For patients with migraines, it is more than just headache. The condition can be debilitating and impact patient quality of life considerably. Migraines can be completely incapacitating and may force patients to abandon day-to-day activities, including work and social commitments.
Within our current healthcare system, the burden of migraines for patients, and the comorbidities associated with the condition, result in substantial healthcare utilization. Real world evidence (RWE) can be used to inform decision-makers to identify the prevalence, patient characteristics, treatment patterns and associated costs of managing patients with migraine.
Migraine is a disabling neurovascular disorder characterized by pain and sensitivity to normal light, sound and movements. Additionally, auras, a common symptom of migraine, include visual, sensory, motor or verbal disturbances. Globally, headache disorders, including migraine, have been found to be the third leading cause of disability.
In Canada, estimates from the 2010-2011 Canadian Community Health Survey (CCHS) suggest that 8.3 percent of Canadians – or 2.7 million people – have been diagnosed with migraine. These numbers are considered to be underestimated as some people who experience migraines never seek professional help and thus a clinical diagnosis of migraine would not be reported in the CCHS.
According to the same CCHS estimates, the self-reported prevalence of migraine is higher in females (11.8%) than in males (4.7%), and highest in the 30-49 year-old age group (12.1%) compared with other age groups (0.7-9.9%).
In Canada, healthcare costs for patients with chronic and episodic migraine were recently evaluated in the International Burden of Migraine Study. Within the study they defined chronic migraine as: headaches occurring on 15 or more days per month, for more than three months, and having the features of a migraine headache on at least eight days per month. Episodic migraine was described as less than 15 headache days per month.
The total mean headache-related costs, including medical services and medications, were examined over a three-month period (2010). The study reported estimated costs were approximately three-times higher for patients with chronic migraine compared with those diagnosed with episodic migraines. The final report stated that annualized total costs were an average of $1883 per patient for chronic migraine compared with $687 per patient for episodic migraine.
There are two treatment strategies for migraine: control of acute attacks and prevention of future attacks. These treatment strategies are delivered through four lines of administration. First-line includes medications for acute migraine, such as: ibuprofen, acetylsalicylic acid (aspirin), naproxen sodium and acetaminophen. Second-line therapy, if needed, includes: triptans and antiemetics. Third-line treatment is typically naproxen sodium combined with a triptan and, if necessary, a fixed-dose analgesics with codeine are used as fourth-line therapy.
Furthermore, lifestyle modifications and preventative therapy are indicated in approximately one-third of patients and are cited as a central component of the overall management strategy to reduce migraine-related disability.
Despite the availability of preventative therapies (e.g. antiepileptics, beta-adrenergic antagonists, onabotulinumtoxinA), unmet needs exists for migraine treatment. There is a lack of information related to the safety and tolerability of medications, such as antiepileptics (valproate derivatives and topiramate), and beta-adrenergic antagonists.
In 2010, onabotulinumtoxinA (BOTOX®) was approved by the FDA for preventive treatment in patients with chronic migraine. Health Canada approval was obtained shortly thereafter in 2011. OnabotulinumtoxinA has demonstrated effectiveness in reducing frequency and severity of headaches in patients with chronic migraine. However, it has been associated with increased risk of adverse events, such as muscle weakness or pain around the face and neck, eyelid ptosis and the possibility of distant spread of onabotulinumtoxinA from the injection site. As a result, poor adherence to this treatment regimen has been noted. In contrast, the use of erenumab in preventative migraine treatment regimens has been associated with tolerable side effects, such as injection site reaction, nasopharyngitis and constipation.
Treatment adherence is particularly important to individuals diagnosed with chronic migraines, however due to the complex nature of medication, both acute and preventative, as well as lifestyle changes (e.g. regulation of diet, hydration, sleep, exercise and stress management), treatment adherence for chronic migraines are suboptimal. In fact, adherence rates for headache treatments range from 25-94% across various medicinal and behavioral therapies. In addition, both patients with episodic and chronic migraine tend to have multiple comorbidities, further complicating the issue of treatment adherence.
In terms of comorbidities, patients diagnosed with chronic migraine tend to be associated with more severe comorbidities related to psychiatric conditions of depression, anxiety, and bipolar disorders, as well as seizure disorders, hypertension, cerebrovascular disease, sleep disorders, and asthma. As a result, a substantial proportion of patients with migraine disorders take additional medications for these comorbid conditions, which can include: sedative hypnotics, antihypertensives, antidepressants, statins, antiplatelet agents, and laxatives. Therefore, medication regimens for migraine can be further complicated by polypharmacy, an increased risk of drug-drug interactions, and adverse effects. Evaluating the origins of suboptimal adherence to medication regimens, the presence of multiple comorbidities and related polypharmacotherapy is pertinent to reduce the burden of disease for patients with migraine.
As new antibody-based therapies such as erenumab become available, there is potential for increased treatment adherence with a monthly self-administered injection through the Amgen SureClick®. The self-administered erenumab, autoinjector does not require a loading dose and offers significant advantages, such as: reduced side effects, reduced dosing regimens and self-administration.
The burden of migraine, including various comorbidities, result in high rates of healthcare utilization and costs, predominantly in the form of emergency room visits. Identifying the real-world prevalence and characteristics of patients with migraine, current treatment patterns and associated healthcare utilization and costs may improve patient care and access to new treatments. As new therapies enter the market, RWE may inform prescribing patterns, improve adherence, and reduce healthcare costs.
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