Chronic Migraines: Improving Outcomes

St. Louis—It is estimated that the population prevalence of chronic migraine (CM) in the United States is from 1.4% to 2.2%. CM is a complication of migraine and is defined as ≥15 headache days per month and at least 8 headache days per month meeting the criteria for migraine without aura or responding to migraine-specific treatment. CM is one of the most disabling primary headache disorders, imposing considerable economic and social losses; it remains a challenge for neurologic and headache practices to treat and manage. At a satellite symposium at the AMCP meeting on Improving Health Outcomes in Chronic Migraine: Obviating Medication Overuse/Applying Clinical Guidelines and Novel Data, Dawn C. Buse, PhD, provided attendees with an overview of the disease in a presentation titled Defining the Impact of Chronic Migraine: Diagnosis, Epidemiology, and Burden of Illness. Dr. Buse is assistant professor in the department of neurology at the Albert Einstein College of Medicine of Yeshiva University, New York, New York. Dr. Buse opened her presentation by noting that CM “is burdensome, underdiagnosed, and undertreated.” CM often develops from episodic migraine (EM) following an increase in headache frequency. Progression to CM is associated with several risk factors, including some that cannot be modified, such as age and race, and others that are potentially modifiable or avoidable, such as obesity, snoring, head injury, stressful life events, depression, and overuse of opioids and barbiturates. She continued by outlining the changes in the definition of CM over the past 15 years. In 1996, the definition developed by Silberstein and Lipton was the accepted descriptor; in 2002, the International Classification of Headache Disorders revised the criteria for diagnosis of CM (ICHD-I); a further revision was issued in 2006 (ICHD-II). The ICHD-II criteria for diagnosis of CM are migraines that occur ≥15 days per month and are of ≥4 hours in duration. According to Dr. Buse, clinical and population-based studies have shown that in comparison with EM, CM causes increased migraine-related disability, reduced health-related quality of life (QOL), increased utilization of health-related resources, and additional medical and psychiatric comorbidities. She reported on a cross-sectional analysis of data from the American Migraine Prevalence and Prevention (AMPP) study published in 2010 in the Journal of Neurology, Neurosurgery, & Psychiatry. The analysis revealed that compared with patients with EM, those with CM were significantly less likely to be employed full-time and nearly twice as likely to be occupationally disabled. Patients with CM were also twice as likely to have anxiety, chronic pain, or depression. They also had higher risk of cardiovascular and respiratory disease, were 40% more likely to have heart disease and angina, and 70% more likely to have a history of stroke. The 2005 AMPP reported on 11,094 patients with EM. Of those, 83% (n=6805) remained at the EM level; 2.5% (n=209) progressed to CM. The remaining 14% (n=1205) had other outcomes. Data from the AMPP revealed that patients with CM were 19% less likely to be working for pay compared with migraineurs with ≤3 headaches per month, and CM patients lost, on average, 4.6 hours per week due to headache compared with patients experiencing ≤3 headaches per month. When taking medical leave and unemployment into consideration, while patients with 10 to 14 headaches per month or with diagnosed CM represented 9.1% of employed migraineurs, they accounted for 20.8% of work-related lost production time and 35% of overall lost work time, according to findings in the AMPP study. Dr. Buse concluded her presentation with data from MIDAS (Migraine Disability Assessment Scale) that included self-reported patient costs. Patients with CM (n=655) reported monthly medication costs of $75.12 for acute medications and $19.93 per month for preventive medications, compared with patients with EM (n=11,249), who reported costs of $32.99 for acute medications and $6.62 for preventive medications. Clinical Trials in CM The symposium continued with a presentation from David W. Dodick, MD, Clinical Trials in Chronic Migraine: Interpreting the Results and Lessons Learned. Dr. Dodick is professor of neurology at the Mayo Clinic College of Medicine and a consultant in neurology at the Mayo Clinic, Scottsdale, Arizona. Dr. Dodick began his presentation by noting that managing CM requires a multifaceted approach that includes lifestyle modification, trigger avoidance, behavioral therapy, pharmacotherapy, patient education and support, management of expectations, and intense follow-up. He noted that pharmacologic interventions are often needed for long-term prophylaxis of CM. He continued by saying that the use of opioids and analgesics to treat CM can lead to medication overuse. Estimates of the prevalence of medication overuse among patients with CM range from 30% to 80% of CM patients in the United States. He stressed that migraine is a neurologic disorder, not