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REPORT
Burden of Migraine and Impact
of Emerging Therapies on Managed Care
Sheldon J. Rich, PhD, RPh
Burden of Migraine
ABSTRACT
Individual and Societal Burden
The burden of migraine takes many forms and, by several measures, Migraine is a highly prevalent neurological condition with substantial
makes a substantial global impact by causing considerable disability. impact on individuals through associated complications, comorbidities,
Estimates on the annual direct costs of migraine in the United States and increased healthcare costs. The burden on society is likewise
substantial via increased healthcare costs and greater indirect costs, such
range from $9 billion to $28 billion.1-3 The ranking of migraine in
as lost productivity. Research about the pathophysiology of migraine has
the Global Burden of Disease (GBD) survey in terms of years lived
led to the introduction of a new class of drugs, calcitonin gene-related
with disability (YLDs) has increased steadily from 19th in 2000 to peptide (CGRP) inhibitors. Current drugs in this class are biologics,
sixth in 2013 and to second in 2016.4-6 When focusing on disability- which are often accompanied by high prices. A highly competitive and
adjusted life-years (DALYs) in people between the ages of 15 years rapidly evolving market landscape is being shaped by biopharmaceutical
and 49 years, migraine ranked as the third cause of disability in manufacturers and managed care payers. With an understanding of the
societal impact of migraine and the potential impact of CGRP biologics,
2015 and first in 2016. The increase in global YLD ranking may be
5,7
healthcare providers and managed care professionals should be prepared
a result of better and more comprehensive data collection rather
to develop policies and procedures to ensure appropriate patient access
than an increase in prevalence5; however, with improvements in to new therapies.
data, the impact of migraine becomes more apparent. In 2016 alone,
an estimated 1.04 billion people worldwide experienced migraine Am J Manag Care. 2019;25:S35-S39
For author information and disclosures, see end of text.
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 preva-
lence 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
THE AMERICAN JOURNAL OF MANAGED CARE® Supplement VOL. 25, NO. 2 S35REPORT
Direct and Indirect Costs $5.4 billion to diminished productivity.16 In a survey study, respon-
As expected with a condition of such extensive prevalence, direct dents indicated that 64% of migraines occurred during weekdays
and indirect costs of migraine are substantial. In recently published and, of those weekday migraines, 68% interfered with work produc-
papers, total direct annual costs per patient were estimated to be tivity in absenteeism, presenteeism, or both. Study results also
between $11,0101 and $13,032,12 and both estimates were signifi- suggest that presenteeism accounted for more work-hours lost
cantly greater than controls without migraine by $65751 to $9798.12 (1470 work-hour equivalents) compared with absenteeism (1169
Bonafede et al compared their results to previously published data work-hours).17 Individuals with migraine may miss an additional
that used similar methods. Adjusting for inflation, Bonafede et al 4 to 8 workdays per year, but appropriate treatment may reduce
estimated a $6575 incremental direct cost due to migraine, which the losses in worker productivity.16,18 The relative contribution of
was 1.82 times greater than the previous estimate of $3609 by presenteeism versus absenteeism may be an important factor in
Hawkins et al. With the higher estimated direct costs, Bonafede
1
addressing certain impacts of migraine, but the overall magnitude
et al estimated the annual direct costs of migraine in the United of indirect costs may be more important to consider.
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 Personal Life Impact
$11.07 billion.2 Direct costs may also be affected by chronic versus Per the GBD, migraine ranked second in YLDs in 20166 and contrib-
episodic migraine status. Patients with chronic migraine may uted to 45.1 million YLDs.6,8 With that magnitude of disability, the
incur $3238 more in annual direct costs compared with patients impact on the lives of individuals can be difficult to overestimate.
