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Golden L. Peters, PharmD, BCPS
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Sheldon J. Rich, PhD, RPh
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Burden of Migraine and Impact of Emerging Therapies on Managed Care

Sheldon J. Rich, PhD, RPh
Migraine is a highly prevalent neurological condition with substantial impact on individuals through associated complications, comorbidities, and increased healthcare costs. The burden on society is likewise substantial via increased healthcare costs and greater indirect costs, such as lost productivity. Research about the pathophysiology of migraine has led to the introduction of a new class of drugs, calcitonin gene-related peptide (CGRP) inhibitors. Current drugs in this class are biologics, which are often accompanied by high prices. A highly competitive and rapidly evolving market landscape is being shaped by biopharmaceutical manufacturers and managed care payers. With an understanding of the societal impact of migraine and the potential impact of CGRP biologics, healthcare providers and managed care professionals should be prepared to develop policies and procedures to ensure appropriate patient access to new therapies.
Am J Manag Care. 2019;25:-S0
Burden of Migraine

Individual and Societal Burden

The burden of migraine takes many forms and, by several measures, makes a substantial global impact by causing considerable disability. Estimates on the annual direct costs of migraine in the United States range from $9 billion to $28 billion.1-3 The ranking of migraine in the Global Burden of Disease (GBD) survey in terms of years lived with disability (YLDs) has increased steadily from 19th in 2000 to sixth in 2013 and to second in 2016.4-6 When focusing on disability-adjusted life-years (DALYs) in people between the ages of 15 years and 49 years, migraine ranked as the third cause of disability in 2015 and first in 2016.5,7 The increase in global YLD ranking may be a result of better and more comprehensive data collection rather than an increase in prevalence5; however, with improvements in data, the impact of migraine becomes more apparent. In 2016 alone, an estimated 1.04 billion people worldwide experienced migraine and contributed to 45.1 million YLDs.6,8

Results from the American Migraine Prevalence and Prevention (AMPP) Study and other surveys provide context about migraine in the United States. The AMPP study results determined that the 1-year prevalence of migraine in adults aged 15 years to 59 years was 11.7%, with a higher prevalence in women (17.1%) compared with men (5.6%).9 Other surveys, such as the National Health Interview Survey (NHIS), the National Health and Nutrition Examination Survey, the National Ambulatory Care Survey, and the National Hospital Ambulatory Medical Care Survey, combined migraine with severe headache data,10 which may overestimate the prevalence of migraine. A closer look at data within the various surveys can highlight certain trends. Women consistently exhibit higher prevalence of migraine and severe headache compared with men.9,10 Age is also a factor, with prevalence appearing to peak in middle age, particularly for women.9 The effect of socioeconomic status should also be considered when addressing the impact of migraine. Both the AMPP and the NHIS indicate that lower socioeconomic status coincides with an increased prevalence of migraine (AMPP)11 and migraine or severe headache (NHIS).10

Direct and Indirect Costs

As expected with a condition of such extensive prevalence, direct and indirect costs of migraine are substantial. In recently published papers, total direct annual costs per patient were estimated to be between $11,0101 and $13,032,12 and both estimates were significantly greater than controls without migraine by $65751 to $9798.12 Bonafede et al compared their results to previously published data that used similar methods. Adjusting for inflation, Bonafede et al estimated a $6575 incremental direct cost due to migraine, which was 1.82 times greater than the previous estimate of $3609 by Hawkins et al.1 With the higher estimated direct costs, Bonafede et al estimated the annual direct costs of migraine in the United States to be at least $28 billion,1 which is greater than other estimates of annual direct healthcare costs that range from $9.20 billion3 to $11.07 billion.2 Direct costs may also be affected by chronic versus episodic migraine status. Patients with chronic migraine may incur $3238 more in annual direct costs compared with patients with episodic migraine,13 suggesting that individuals who experience chronic migraine drive the bulk of migraine costs. Although the estimates may vary, the impact of multibillion–dollar annual direct healthcare costs is staggering.

