A new study shows that FDA-approved oral migraine drug atogepant is effective for relieving difficult-to-treat “medication overuse headaches” that are the result of using too much of other pain relieving medications. However, patients often have to jump through hoops to get it covered by their insurance company.
Migraines affect nearly one in eight adults in the U.S. Migraines are also the leading cause of disability in adults under 50 years of age. in the United States. This high number underscores the need for better treatments for people with migraines.
Atogepant, marketed under the brand Qulipta by the company AbbVie, is part of a new class of migraine medications known as CGRP inhibitors, so named because they block a protein called calcitonin gene-related peptide (CGRP), which has been found to be a cause of migraines.
Qulipta is one of only two FDA-approved CGRP inhibitors taken as a pill for the prevention of migraine headaches, the other being rimegepant, marketed as Nurtec by Pfizer. All other drugs in this class used for migraine prevention are injectables.
The American Headache Society’s (AHS) recently released a position statement says that CGRP inhibitors should be the first treatment a doctor prescribes for migraines. But Insurance companies often require patients to go through a process known as “step therapy” where they have to try less expensive interventions before they can get access to Qulipta or one of the other CGRP inhibitors.
“CGRP-targeting therapies, unlike most other migraine treatments that were "borrowed" from other indications like antidepressants, blood pressure medications or seizure medications, were developed specifically to treat migraines based upon a solid foundation of evidence,” according to Dr. Andrew Charles, professor of Neurology at UCLA and lead author of the American Headache Society's position statement.
Step therapy requires patients to try a series of cheaper drugs first, even if they are less efficient and cause more side effects, before they are approved to receive one of the newer treatments. The goal of step therapy is to control costs, but it can also end up delaying proper treatment and patients often find it frustrating and time-consuming because they must needlessly go through several medications before they can get ones that work.
"Step therapy, or fail first requirement, is a no-win situation for people like me living with migraines. For me, using medications that were known to be less effective delayed necessary treatment, and led to worsening disability and chronification of my migraine disease," says Nancy Harris Bonk, a migraine patient and advocate.
Congress has proposed a bill potentially banning step therapy when it is unsafe, which its often the case for migraine patients.
“It is no surprise that medication costs are a barrier for patients to access these treatments despite this position paper, and a major goal for all of us is to reduce drug costs for patients and the system,” Dr. Matthew Robbins, associate professor of neurology at Weill Cornell and president-elect of the AHS, told ABC News. “However, our primary goal is always to get the right treatments to the right patients, so we are hopeful that the position statement will move along insurance companies, pharmacy benefit managers, and other systems of care to improve access in addition to cost reductions for these medications.”
For example, AbbVie offers a program to help with the expense of the Qulipta by providing a savings card and patient assistance program that can reduce out-of-pocket costs for eligible patients, including those on Medicare and Medicaid.
Pfizer, the makers of Nurtec, offer a similar savings and assistance program but only for those on private insurance plans. People on Medicare and other government-funded insurance may wind up paying high out-of-pocket costs.
"Many patients and healthcare providers are not aware of the patient assistance program offered by Abbvie or other companies. Additionally, pharmacies often do not accept co-pay cards or coupons offered by the manufacturer, which leaves many patients without access to necessary medications," said Dr. Hida Nierenburg, a board-certified neurologist and headache specialist at Nuvance Health.
"Although they are expensive, some insurers are now acknowledging that the overwhelming evidence supporting their efficacy, tolerability, and safety warrants consideration as a first line treatment for the prevention of migraine” says, Dr. Charles.
Keerthana Kumar, MD, MPH, a licensed and practicing headache specialist at Nuvance Health/Vassar Brothers Medical Center, is a member of the ABC News Medical Unit.