with episodic migraine,13 suggesting that individuals who experi- Health-related quality-of-life (HRQOL) surveys, including headache-
ence chronic migraine drive the bulk of migraine costs. Although or migraine-specific tools (eg, the Migraine-Specific Quality of Life
the estimates may vary, the impact of multibillion–dollar annual Questionnaire Version 2.1 [MSQ]),19 serve to help frame the effect of
direct healthcare costs is staggering. migraine on individuals. Individuals with migraine scored lower
The indirect costs of migraine are also substantial, with annual on HRQOL surveys compared with the control participants,20 and
estimates similarly in the billions of dollars. Hawkins et al acknowl- patients with chronic migraine tended to score lower on HRQOL
edged that their estimate of annual indirect cost of $12 billion parameters compared with patients with episodic migraine.21,22
is likely an underestimate primarily because presenteeism was Researchers are also becoming interested in the impact of the condi-
excluded in their analysis.14 Annual indirect costs on a per-patient tion on family members of individuals with migraine23 as well as
basis were similarly greater in the migraine cohorts versus controls the effect of treatment modalities on HRQOL.24,25
by $2350, with $11,294 in indirect costs for patients with migraine Employment issues may also be considered a component of
compared with $8945 in indirect costs for control patients.1 The the personal life impact due to migraine. In their study of direct
patient’s status of chronic or episodic migraine also contributes to and indirect costs, Messali et al observed that a lower percentage
differences in indirect costs. A study by Munakata et al estimated of individuals with chronic migraine are employed (full- or part-
that the costs of lost productivity per person per year was $5392 for time) compared with patients with episodic migraine (49.5% for
patients with chronic migraine compared with $978 for patients chronic vs 60.5% for episodic).13 The authors acknowledge that the
with episodic migraine for an incremental cost of $4414.15 On the opportunity cost of unemployment is not adequately captured in
other hand, Messali et al reported a more modest difference, with indirect cost analysis and they suggest that this opportunity cost
$2357 in incremental annual indirect costs for patients with chronic may be substantial.13 Considering the role of work life in modern
migraine ($3300) compared with patients with episodic migraine society, the opportunity cost may extend beyond economic costs
($943).13 Overall, Messali et al determined that total, direct, and to impact an individual’s personal life. Whether employment costs,
indirect costs were all significantly greater in chronic migraine healthcare costs, quality of life, or comorbidities, the effects of
compared with episodic migraine.13 migraine on an individual’s life can be substantial, and healthcare
providers should be mindful of the myriad ways that migraine
Work Productivity: Absenteeism and Presenteeism impacts patients.
Loss of work productivity in the forms of absenteeism and presen-
teeism (working while sick/impaired) represents the indirect costs Comorbidities
of an illness. As described previously, indirect costs due to migraine In addition to QOL issues, a number of comorbidities can accom-
are upwards of $12 billion, excluding presenteeism concerns.14 pany migraine. Psychiatric conditions that often occur along
Presenteeism, however, can contribute substantially to indirect with migraine include depression, anxiety disorder, and bipolar
costs of migraine. Another annual estimated indirect cost (in 1999 disorder.22,26,27 Other comorbidities include fibromyalgia, restless
USD) of $13.3 billion attributed $7.9 billion to absenteeism and legs syndrome, and epilepsy, among others.26 The issue of chronic
S36 JANUARY 2019 www.ajmc.comBURDEN OF MIGRAINE AND IMPACT OF EMERGING THERAPIES ON MANAGED CARE
versus episodic migraine also relates to comorbidities, with indi- Implication of Emerging Therapies on
viduals with chronic migraine more likely to have a comorbidity, Migraine Treatment
including depression and anxiety27; higher healthcare costs also When new drug therapies are introduced for a condition or disease,
correspond with the presence of a comorbidity.28 There is also 2 concerns remain paramount: (1) the efficacy/safety in a particular
mounting evidence that migraine is associated with increased risk patient population and (2) the costs of the new drugs. Although the
of cardiovascular and cerebrovascular events, such as stroke and efficacy and safety parameters are evaluated by the FDA before drug
myocardial infarction.29,30 approval, real-world efficacy and safety data will emerge as a broader
population uses the new drug. The cost of the drug, whether to the
Impact of Emerging Therapies on Managed Care patient, insurer, or payer, can become a complicated matter. Before
Historic Review of the Last Major Change in the introduction of CGRP inhibitors and 5-HT1F agents in migraine
Migraine Management: Introduction of Triptans therapy, managed care professionals incorporated triptans and
With the advent of CGRP-targeted biologics, migraine therapy appears onabotulinum toxin onto formularies to various extents, typically
to be poised for another revolutionary change. Such advances in with step-therapy procedures, prior authorization requirements,
treatment have not been seen in the 20 years since the last major and/or monthly quantity limits.40 Similar approaches would be
evolution of migraine therapy occurred with the introduction of expected for emerging migraine therapies. As injectable biologics,
triptans, which were considered to be the most important break- the current CGRP inhibitors are expected to come with higher costs
through in 50 years.31,32 Triptans became a first-line therapy per and different administration concerns. Therefore, to evaluate the
evidence-based treatment guidelines based on their efficacy and potential impact of the costs of CGRP inhibitors on managed care
safety.33,34 Several studies, many of which were sponsored by phar- decision making, the historical examples of hepatitis C drugs and
maceutical companies, have analyzed the pharmacoeconomics of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
triptans as well as their effect on overall healthcare costs.35-39 Given as well as the current pricing and marketing strategies employed
different methodologies, efficacies, and outcomes, identifying a for CGRP inhibitors will be reviewed.