The indirect costs of migraine are also substantial, with annual estimates similarly in the billions of dollars. Hawkins et al acknowledged that their estimate of annual indirect cost of $12 billion is likely an underestimate primarily because presenteeism was excluded in their analysis.14 Annual indirect costs on a per-patient basis were similarly greater in the migraine cohorts versus controls by $2350, with $11,294 in indirect costs for patients with migraine compared with $8945 in indirect costs for control patients.1 The patient’s status of chronic or episodic migraine also contributes to differences in indirect costs. A study by Munakata et al estimated that the costs of lost productivity per person per year was $5392 for patients with chronic migraine compared with $978 for patients with episodic migraine for an incremental cost of $4414.15 On the other hand, Messali et al reported a more modest difference, with $2357 in incremental annual indirect costs for patients with chronic migraine ($3300) compared with patients with episodic migraine ($943).13 Overall, Messali et al determined that total, direct, and indirect costs were all significantly greater in chronic migraine compared with episodic migraine.13

Work Productivity: Absenteeism and Presenteeism

Loss of work productivity in the forms of absenteeism and presenteeism (working while sick/impaired) represents the indirect costs of an illness. As described previously, indirect costs due to migraine are upwards of $12 billion, excluding presenteeism concerns.14 Presenteeism, however, can contribute substantially to indirect costs of migraine. Another annual estimated indirect cost (in 1999 USD) of $13.3 billion attributed $7.9 billion to absenteeism and $5.4 billion to diminished productivity.16 In a survey study, respondents indicated that 64% of migraines occurred during weekdays and, of those weekday migraines, 68% interfered with work productivity in absenteeism, presenteeism, or both. Study results also suggest that presenteeism accounted for more work-hours lost (1470 work-hour equivalents) compared with absenteeism (1169 work-hours).17 Individuals with migraine may miss an additional 4 to 8 workdays per year, but appropriate treatment may reduce the losses in worker productivity.16,18 The relative contribution of presenteeism versus absenteeism may be an important factor in addressing certain impacts of migraine, but the overall magnitude of indirect costs may be more important to consider.

Personal Life Impact

Per the GBD, migraine ranked second in YLDs in 20166 and contributed to 45.1 million YLDs.6,8 With that magnitude of disability, the impact on the lives of individuals can be difficult to overestimate. Health-related quality-of-life (HRQOL) surveys, including headache- or migraine-specific tools (eg, the Migraine-Specific Quality of Life Questionnaire Version 2.1 [MSQ]),19 serve to help frame the effect of migraine on individuals. Individuals with migraine scored lower on HRQOL surveys compared with the control participants,20 and patients with chronic migraine tended to score lower on HRQOL parameters compared with patients with episodic migraine.21,22 Researchers are also becoming interested in the impact of the condition on family members of individuals with migraine23 as well as the effect of treatment modalities on HRQOL.24,25

Employment issues may also be considered a component of the personal life impact due to migraine. In their study of direct and indirect costs, Messali et al observed that a lower percentage of individuals with chronic migraine are employed (full- or part-time) compared with patients with episodic migraine (49.5% for chronic vs 60.5% for episodic).13 The authors acknowledge that the opportunity cost of unemployment is not adequately captured in indirect cost analysis and they suggest that this opportunity cost may be substantial.13 Considering the role of work life in modern society, the opportunity cost may extend beyond economic costs to impact an individual’s personal life. Whether employment costs, healthcare costs, quality of life, or comorbidities, the effects of migraine on an individual’s life can be substantial, and healthcare providers should be mindful of the myriad ways that migraine impacts patients.

Comorbidities

In addition to QOL issues, a number of comorbidities can accompany migraine. Psychiatric conditions that often occur along with migraine include depression, anxiety disorder, and bipolar disorder.22,26,27 Other comorbidities include fibromyalgia, restless legs syndrome, and epilepsy, among others.26 The issue of chronic versus episodic migraine also relates to comorbidities, with individuals with chronic migraine more likely to have a comorbidity, including depression and anxiety27; higher healthcare costs also correspond with the presence of a comorbidity.28 There is also mounting evidence that migraine is associated with increased risk of cardiovascular and cerebrovascular events, such as stroke and myocardial infarction.29,30

Impact of Emerging Therapies on Managed Care

Historic Review of the Last Major Change in Migraine Management: Introduction of Triptans

With the advent of CGRP-targeted biologics, migraine therapy appears to be poised for another revolutionary change. Such advances in treatment have not been seen in the 20 years since the last major evolution of migraine therapy occurred with the introduction of triptans, which were considered to be the most important breakthrough in 50 years.31,32 Triptans became a first-line therapy per evidence-based treatment guidelines based on their efficacy and safety.33,34 Several studies, many of which were sponsored by pharmaceutical companies, have analyzed the pharmacoeconomics of triptans as well as their effect on overall healthcare costs.35-39 Given different methodologies, efficacies, and outcomes, identifying a single best triptan is neither practical nor feasible. For example, the same research group found opposite effects of triptan use on healthcare costs based on differences in patient populations.37,38

 
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