FDA on Thursday approved the first in a new class of drugs designed to prevent migraines in adults—a move that some providers said could revolutionize patient care.
According to the New York Times, an estimated 37 million U.S. residents experience severe headaches known as migraines, with approximately 2.8 million U.S. residents experiencing several migraines each month. Migraines are three times more frequent among women than men and are more prevalent among people ages 35 to 55 than those in other age groups, the Wall Street Journal reports.
Individuals who experience migraines typically describe the pain they feel "as an intense pulsing or throbbing pain in one area of the head," according to FDA. In addition to feeling pain, such individuals sometimes experience symptoms such as difficulty speaking, nausea, and sensitivity to light—and their symptoms can last for hours or days, the Times reports. According to the Times, individuals who experience migraines historically have used treatments designed for other conditions, such as seizures or high blood pressure, to prevent migraines. Examples of such treatments include Allergan's anti-wrinkle injection Botox and generic hypertension and anti-depressant medications, Reuters reports.
FDA approves first-of-its-kind treatment for migraine prevention
FDA approved Aimovig, which is produced by Amgen and Novartis, for monthly use in adults. The drug is self-administered using an auto-injector similar to an insulin pen. According to FDA, the drug blocks "activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks."
FDA said it approved Aimovig based on results from three clinical trials involving a total of 2,199 patients. In all three trials, Aimovig lowered the incidence of migraines more than placebos. In the first trial, which involved 955 patients with a history of migraines, those who took Aimovig for six months reported one- to two-fewer migraine days on average when compared with those who took a placebo. In the second trial, which involved 577 patients, those who took Aimovig over three months reported having an average of one-fewer migraine day per month when compared with those who took a placebo, and in the third trial, which involved 667 patients, those who took Aimovig over three months reported on average 2.5-fewer migraine days per month when compared with those who took a placebo.
FDA said the most common side effects reported by patients involved in the trials were constipation and reactions at the injection site.
Amgen said it expects Aimovig will be available in the U.S. market within a week.
Amgen in a release said Aimovig's list price in U.S. market will be $575 a month or $6,900 annually for both the 70 milligram and 140 mg doses. The company said the price "reflects the value it brings to patients and society."
Amgen said it will launch the Aimovig Copay Program, through which the company will "help reduce a patient's out-of-pocket costs to as little as $5 per month for eligible patients with commercial insurance." Amgen added that patients' "out-of-pocket costs" for the drug "will vary depending on insurance status." Amgen spokesperson Kristen Davis added that discounts or rebates for the treatment would depend on negotiations with insurers.
According to Reuters, some Wall Street analysts had expected Aimovig's list price to be set at $10,000 per year. Michael Yee, a Jefferies analyst, said Amgen's pricing strategy for Aimovig "appears to play into (an) appropriate framework of lower gross pricing." According to Reuters, analysts forecast Aimovig will generate sales of nearly $1 billion by 2022.
The pharmacy benefit manager Express Scripts said the company will establish a program to ensure only patients who need the treatment receive Aimovig. Express Scripts suggested that, if the drug does not work, Amgen should provide at least partial refunds, noting that many patients enrolled in the clinical trials did not report a significant improvement in symptoms.
Some tout Aimovig as 'revolutionary' migraine treatment
Eric Bastings, deputy director of the division of neurology products in FDA's center for drug evaluation and research, said, "Aimovig provides patients with a novel option for reducing the number of days with migraine," adding, "We need new treatments for this painful and often debilitating condition."
Sean Harper, Amgen's executive vice president of research and development, said FDA's "approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine."
According to the Journal, physicians have said Aimovig and other treatments in its drug class will change the lives of patients who experience migraines.
Tareck Kadrie, a neurologist, said, "We think it's going to revolutionize treatment in migraines," noting that clinicians typically prevent migraines in patients by using drugs designed for other conditions.
Amaal Starling, a neurologist and migraine specialist at the Mayo Clinic, said, "The drugs will have a huge impact," adding, "This is really an amazing time for my patient population and for general neurologists treating patients with migraine."
But some providers had a more reserved reaction, the Times reports.
Elizabeth Loder of Brigham and Women's Hospital and Matthew Robbins of Montefiore Medical Center in an editorial published in JAMA wrote that Aimovig and other drugs in its class represent "progress, but not a panacea" for patients with migraines. For instance, they wrote that patients "with previous failure of as few as two preventive medication classes for migraine were excluded from" at least one of the clinical trials. "This means the results of this trial may not necessarily apply to patients with severe, treatment-resistant migraine, who are the patients most likely to be prescribed and have access to these treatments in clinical practice" (Kolata, New York Times, 5/17; Greenwood, The Hill, 5/17; Burton, Wall Street Journal, 5/17; Beasley, Reuters, 5/17; FDA release, 5/17; Loder/Robbins, JAMA, 5/15; Amgen release, 5/17).
Advisory Board's take
By Sarah Musco, Senior Consultant, Service Line Strategy Advisor Neuroscience Team
This approval should be seen as good news for providers who have consistently struggled to help the estimated three to seven million Americans that suffer from chronic migraine. In our research, we have heard from many providers that their resources are often strained by headache patients.
This strain is perhaps most obvious in the ED. From 2009-2010, headache was the fourth-leading cause of ED visits, but ED providers consistently lack the time or specialized training needed to provide comprehensive headache care. As a result, patients are often referred to outpatient neurologists where they face long appointment wait times due to the widespread neurologist shortage—and a dearth of specialized headache clinics.
This new treatment option could ease those capacity issues by allowing more lower-acuity migraine patients to improve their symptoms while being treated by their primary care provider (PCP), as opposed to needing specialized care. But given the limited efficacy and newness of the drug, it's hard to predict how it may change care. We would suggest that providers consider two actions when considering their response to this new treatment:
- First, we anticipate that this new medication will allow more lower-acuity migraine patients to improve their symptoms while being treated by their primary care provider (PCP), as opposed to needing specialized care. Therefore, headache programs should adopt an effective triage protocol to ensure that only the patients who have not already tried this new medication with their PCP are scheduled to meet with a specialist in their program. This triage protocol can, ideally, reduce the burden on headache programs and lessen specialist burnout.
- Second, we suggest that headache programs emphasize PCP education on both this new medication and on appropriate headache care referrals. Many programs we spoke to, which were struggling to meet surging patient demand, were able to reduce inappropriate referrals by offering educational sessions to PCPs.
To learn more about the three most important imperatives to meet headache demand, and four successful headache program models, read our executive brief on managing demand for headache care.