Evaluating Migraine Advancements Through a Payer's Perspective

Panelists YuQian Liu, PharmD, and Carly Rodriguez, PharmD, FAMCP, from the session “Evaluating Migraine Advancements through Payer Eyes,” discussed migraine treatment advances, available real-world evidence, and migraine management strategies with moderator Charles Collins, MS, MBA, at AMCP Nexus 2019.

Migraine is a neurological disorder caused by noxious stimuli presumed to activate the trigeminal nerve system and release calcitonin gene-related peptide (CGRP). For nearly 37 million affected individuals in the United States, migraines cause debilitating neurological symptoms such as disabling pain, visual disturbances, and severe throbbing of the head, with a chief link to women between the ages of 25 and 55.

Migraine treatment often falls under 2 categories, acute and preventive. Acute treatment aims to provide rapid and consistent relief from migraine-related pain and symptoms, while preventive treatment seeks to reduce the frequency, severity, and duration of migraine or headache episodes. These treatments assist people experiencing either episodic migraines (≥5 lifetime attacks; ≤14 headache days per month) or chronic migraines (≥15 migraine-like or tension-like headache days per month for >3 months; ≥8 migraine days per month for >3 months) by managing frequency and inhibiting the release of CGRP.

In discussing current treatments for these 2 subsets of migraines, Liu listed triptans, ergotamine derivatives, nonsteroidal anti-inflammatory drugs, opioids (not recommended), and combination medication (sumatriptan/naproxen) as treatment options for acute migraines, and additionally listed antiepileptic drugs, β-blockers, triptans, and antidepressants as preventative treatments. Emerging innovations beyond phase 3 trials in these 2 treatment areas were provided by Rodriguez along with anticipated approval dates:

• Emerging acute treatment drugs for migraine: ubrogepant (oral CGRP inhibitor; anticipated approval: December 2019), rimegepant (oral CGRP inhibitor; anticipated approval: fourth quarter 2019), lasmiditan (oral centrally-acting serotonin agonist; anticipated approval: fourth quarter 2019)
• Emerging preventive treatment drugs for CM: eptinezumab (IV CGRP inhibitor; anticipated approval: February 2020)

Real-world evidence (RWE) has served as a chief indicator when evaluating a variety of these clinical studies, as advantages such as large sample sizes, practical use, and capturing the patient experience have provided invaluable data to illuminate potentially unmet needs. However, the disadvantages of RWE, involving applicability, confounders, data integrity, and reporting bias, can serve as potential limitations to the efficacy of the data, noted Rodriguez.

Utilizing value-assessment systems such as analyses from the Institute for Clinical and Economic Review (ICER) can assist in managing these emerging treatments by determining clinical efficacy and economic impact. RWE assists in providing ample evidence of current trends in healthcare, and although it portrays valuable information for migraine care, such as that adding additional acute treatments does not decrease heachache-related disability or resource utilization, it was the ICER analyses that suggested the cost of CGRP inhibitors may not be justified by clinical effect. Accounting for these 2 systems that target areas of clinical effectiveness can benefit payers through heightened reference data.

In summarizing formulary and utilization management strategies for acute and preventive treatment, Rodriguez spoke of 6 key steps needed for effective implementation:

• Conservative therapies first
• Encourage generics
• Verify appropriate utilization through prior authorization
• Evaluate combination use
• Manage experimental and investigational use
• Identify preferred products when possible