single best triptan is neither practical nor feasible. For example,
the same research group found opposite effects of triptan use on Presentation of an Analogue Case (Similar Number
healthcare costs based on differences in patient populations.37,38 of Patients Affected, Similar Costs) to Demonstrate
Availability of generic versions of triptans subsequent to the Potential Impact of a New Biologic
analyses may also impact economic conclusions.35,39 Variability As managed care professionals and clinicians prepare for new
in costs and patient response to triptans may warrant the inclu- migraine drugs, 2 previous examples of costly, novel drugs may
sion of multiple triptans in formularies.39 Payers have managed provide perspective. In the first instance, the introduction of anti-
costs associated with triptan therapy through common methods, viral drugs for hepatitis C created extraordinary financial pressures
such as step therapy, by potentially requiring other therapies on the US healthcare system. Focusing on Medicare Part D, spending
(eg, nonsteroidal anti-inflammatory drugs or preventive rather on hepatitis C drugs increased more than 15-fold from $283 million
than abortive treatments) as a prerequisite before triptan use and in 2013 to $4.5 billion in 2014.43,44 The out-of-pocket spending for a
monthly quantity limits. Payers have also included triptans with Medicare Part D patient with hepatitis C (without a subsidy) ranged
different dosage forms (injectable, oral, nasal) in formularies. As a from $6297 to $10,889 for a course of treatment.43 Such large drug
result, insurance coverage, access barriers to triptans, and quantity costs are becoming increasingly common and cost shifting to
limits vary widely across both government and private insurance higher co-payments and deductibles has become commonplace.45
plans.40 In addition, access to triptans may be affected by socio- The PCSK9 inhibitors represent a new class of monoclonal anti-
economic status either alone or as a result of the type and extent body drugs for hyperlipidemia.46 Patients hoping to obtain access to
of health insurance coverage. 38,41
Although triptans are effective PCSK9 inhibitors have encountered hurdles of more cumbersome
both therapeutically and economically, the drugs are not appro- prior authorization requirements and high prior authorization
priate for a substantial portion of the population with migraine rejection rates.47,48 Because the drugs’ high price tags may have
due to cardiovascular complications and contraindications 42; negatively affected market growth, pharmaceutical companies
thus, the role of new therapies in managed care may be impacted. marketing one of the PCSK9 inhibitors, alirocumab, struck a deal
The experience with triptans provides context for managed care in 2018 with a major pharmacy benefit manager to lower the price
approaches to new migraine therapies, and pharmacoeconomic via rebates.49 In response to lagging sales apparently due to the high
and health economic studies with the new drugs will be needed to costs and lack of payer coverage, the manufacturer of evolocumab
help determine the best approach to provide quality medical care decreased the list price of that drug in October 2018 by approximately
to individuals with migraine. 60% from over $14,000 annually to $5850 annually.50 The price and
THE AMERICAN JOURNAL OF MANAGED CARE® Supplement VOL. 25, NO. 2 S37REPORT
patient access issues for new migraine drugs may not mirror those Biopharmaceutical manufacturers are competing for market share
of hepatitis C drugs or PCSK9 inhibitors, but these examples serve and inclusion in payer formularies through a variety of approaches.
to illustrate the impact of drug cost, appropriate utilization, and As demand for CGRP inhibitors increases, managed care profes-
the role of payers in managing costs and access. sionals may anticipate a range of payer mechanisms that will
ideally balance patient access concerns with budgetary issues. n
Forward-looking Strategic Planning Using Analogue
Author affiliation: President, SJR Associates, LLC; and Adjunct Clinical
Biologics and Historic Data Assistant Professor, University of Michigan, Ann Arbor, MI.
The prevalence of migraine contributes to the heightened interest Funding source: This activity is supported by educational funding
in finding novel and effective therapies for preventing and treating provided by Teva Pharmaceuticals.
the condition. As new migraine treatments become commercially Author disclosure: Dr. Rich has no relevant financial relationships with
commercial interests to disclose.
available, the big questions of cost and access come to the forefront. Authorship information: Concept and design; drafting of the manuscript;
A complex interplay among manufacturers, payers, pharmacy benefit and critical revision of the manuscript for important intellectual content.
managers, clinicians, and patients creates an atmosphere of uncer- Address correspondence to: SJRAssociates@aol.com.
tainty regarding the availability of new migraine drugs. Managed Medical writing and editorial support provided by: Thomas J. Cook, PhD, RPh.
care professionals can apply historical experience with hepatitis
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