For CAR approved article (OVERCOME)

Real-World Evidence: The Role of Patient Population Surveys to Improve Care in Migraine

Eli Lilly and Company  | October 9, 2020

Tags |  Chronic Pain, Pain

This guest article comes from Michael Cobas Meyer, vice president, global medical affairs, Lilly Bio-Medicines.

Migraine is the second leading cause of disability worldwide and has an enormous impact on people living with this neurologic disease. Migraine attacks can be severely burdensome, intensely painful and debilitating, often interfering with daily activities, such as work and time with friends and family. According to the International Burden of Migraine study, nearly four out of five (79%) people with migraine reported experiencing severe pain during a migraine attack.

Population-based studies also show that around two of every five people with migraine are not able to effectively work or spend time with family or friends due to migraine at least one day a week. In the U.S., it is estimated that more than 157 million workdays are lost each year due to migraine and that health care costs associated with migraine are as high as $56 billion annually.

Migraine is a complex disease, and there is no one-size-fits-all approach to treating migraine. That’s why continued research is necessary; it advances our understanding of the disease and its management, and can lead to new treatment alternatives. Outside of clinical controlled trials, so-called real-world evidence can provide equally important insights. For example, observational, population-based surveys may include people who are seeking or not seeking care, diagnosed or undiagnosed with migraine, and treated or not treated with recommended acute and preventive medications for migraine and that capture participants’ experiences yield insights that cannot be captured in clinical trials. So real-world evidence can ultimately improve our understanding of disease management, and identify opportunities to improve migraine care, taking into consideration what matters most to patients.

At this year’s Migraine Trust International Symposium (MTIS), we presented the latest findings from our OVERCOME (Observational Survey of the Epidemiology, Treatment, and Care oMigraine) study. OVERCOME, which will enroll over 100,000 respondents with migraine from regions throughout the world including more than 60,000 participants in the U.S., will be the largest population-based real-world study of its kind by including U.S. patients who are studied over time. OVERCOME aims to further understand the unmet need of those with migraine by assessing the burden experienced by people living with this debilitating and painful neurologic disease and identify barriers to the appropriate treatment of migraine. In addition, OVERCOME is assessing how the introduction of novel treatment options, including the class of CGRP monoclonal antibodies (mAbs), may influence the delivery of migraine care and outcomes.

The data from U.S. OVERCOME reported at MTIS showed nearly 80% of people reported improvement in their migraine since starting a CGRP mAb for preventive treatment of migraine. In other words, four out of five people who use these innovative medications report benefiting from them. Health care providers can use this information as part of their conversation with patients about potentially effective migraine prevention treatments.

OVERCOME also provides important insights into the unmet need of people with migraine. Results shared earlier this year at the American Headache Society’s 2020 Virtual Annual Scientific Meeting found that approximately one in three people impacted by migraine, who actively sought care with a health care professional and received a migraine diagnosis, had been recommended an acute prescription medication to take for a migraine attack. Less than one in five people with migraine eligible for preventive treatment had been recommended a preventive prescription medication. These findings highlight that despite the availability of novel treatment options for migraine, significant opportunities exist to optimize treatment among people with migraine. Whether it’s due to not recognizing and/or diagnosing migraine, ineffective patient-provider communication regarding the impact of migraine on the patient’s life, or societal influences such as stigma, more needs to be done to ensure people with migraine are informed about their disease and aware of their treatment options and treatment outcomes they may achieve.

OVERCOME is capturing real-world data during an era when several novel preventive and acute medicines for migraine are being made available to patients and practitioners. The study is helping assess the influence of these novel therapies on how health care providers prescribe medications for migraine, as well as capturing the patient’s experience through patient-generated data about care-seeking, treatments used for migraine, the impact of migraine, and patient-reported outcomes. Together, these data will address critical scientific and clinical questions during this unprecedented time of new treatment options for those living with migraine.

At Lilly, we are committed to going beyond clinical trials to advancing findings for migraine management. We believe that insights from OVERCOME will be useful to health care providers to help people with migraine make informed, empowered decisions in light of the outcomes they seek. Learn about options for preventive and acute treatments for migraine.