Advocacy Group Calls on Insurers to Modify Step Therapy for Migraine Treatment   

By Pat Anson. PNN Editor

The National Headache Foundation (NHF) is calling on health insurers to stop using rigid “step therapy” policies and make it easier for migraine patients to get access to new treatments.

Step therapy is a common practice in the insurance industry to control costs. It requires patients to try cheaper and often older medications first, before “stepping up” to drugs that cost more.   

“For too long, migraine patients have been treated differently than others with medical issues as it relates to access to prescription medications. Specifically, clinicians are often forced to use outdated prescription drugs in a stepwise approach to all patients, without considering the needs of the individual patient,” said Thomas Dabertin, Executive Director/CEO of NHF, a non-profit that seeks to raise awareness about migraine and headache disorders.  

“Unfortunately, the current care models adopted by payers have not kept pace with the many advances in treatment. As a result, clinicians are using older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist.”

Migraine treatment has been revolutionized in recent years by the introduction of neuromodulation devices and drugs that inhibit calcitonin gene-related peptides (CGRP), proteins that cause migraine pain. CGRP inhibitors cost several thousand dollars a year, while neuromodulation devices usually cost several hundred dollars.

Older drugs used to treat or prevent migraine, such as triptans, antidepressants and over-the-counter pain relievers, are much cheaper and often come in generic formulations. Many Insurers require patients to try at least two of the older medications first -- and for months at a time -- before authorizing newer therapies.

“NHF believes it is inappropriate to require all patients to follow this ‘try two and fail’ model before they may be offered treatment with any FDA-approved migraine preventive, including neuromodulation devices, with established lower adverse event profiles,” the NHF said in a position statement.

“For patients who are highly impacted or disabled by migraine, clinicians should not be directed to deliver outdated models of care that apply a predetermined algorithm in a stepwise approach to all patients, without considering the needs of the individual patient, and that encourage the use of older preventive drugs when targeted and migraine-specific therapies now exist.”

The NHF wants insurers to adopt modified forms of step therapy for migraine sufferers, based on the severity of their disease and the frequency of their attacks.

For patients who have seven or fewer migraine days per month, the NHF recommends that patients be required to try only one generic drug for migraine prevention. For patients who experience 8 or more migraine days per month, the foundation recommends that providers have “unfettered access” to FDA-approved prevention drugs.

For the treatment of acute migraine pain, the NHF recommends that two generic drugs be tried first, but if the drugs fail to work within two hours or have unwelcome side effects, providers be allowed to select “another suitable therapy” based on a patient’s needs.  

“The NHF advocates that payers adopt care models that are patient-centric, where the clinician, in collaboration with the patient, is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs,” Dabertin said.

Although the NHF accepts donations from the pharmaceutical industry, Dabertin told PNN the foundation’s new position statement was based solely on input from patients and providers.

‘Golden Era’ for Migraine Therapy Not Providing Relief  

By Pat Anson, PNN Editor

In recent years there have been many advances in treating and preventing migraine – what some have called a “treatment revolution” in migraine therapy. New oral and injectable drugs block a key protein released during migraine attacks, and a novel smartphone-controlled device uses neuromodulation to help ease migraine pain.

But for many migraine sufferers, the increasingly crowded field in migraine therapy isn’t translating into pain relief or improved quality of life. Many are reluctant to seek treatment or take medication, and feel stigma about having the disease, according to two new studies.

“We are in a golden era for migraine care with the introduction of new therapeutic options for both the acute and preventive treatment of the disease, but if we don't address the need for better education, less stigma and improved access to care, we are falling short," said Eric Pearlman, MD, a senior medical director at Eli Lilly.

A survey released by the National Headache Foundation in recognition of Migraine and Headache Awareness Month found that less than a third (29%) of people with migraine feel that their disease is under control. The online survey of over 1,000 men and women diagnosed with migraine was funded by Biohaven Pharmaceutical.

Many respondents are concerned about side effects from the medications they take, such as brain fog, fatigue and sleepiness. Almost half of respondents (47%) between the ages of 18-59 say side effects have interfered with their ability to go to school or work. Nearly as many (46%) feel anxious about taking medication.

And despite the plethora of new choices available in migraine therapies, nearly two-thirds (65%) of migraine sufferers are still using an old medication -- triptans -- as a treatment for migraine pain.

"We must strive to understand and educate about the impact of this disease on not only physical well-being; but also, emotional and mental health," said Mary Franklin, executive director of National Headache Foundation. "Every person living with migraine has a different experience and we want all to feel confident in their treatment choices; but also know that there are others who understand the real impact of the disease."

The survey asked migraine sufferers about the emotional and mental burden of the disease, and the impact it has on daily life.

  • 77% said they were not able to do the things they wanted to because of migraine attacks 

  • 54% feared they were a burden to family, friends and colleagues

  • 53% say they modified career plans due to migraine

  • 42% were unable to exercise or engage in physical activity

  • 37% feel less productive at work or school

  • 28% feel less able to take care of their children

  • 25% avoid sexual intimacy

The vast majority of respondents (93%) feel misunderstood and that those who don't suffer from migraine don't understand the severity of their disease.

OVERCOME Study

Results from the Biohaven survey were echoed in a large new study of more than 21,000 people living with migraine, which found that less than 30 percent are taking a recommended prescription medication.

"For millions of people living with migraine, the journey to an appropriate treatment program is fraught with gaps," said Susan Hutchinson, MD, scientific advisor to the OVERCOME study. "There are a variety of reasons at play, but it begins with the fact that many may not realize what they are experiencing is a migraine and not just 'another bad headache.'”

The OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine) study was funded by Eli Lilly. It sought to assess the impact of new treatment options and whether migraine sufferers completed three critical steps in migraine management:

  1. Actively sought care with a healthcare professional

  2. Received a migraine diagnosis

  3. Took a recommended prescription medication

Less than two-thirds (63%) of those who may benefit from acute migraine medication sought treatment from a healthcare provider. Of those, 75% were diagnosed with migraine. Among the diagnosed population, only 59% percent took a recommended drug. Overall, only 28 percent completed all three steps to appropriate care.

The results weren’t much better for OVERCOME respondents who may benefit from a migraine prevention drug. A little over two-thirds (69%) sought care and 79% received a migraine diagnosis. Of those who sought care and received a diagnosis, only 28% wound up taking a preventive medication for migraine. Overall, only 15 percent of this population completed all three steps to appropriate care.

Some migraine sufferers only seek treatment when their pain become unbearable. About 10% of respondents sought care in an emergency room or urgent care clinic setting, where they are less likely to receive an accurate diagnosis or take a recommended medication. 

"Even in light of recent new treatment options in the field of migraine, we still face an uphill battle as too many continue to be underserved," said Robert Shapiro, MD, a scientific advisor to the OVERCOME study. "An important aspect of migraine care that is truly diminished and may contribute to these findings is the stigma felt by many living with the disease. A person's reluctance to seek care or take medication for their migraine can be rooted in the fear of how a friend, employer, or even a loved one may view them for doing so."

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses.