford to see a primary care doctor. You also might live far away from a neurologist and, being poor, be less likely to have access to a car, or time to to go and see one. There are so many things that make it harder when your life is already dominated by these violent headaches.
I talked with several migraine sufferers who self-described as low-income. Some had insurance, some didn’t, and some were on Medicaid or Medicare. The majority hadn’t heard of Aimovig. Many of them said they didn’t have a regular migraine doctor; some didn’t have a regular doctor at all.
All of the people I spoke with wished to remain anonymous, with some of their names changed for this story; many migraine sufferers are afraid of their employers finding out about their condition.
L, a low-income migraine sufferer, told me she gets migraines every day; she said she can “usually handle them okay” except for the ones where she loses her vision and can’t drive to work,which happens “a few times a month.” She said she’s currently uninsured, but that when she had insurance, she “briefly” saw a neurologist, though “nothing was very effective.” When I asked her if she thought about pursuing Aimovig—which she hadn’t heard of until I mentioned it—she said, “I’m not sure that I could swing it,” since she’s uninsured.
Her experience echoes what several other women told me. Mary, a 53 year old in Virginia, said she has three adult children who also have migraines. One of her children is autistic, and she lives with him on his Social Security Disability payments and his part-time job. She’s currently training with the Virginia Department of Aging and Rehabilitation to work on a computer from home. She says she has migraines six to seven days a week but has struggled with previous migraine treatments, and “was on opioids from the age of 19 years old until the age of 53 years old,” for both her migraines and her arthritis.
“I’ve been trying for help for a long time.”
I asked Mary if she’d heard of Aimovig. “I haven’t heard of it. I’m uninsured. I’ve been trying for help for a long time,” she said. She’s currently trying to get on Medicaid. Since we started talking for my piece, Mary has seen a doctor and is being sent to a neurologist—and she’s going to ask about Aimovig. Would anyone have told her about it if I didn’t?
Still others just can’t afford to see a doctor or can’t find the time between numerous responsibilities or jobs. Charlie, who works at a coffee shop, said they have insurance but “literally work and attend school to the point of not having time to pursue any kind of prescription” for their migraines; they borrow sumatriptan, the generic form of the migraine drug Imitrex, from their mom to get by.
Rach, who had just left her second minimum-wage job in hopes of getting more hours, said she’s “definitely low income.” She gets migraine with aura, where patients have visual or sensory disturbances before and during a migraine, and “debilitating” nausea. But she isn’t planning to go to a doctor anytime soon. “If I could I would,” she said, but “I need to find a job more than I need that right now.”
Others said they were discouraged from even trying to seek out Aimovig because of previous struggles with getting their treatment covered. Jes, who is 31 but on Medicare because she receives Social Security Disability benefits, told me that having “government insurance does make me wary because I’m tired of jumping through hoops already, but I would for a ‘holy grail’ medication. My biggest hesitation is side effects. I’ve not had good luck with a lot of medications I’ve tried.” But she says that if “a med is worth the side effects for me, I’d theoretically try to jump through all the necessary hoops with insurance.”
“I need to find a job more than I need that right now.”
Tay, a 20 year old student and server in Maine, gets roughly a dozen migraines a month. She said she’s still on her parents’ insurance for now but pays her own co-pays and prescription costs. In the past, she had seen some headache specialists but couldn’t afford to anymore: The co-pay is around $40 each time and the tests she had cost over $700. But she’s also found she doesn’t get taken seriously by regular doctors. Her primary care doctor “typically brushes it off and tells me to drink more water.”
As Tay found, the costs of the kinds of tests that might be required to diagnose migraine can pile up, even for people who are insured. Julia, who lives in Texas, told me she’s seen several doctors about migraines, has tried physical therapy, had an MRI, and is just starting hormone therapy. All of this was very expensive. She sent me a screenshot of her health insurance website’s claims page, showing $32,274 has been billed to her insurance this year, and that her financial responsibility totaled $3,755. Her insurance also costs $712 a month, she said—almost $6,000 so far this year. She said she’s relied partly on Gofundme to help pay for all this. She asked her doctor about Aimovig, but they suggested she pursue hormone treatment first.
Cristine, who’s on Medicaid, was one of the very few people of more than 15 I heard from who had actually been prescribed Aimovig. She’s currently waiting to find out if she’ll be able to get her third dose without a hitch—the company provides the first two free, but she doesn’t know if Medicaid will cover the third dose yet. She said her doctor thought it would be covered “since we could show that we’d tried just about everything else and nothing worked.” Aimovig isn’t helping her so far, but it can take a couple doses before it works. And even if it doesn’t help, at least she was able to try the latest treatment—and she said she hasn’t had any side effects.
