A Framework for Estimating the Eligible Patient Population for New Migraine Acute Therapies in the United States

Abstract

Introduction: Migraine is associated with considerable disability for patients not adequately managed with current standards of care. New acute therapies may offer relief for this population of patients; however, population size and associated potential costs of new therapies are unclear. In this study, a conceptual framework was developed to estimate anticipated use of new acute therapies. Methods: Targeted literature review (TLR) was conducted to identify factors affecting access to migraine-specific acute therapies, and characteristics of individuals who would be eligible for new acute therapies. Findings from the TLR were combined to create a framework for estimating the size of the eligible patient population. This framework was used to calculate two estimates of the eligible patient population by applying parameters (i) identified in the TLR and (ii) from a recent budget-impact analysis (BIA). Results: The primary factors affecting access to migraine-specific acute therapies identified in the TLR were consulting a healthcare professional for headache, receiving a migraine diagnosis, and receiving a prescription for migrainespecific treatment. Characteristics of individuals likely to use new acute therapies reflected in the TLR were contraindication to triptans, or failure to respond to/tolerate at least two oral triptans. Application of the framework suggested that 15-25% of individuals with migraine would be eligible for new acute therapies. Conclusion: A limited number of patients currently use migraine-specific acute therapies. Among such patients, a significant proportion do not have adequate symptom control. Accordingly, a minority of individuals with migraine may be expected to use new acute therapies. The framework developed in this study is intended to facilitate estimating the eligible patient population in assessments of costs of new acute therapies. Such assessments should also consider recommendations that patients have access to multiple types of acute therapies, which may yield savings from reduced medication-overuse headache (MOH),

Observational Analysis of the Costs Associated with Acute Treatment of Breakthrough Migraine Attacks in Medicaid Patients Using Preventive Therapies

“…This analysis of prescription data for Medicaid enrollees with FFS coverage in 2020 showed that approximately 20% of migraine-specific acute therapy prescriptions were for formulations other than generic triptan tablets. This estimate is consistent with previous research in the USA [37] and England [38] as well as with a US budget impact analysis of new acute therapies May require an extra dose or rescue medication [44][45][46][47] b 1 unit per 24 h [48] c 1 unit per month [49][50][51] d 1 unit (30-min infusion) per 3 months [52] Adv Ther [39] conducted in 2019 by the Institute for Clinical and Economic Review, suggesting that 15-25% of patients with migraine may progress beyond first-line migraine-specific acute treatments. Per-unit cost estimates based on Medicaid amounts reimbursed indicated that, among migraine-specific acute therapies, intranasal DHE is the most expensive followed by injectable DHE, injectable triptans, gepants (rimegepant, ubrogepant) and lasmiditan, intranasal triptans, other oral ergotamine-based therapies, and oral triptans.…”

Toll-like receptors and their role in neuropathic pain and migraine

“…It can be relieved after rest and aggravated after activity. If treated inactively or improperly, headache severity may progress throughout an attack and even develop into chronic migraine [ 1 ].…”

“…Migraine is divided into episodic (< 15 monthly headache days, MHDs) and chronic (≥ 15 MHDs, with migraine attacks occurring at least 8 days per month), according to the frequency of headache days per month [ 2 ]. In the 2016 Global Burden of Disease Study, migraine was a leading cause of disability among patients under 50 years of age worldwide, second only to lower back pain [ 1 , 3 ].…”

Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm

“…These therapies are currently recommended for use in adult patients with insufficient response to 2 or more triptans, or for those who experience intolerable side effects or have contraindications to triptans 5. A targeted literature review found that 15% to 25% of patients with migraine fulfill these requirements and may be eligible for rimegepant, ubrogepant or lasmiditan 7…”

“…5 A targeted literature review found that 15% to 25% of patients with migraine fulfill these requirements and may be eligible for rimegepant, ubrogepant or lasmiditan. 7 These CGRP receptor antagonists reduce pain and inflammation and have fewer adverse events than older treatments due to their mechanism of action, [8][9][10] and they have no apparent association with medication overuse headache. 5 Ubrogepant is currently approved by the US Food and Drug Administration (FDA) for the acute treatment of migraine in adults, and rimegepant is a dual-use therapy approved for both acute and preventive treatment.…”