Migraine is a progressive headache disorder affecting approximately 14.0% of the world population. Women are more affected than men, with the greatest prevalence in women age 15 to 49 years, and migraine is one of the most common causes of disability in women. 1-3 Episodic migraine progresses to daily chronic migraine (CM) in 3%-5% of individuals.4-6 CM is defined as a headache occurring ≥15 days per month for at least 3 months.7 CM is one of the most burdensome neurological diseases in the United States. CM has been found to have a significant impact on disability-specific quality of life measures, and increased direct and indirect costs.6,8-11 Of those suffering from CM, 33% use preventive medications.12 However, there is a shortage of effective and tolerable preventive treatments for chronic migraine.
Guidelines from the American Academy of Neurology (AAN) from 2012 recommend a number of drug classes for migraine prevention in adults, largely oral migraine preventive medications (OMPM). However, in studies of patients taking OMPM, the majority discontinued their first, second, and third OMPM.10,13,14 Preventive medications that are long-acting and injectable, rather than oral, include calcitonin gene-related peptide (CGRP) antagonists and onabotulinumtoxinA A (ona-BoNTA). Ona-BoNTA has been given a level A recommendation for migraine prophylaxis by the AAN.15 There are not yet AAN guidelines that include CGRP antagonists; however, these drugs are quickly becoming competitive with ona-BoNTA in clinical practice as second-line medications for migraine prevention.16-20
The US Food and Drug Administration (FDA) first approved ona-BoNTA for clinical use in 1989, for the indications of strabismus, blepharospasm, and hemifacial spasm.21 Ona-BoNTA was approved in 2010 for use in the treatment of CM,20 22 based on results from two clinical trials, the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) 1, and PREEMPT 2.23,24 Pooled analysis of these trials showed a significant reduction in the number of headache days per month and the number of moderate or severe headache days per month after 24 weeks of treatment.25 Further subgroup analysis found that patients treated with ona-BoNTA experienced significant improvements in quality of life. Subsequently, additional studies have demonstrated the safe and effective use of ona-BoNTA as a second-line agent with high adherence for CM prevention,16,26 and real-world studies have published findings consistent with the PREEMPT studies. 27-32 CGRP antagonists, such as erenumab, are medications injected monthly or as infrequently as quarterly, and have also demonstrated efficacy in prevention of CM.33 However, CGRP antagonists are more costly than ona-BoNTA injections.16
CM has a greater toll on patients and the health care system than other forms of migraine.6,34 However, there are few studies that have examined the cost-effectiveness of ona-BoNTA compared to CGRP antagonists.35 Erenumab, a CGRP antagonist, and ona-BoNTA are both recommended as second-line agents in preventive treatment for chronic migraine.16 Both Ona-BoNTA and CGRP antagonists have demonstrated significant reductions in CM– related costs.35,36 The aim of this study is to compare the cost-effectiveness of treatment with ona-BoNTA versus erenumab from the perspective of a large US third-party payer.
References
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