Aimovig is covered by many insurers. But if you drill down any further than that, you hit the byzantine maze at the heart of the American healthcare system. There are lots of different insurance companies, each with different plans in different states and different rules for whether and how they’ll approve Aimovig. These rules are part of “prior authorization” requirements. Most of the time, your doctor can prescribe whatever drug (or medical procedure) they think is best, but if your insurance requires prior authorization for that particular drug, the doctor has to get approval from the insurance company before the plan will pay for it. A survey from the American Medical Association found that 92 percent of doctors said prior authorization requirements negatively affected their patients’ outcomes, and the same percentage said it delayed care; nearly a one-third of providers reported waiting more than three business days for approval.
In July, Reuters reported that some insurers, including Blue Cross Blue Shield in Kansas and Florida, would only accept Aimovig prescriptions from doctors certified by the United Council of Neurologic Subspecialties (UCNS), of which there are currently only 484 in the U.S. With almost 40 million migraine sufferers in the U.S., that’s around 80,000 migraine sufferers per specialist. Even if you only included patients who have chronic migraine—more than 15 days per month, which affects around 4 million people in the U.S.—that’s still only one certified headache doctor for roughly every 8,000 patients. Most people with migraine will never be treated by a UCNS certified doctor.
I am lucky enough to live in the District of Columbia, which has the highest ratio of certified migraine specialists to patients; several states, including Kansas, don’t have any at all. A spokesperson for Blue Cross and Blue Shield of Kansas shared a copy of their policy on CGRPs, which says the prescriber should be “a headache specialist (e.g. neurologist, The United Council for Neurologic Subspecialties [UCNS] certified) or has consulted with a headache specialist.” The spokesperson said in a statement to Splinter that that doesn’t mean the doctor has to be UCNS certified. Similarly, a spokesperson for Blue Cross Blue Shield of Florida told me that “the headache specialist isn’t required to be a member of the UCNS, that was just an example of such a group.” (The UCNS certification is the only widely recognized headache specialist certification.)
The other part of these onerous prior authorization requirements is step therapy, also known as “fail first” therapy, which requires doctors to prescribe cheaper drugs first. This is a rough proposition for migraine patients, as each different class of drugs has its own potentially miserable side effects, and most of these treatments fail anyway.
The process is even more Kafkaesque for patients using Medicaid. Ultimately, I couldn’t get a straight answer on whether Aimovig is covered by Medicaid or not. The federal Center for Medicare and Medicaid Services told me that “as long as the drug meets the definition of a covered outpatient drug, states would be required to cover the drug because the labeler is in the Medicaid Drug Rebate Program.” Aimovig meets this definition, so eventually, every state should cover it. But each state’s Medicaid program has a Preferred Drug List, which lists which drugs are “preferred” and “non-preferred”—i.e., requiring prior authorization, just like commercial plans.
And not every state seems to cover it at all yet. While some states like California already cover Aimovig, others haven’t caught up. Arkansas’ PDL doesn’t yet list Aimovig in either category; neither does Kansas’ or Florida’s, but Mississippi’s does. Massachusetts covers it with prior authorization from a doctor. That means, at least for the time being, another set of unknowns for patients on Medicaid who need the drug—whether their state has approved it yet and what kinds of restrictions there might be—and, likely, another set of time-consuming phone calls to try and figure it out.
Some states have also adopted the rationing approaches of their private counterparts. Maine’s Medicaid agency told me the state will only cover Aimovig if the patient has tried three other medications for at least 60 days and found them to be ineffective.
As Medicaid becomes a bigger portion of state budgets—many of which, including Maine’s, are subject to balanced budget amendments legally banning them from running large deficits—it’s unsurprising to see them adopt these short-sighted cost-saving measures (which some research indicates might actually cost the state more because of increased inpatient and emergency room visits).
All of this means many more tiresome bureaucratic hoops for patients and their doctors to jump through just to get this drug. This all makes sense from the prospective of C-Suite healthcare conglomerate executives, because the drug is expensive, and covering it for too many people would eat into their profits, and insurers gotta eat, too.
The drug companies that make Aimovig have their programs to get the drug to those with no insurance and to lower co-pays for people with insurance, which is certainly better than nothing. But it’s no substitute for a just and humane healthcare system, and it shows what an inefficient and patchwork system we have, where expensive drugs have to be subsidized by the manufacturers and rebates, introducing a whole set of extra forms to fill in and delays to deal with. Drugmakers shouldn’t be getting fat off profits while this is happening. For all its generosity with Aimovig Ally, Amgen had a net income of $2.3 billion in the first quarter of 2018, boosted even more by lower taxes. Novartis had profits of $7.7 billion last year.
Migraine sufferers have hard lives. There has been an incredible innovation that can make those hard lives easier. Wouldn’t it be better if the only thing that determined whether or not a migraine sufferer could get Aimovig wasn’t whether their insurance covered it, or whether they could afford it, or whether they saw the right kind of doctor, but simply whether their doctor thought it might help them? Instituting Medicare for All wouldn’t magically create new headache specialists, but it would eliminate this awful subjugation of migraine sufferers’ health needs to the whims and profits of insurers. Medicare for All, and Aimovig for All, too.