Migraine and Payer Management Challenges

Headache is extremely common in the general population, but despite its high prevalence and impairment, migraine is often not recognized or effectively treated.¹ Because new classes of drugs and nondrug treatments continue to surface, more guidance and up-to-date resources are needed. 

Migraine is characterized by severe headache pain that can last several hours to several days, and is usually focused on one side of the head. Prior to a migraine, up to one-third of people will have visual, sensory, motor, or verbal disturbances that signal the beginning of a migraine. During an attack, a person will have sensitivity to light, and attacks may also consist of gastrointestinal, cognitive, and vestibular symptoms. After a migraine attack, a person may feel dizzy, tired, or have difficulty concentrating.²

Burden of Disease 

According to data from the Centers for Disease Control and Prevention, US Census Bureau, and the Arthritis Foundation, migraine is more common than asthma and diabetes combined, at 27.9 million individuals, and affects women three times more than men.³ 

Migraine is a debilitating condition that affects approximately 16% of adults and is the fifth leading cause of emergency department visits in the United States.⁴

On an individual basis, migraine can have a school, work, and social burden. A study published in 2001 found over half of people who suffered from migraine attacks said their work and school productivity was affected, 76% said they were unable to do household chores or housework, 67% reported their household work productivity had declined by at least half, and 59% missed family or leisure activities.⁵

The actual cost of migraine burden on the economy is significant. It is estimated that between 3.2 days and 89.2 days (average, 10.2 days) of school and work are lost each year from migraine attacks. One study looking at the effects of migraine in children found that 10.6% of children who suffer from migraine attacks miss an average of 4.1 school days per year. When children or adults who experience migraine attacks do attend school, presenteeism is a huge issue that impacts productivity.⁶

Treatment Options

The most common treatments for acute migraine include triptans, (5- hydroxytryptamine (5-HT) 1b/1d receptor agonists) which are available as pills, nasal sprays, and for injection under the skin.⁷ However, while safe and effective, triptans lose efficacy over time, may have intolerable side effects, or a patient has other health management challenges that conflict with their use.

“The need for new therapeutic options is highlighted by the persistent use of medications, such as barbiturates and opioids that have the potential for misuse, and recognition that frequent use of acute medications can lead to medication overuse headaches,” ICER explained in report. 

New therapeutic classes include calcitonin gene-related peptide (CGRP) antagonists and 5- hydroxytryptamine (5-HT) 1f agonists.

In addition, monoclonal antibodies targeting the CGRP receptor are being used for migraine prophylaxis. Two new oral CGRP receptor antagonists, referred to as gepants, ubrogepant (Ubrelvy, Allergan, FDA approved on December 23, 2019) and rimegepant (Biohaven, FDA approved February 27, 2020) have been studied for acute treatment of migraine attacks. A selective 5-HT 1f agonist or ditan, Lasmiditan (Reyvow, Lilly, FDA approved October 11, 2019), (also referred to as a “ditan”) is thought to work in a similar manner to the triptans. However, unlike the triptans, the gepants and lasmiditan do not have vasoconstrictive effects.⁷ (See Table 1).

Payer Coverage and Costs

Plans and providers are in need of education on the diagnosis and treatments for migraine and cluster headaches, according to AMCP. 

According to ICER, the incremental cost-effectiveness ratios for lasmiditan, rimegepant, and ubrogepant compared with usual care were $177,500, $39,800, and $40,000 per QALY gained, respectively. When compared with each other, rimegepant and ubrogepant dominated lasmiditan, being more effective and less costly.7

ICER explained in its report that it found that for patients for whom triptans are not effective, not tolerated, or are contraindicated, rimegepant and ubrogepant are cost effective. See redbook drug costs per dose in Table 2.

“The anticipated costs for novel migraine and cluster headache treatments and preventive medications may pose a burden for patients and payers in a disease states that has seen decades of high utilization of generic medications. However, there is some interest in exploring value-based and coverage with evidence generation arrangements,” AMCP explained in its Migraine Market Research Webinar. 

With new treatment options come new payer management challenges. The influx of new agents means the need for more data for formulary decision-making. AMCP said that many health plans do not have the ability to stratify patients within the migraine category—acute, prevention, cluster—which leads to challenges in coverage and potentially higher costs. 

There are few studies that effectively show the economic burden relieved by effective prevention of migraine so organizations like AMCP are coordinating efforts with stakeholders to provide payers with more resources and detailed guidelines to help differentiate between different treatment options. 

Another significant challenge faced is that payers may recognize the clinical distinction between cluster headaches and migraine but struggle to separate the management of the two.⁷ AMCP suggests to alleviate this burden, payers need improved education in patient type, provider diagnosis, clinical symptoms, and burden of disease. Challenges also present themselves when a patient needs to see a specialist but prior authorizations or lack of access prevent them from doing so, leading to higher costs and lower quality of life. 

Looking Ahead

As new classes of migraine treatment continue to roll through the pipeline, outcomes
of interest to payers are decreases in ER visits and hospitalizations, decreases in outpatient visits, and medication sparing effects for opioids and triptans. 

“Breakthroughs in non-drug migraine treatment options, which appear similarly effective to medication treatment options based on clinical trial data, will likely lead health plans to reconsider how they evaluate non-pharmaceutical treatments for coverage and formulary placement,” explained AMCP.  

References 

1. AMCP. Summit on the Future Treatments in Migraine and Cluster Headaches: Findings from the AMCP Market Insights Program [published online April 2020]. https://www.amcp.orghttps://s3.amazonaws.com/HMP/hmp_ln/imported/2020-04/MarketInsightMigraines_April2020.pdf. Accessed April 9, 2020. 
2. Ford JH, Ye W, Nichols RM, Foster SA, Nelson DR. Treatment patterns and predictors of costs among patients with migraine: evidence from the United States medical expenditure panel survey. J of Medical Econ. 2019. 22:(9),849-858. doi:10.1080/13696998.2019.1607358
3. Scher AI, Stewart WF, Liberman J, Lipton RB. Prevalence of frequent headache in a population sample. Headache. 1998;38(7):497-506. doi: 10.1046/j.1526-4610.1998.3807497.x 
4. Kangethe A, Polson M, Evangelatos TM, et al. Real-world assessment of concomitant opioid utilization and associated trends in patients with migraine. Am J Manag Care. 2020 Feb;26(1 Suppl):S8-S14. doi: 10.37765/ajmc.2020.42544.
5. Lipton RB, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001;41(7):646-657. doi: 10.1046/j.1526-4610.2001.041007646.x
6. Leonardi M, Raggi A. A narrative review on the burden of migraine: when the burden is the impact on people’s life. Headache.
7. Institute for Clinical and Economic Review. Acute treatments for migraine, final evidence report, February 25, 2020. https://icer-review.org/wp-content/uploads/2019/06/ICER_Acute-Migraine_Final-Evidence-Report_updated_030320.pdf. Accessed April 8, 2020.