a primary headache disorder, and that “patients with CM are extraordinarily disabled.” CM was diagnosed only recently and there have been 2 revisions to the initial definition; Dr. Dodick said that the definition of CM is a “moving target” and that there have been only a few randomized controlled trials (RCTs) and no US Food and Drug Administration–approved drugs for treatment. The lack of evidence base coupled with the lack of approved drugs creates challenges for CM prophylaxis and management. There have been RCTs on topiramate, divalproex, and onabotulinumtoxinA for prophylactic treatment of CM, but more well-designed placebo-controlled studies are needed to assess the effectiveness of pharmacologic treatment options for CM, according to Dr. Dodick. He outlined guidelines for trial design, using the number of headache days with moderate or severe headache and the number of migraine days as primary end points. Two recent trials of topiramate (1 in Europe and 1 in the United States) both met their end points, according to Dr. Dodick. He continued by saying that putting patients with CM on prophylactic medications will cut costs for acute medications. He outlined results from a pooled analysis of the PREEMPT 1 and 2 (double-blind, randomized, placebo-controlled Phase III Research Evaluating Migraine Prophylaxis Therapy) studies. The primary measure in both studies was frequency of headache days. Patients treated with onabotulinumtoxinA (n=688) had 8.4 fewer headache days compared with 6.6 fewer days for patients treated with placebo (n=696; P<.001 dr.="" dodick="" said="" that="" topiramate="" is="" currently="" approved="" for="" migraine="" management="" and="" has="" been="" evaluated="" of="" cm.="" trial="" results="" to="" date="" have="" shown="" be="" effective="" safe="" well="" tolerated="" in="" specific="" patient="" populations.="" there="" however="" serious="" adverse="" effects="" inadequate="" efficacy="" some="" patients="" leading="" poor="" adherence.="">Future Clinical Guidelines The symposium continued with a presentation from Matthew P. Mitchell, PharmD, MBA. Dr. Mitchell, manager of pharmacy services for SelectHealth and a staff pharmacist in Salt Lake City, Utah, spoke on Outcomes Associated with the Treatment of Migraine Headaches in a Managed Care Setting: Directions for Future Clinical Guidelines. Dr. Mitchell opened his remarks by noting that migraine is one of the most common reasons patients seek healthcare. Migraine patients account for 10 million office visits each year in the United States. However, only 3% to 5% of patients with migraines receive preventive treatment. According to Dr. Mitchell, use of therapeutic prophylaxis for migraines reduces overall treatment cost. He cited a 2005 study of patients receiving triptan for migraine (n=8488) that revealed overuse of the medication contributed to headache frequency. When a health plan limited the use of triptan to 9 doses per month, there was no increase in migraine-related visits to the emergency department (ED), frequency of headaches, or medical costs. The study also found that new triptan users utilized fewer triptan unit equivalents compared with patients taking triptan continually. These results may lead to early identification of high users of migraine treatment and the development of a cost-effective intervention program increasing the use of migraine prophylaxis in appropriate patient populations, Dr. Mitchell said. He then cited a study designed to determine whether treatment with botulinum toxin positively affects QOL measures, utilization, and cost outcomes to help inform coverage decisions related to medication use and migraine-related ED visit costs. The study was based on administrative claims data and a QOL survey. Patient selection was based on at least 1 medical claim from a neurologist and International Classification of Diseases, Ninth Revision codes for migraine, tension headache, or headache. Administrative claims data were used to identify which patients used botulinum toxin, identified by the Healthcare Common Procedure Coding System billing codes for botulinum toxin type A or botulinum toxin type B. The study conclusions included the following: of the treatment-resistant patients taking botulinum toxin, 73% who responded to a mailed survey reported improvement in 6 measures of QOL. There was a 50.5% increase in use of overall migraine-related medication (primarily analgesics) when comparing the 18-month periods prior to and following treatment with botulinum toxin. There was no significant change in ED visits from the 18 months prior to treatment with botulinum toxin to 18 months after treatment. In conclusion, Dr. Mitchell said that patients with high-frequency EM or CM represent a difficult-to-treat population. The patients are expensive to treat, requiring frequent visits to specialists, combination pharmacologic therapy, and frequent ED visits. He stressed the need for new algorithms of care, noting that there are very few medications for the management and treatment of CM in the drug pipeline.—Tori Socha