‘This is huge’
FDA drug approval could revolutionize migrane treatment for millions
Every week for the past two years, Melissa Henthorn has driven an hour to West Penn Hospital in Bloomfield to receive 20 injections in her head and neck. Until now, it was the only way to keep the headache pain away. But soon, she’s hoping that won’t be necessary.
This week, she’ll receive a prescription for Aimovig, the first drug designed to prevent a migraine — an often debilitating condition that affects 38 million people in the U.S. Created by the pharmaceutical companies Novartis and Amgen, it was approved by the Food and Drug Administration earlier this month.
Since she was 7, Ms. Henthorn, 44, of Slippery Rock, has sought treatment for her severe chronic migraines.
“We’ve never had something like this before,” said Dolores Santamaria, director of the Allegheny Health Network Headache Center, holding the new drug in her hands. “We’re making history right now.”
For Ms. Henthorn, a stay-at-home mom, dealing with migraines has been a tumultuous journey. She’s seen a “truckful” of neurologists and tried dozens of medications. A few years ago, she even had to visit the hospital. After a bad migraine attack, she rushed home, and soon her eyesight began to flicker. One side of her body began to droop, so her husband had to carry her. The ER doctors thought she had a stroke.
“You feel like your head is on one side of your body, and you’re on the other,” she said.
For now, Ms. Henthorn’s treatment of 20 weekly nerve block injections has reduced her migraines to a few times a week. She also receives two other injections and two
pills.
Aimovig, also administered by injection, will likely reduce the frequency even more, and she may not need additional medication. Instead of weekly doctor visits, she’d be able to self-administer the drug, with potentially just one appointment per year. Results from the clinical trials demonstrate a reduction rate of about 50 percent, but a few “super responders” have seen further reductions. Some patients became nearly migraine-free.
“I can’t even conceptualize what’s it like to not be in constant pain,” said Kelly Lynn Thomas, a patient at UPMC. “So, the possibility of having time where I’m not in any pain is mind-blowing.”
For years, Ms. Thomas, 31, of Spring Hill-City View, has written a blog, “The Adventures of Miss Migraine.” The most recent post features the new drug. “Guys. This is huge,” she begins.
In the same blog post, she documented her treatment history — eight different drugs with a slew of unwanted symptoms. Dry mouth, weight gain, insomnia, anxiety, sexual dysfunction, heart palpitations, and the list goes on.
Nationally, 85 percent of migraine patients stop taking medication within a year due to the side effects. But with Aimovig, researchers have documented only one minor side effect, irritation surrounding injection area.
Many of the current drugs used by Ms. Thomas and Ms. Henthorn were not created with migraine patients in mind. They’ve taken pills that were intended to be antidepressants and anti-seizure drugs. Botox was another possibility.
“Just the fact that someone designed a drug to treat migraines is huge,” Ms. Thomas said.
Thefirst wave of migraine specific medication was introduced in the ‘90s, with a class of drugs called triptans. However, an abortive triptans medication are only — ones that halt migraines after they’ve begun, but don’t help with prevention.
Aimovig is a new class of drug, a “monoclonal antibody” that targets a specific compound of amino acids, known as a peptide, that’s associated with migraines.
The release of Aimovig to the market begins a “second wave” of migraine-specific medication, said Robert Kaniecki, director of UPMC’s Headache Center.
UPMC’s Headache Center is one of the busiest in the country, treating about 1,200 patients per month and mostly migraine sufferers, said Dr. Kaniecki, who has been alerting his patients about the potentialthe new drug for nearly a year. The drug, however, comes with a hefty price tag — $6,900 a year. “For me, it would be a first-line agent, if it weren’t for the cost structure,” Dr. Kaniecki said. Some of his patients are willing to pay out of pocket, claiming it’s well worth every penny for reducing their migraines. Ms. Henthorn said she will find out soon if her insurance, Highmark BlueCross Blue Shield, will cover the cost. A company representative stated that, while circumstances depend on a patient’s benefits and appropriate treatment, the drug is on the Highmark formulary and eligible for coverage. Ms. Thomas, however, may have to wait longer. Her UPMC insurance doesn’t cover the medication. For now the medication is “currently under review,” for UPMC said Health a spokeswoman Plan. Anticipating such concerns, Amgen and Novarits have launched the Aimovig Ally product support program to help patients navigate insurance coverage and work toward lower prices. The Aimovig Copay Program, which advertises prescription costs as low as $5 a month. Medicare and Medicaid patients, however, do not apply. Another offer would allow patients to try Aimovig free for two months, if they enroll by the end of the year.
“Even though I’m in a pretty good place with my migraines right now, that’s a tenuous place,” Ms. Thomas said. “I could back slide at any moment.” Weather can be a major trigger. While rain is a minor inconvenience for many people, barometric pressure changes can ramp up the womens’ migraine attacks.
Officials from the UPMC Headache Center soon plan to meet with Amgen and Novartis representatives to discuss patient access and price-reduction Despite the programs. delays, Ms. Thomas is optimistic.
“Knowing that there’s something now that might work in the long term is really exciting,” Ms. Thomas said. “And it gives me hope that I haven’t had in a long time.”