Real-world Impact of Fremanezumab on Migraine-Related Health Care Resource Utilization in Patients with Comorbidities, Acute Medication Overuse, and/or Unsatisfactory Prior Migraine Preventive Response

Abstract

Introduction: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is indicated for preventive treatment of migraine in adults. Real-world evidence assessing the effect of fremanezumab on migraine-related medication use, health care resource utilization (HCRU), and costs in patient populations with comorbidities, acute medication overuse (AMO), and/or unsatisfactory prior migraine preventive response (UPMPR) is needed.

Methods: Data for this US, retrospective claims analysis were obtained from the Merative^® MarketScan^® Commercial and supplemental databases. Eligible adults with migraine initiated fremanezumab between 1 September 2018 and 30 June 2019 (date of earliest fremanezumab claim is the index date), had ≥ 12 months of continuous enrollment prior to initiation (preindex period) and ≥ 6 months of data following initiation (postindex period; variable follow-up after 6 months), and had certain preindex migraine comorbidities (depression, anxiety, and cardiovascular disease), potential AMO, or UPMPR. Changes in migraine-related concomitant acute and preventive medication use, HCRU, and costs were assessed pre- versus postindex.

Results: In total, 3193 patients met the eligibility criteria. From pre- to postindex, mean (SD) per patient per month (PPPM) number of migraine-related acute medication and preventive medication claims (excluding fremanezumab), respectively, decreased from 0.97 (0.90) to 0.86 (0.87) (P < 0.001) and 0.94 (0.74) to 0.81 (0.75) (P < 0.001). Migraine-related outpatient and neurologist office visits, emergency department visits, and other outpatient services PPPM decreased pre- versus postindex (P < 0.001 for all), resulting in a reduction in mean (SD) total health care costs PPPM from US$541 (US$858) to US$490 (US$974) (P = 0.003). Patients showed high adherence and persistence rates, with mean (SD) proportion of days covered of 0.71 (0.29), medication possession ratio of 0.74 (0.31), and persistence duration of 160.3 (33.2) days 6 months postindex.

Conclusions: Patients with certain migraine comorbidities, potential AMO, and/or UPMPR in a real-world setting had reduced migraine-related medication use, HCRU, and costs following initiation of fremanezumab. Graphical abstract available for this article.

Keywords: Acute medication overuse; Adherence; CGRP; Costs; Fremanezumab; HCRU; Migraine; Real-world evidence.

Fig. 1

Study design. ^aPatients are followed until disenrollment or end of study period; per patient per month analysis conducted to account for variable follow-up. ^bFirst fremanezumab initiation defined as the date of first pharmacy claim for fremanezumab

Fig. 2

Patient attrition diagram. AMO acute medication overuse, UPMPR unsatisfactory prior migraine preventive response, CGRP calcitonin gene-related peptide, MDD major depressive disorder, GAD generalized anxiety disorder, CVD cardiovascular disease, ICD-10, International Classification of Diseases, 10th revision, NSAID nonsteroidal anti-inflammatory drug. ^aSelected comorbidities included MDD, GAD, or CVD and were defined by greater than or equal to one inpatient or greater than or equal to two outpatient medical claims (≥ 30 days apart) with an ICD-10 diagnosis code for MDD, GAD, or CVD during the 12-month preindex period. AMO was defined as ≥ 15 pills per month of paracetamol, NSAIDs, or acetylsalicylic acid; ≥ 10 pills per month of ergots, triptans, nonopioid combination analgesics, or opioids; or ≥ 10 pills per month of any combination of these acute medications. Patients were classified as having an UPMPR if they had claims greater than or equal to two of migraine preventive medication classes during the 12-months preindex

Fig. 3

Adherence with fremanezumab over 6 months and 12 months based on A mean MPR, B mean PDC, and C proportion of MPR and PDC ≥ 0.80. MPR medication possession ratio, PDC proportion of days covered, MDD major depressive disorder, GAD generalized anxiety disorder, AMO acute medication overuse

Fig. 4

Proportion of patients using individual A acute medications^a and B preventive medications^b in the overall population and subgroups. NSAID nonsteroidal anti-inflammatory drug, MDD major depressive disorder, GAD generalized anxiety disorder, AMO acute medication overuse. ^a < 6% of patients were using the following acute medications preindex: ergots, paracetamol, and nonopioid combination analgesics. ^b < 5% of patients were using antihistamines preindex. ^cIncluding acetylsalicylic acid. ^dIncluding combinations; preindex versus postindex: strong opioids: overall population, 42.7% versus 37.5% (P = 0.001), AMO subgroup, 55.8% versus 50.6% (P = 0.054), prior erenumab exposure subgroup, 43.6% versus 38.4% (P = 0.237); weak opioids: overall population, 27.8% versus 23.4% (P < 0.001), AMO subgroup, 38.6% versus 30.7% (P < 0.001), prior erenumab exposure subgroup, 23.7% versus 23.7% (P = 1.000). ^eAntiepileptics and anticonvulsants. ^fAntihypertensives, antianginals, antiarrhythmics, and alpha agonists

Fig. 5

Migraine-related HCRU PPPM for A overall patients and those with B MDD and/or GAD, C potential AMO, or D prior erenumab use. HCRU health care resource utilization, PPPM per patient per month, MDD major depressive disorder, GAD generalized anxiety disorder, AMO acute medication overuse

Fig. 6

Migraine-related A acute and B preventive^a medication costs PPPM in overall patients, and those with MDD and/or GAD, potential AMO, or prior erenumab use. PPPM per patient per month, USD US dollars, MDD major depressive disorder, GAD generalized anxiety disorder, AMO acute medication overuse. ^aPreventive medication costs excluding fremanezumab

Fig. 7

Total migraine-related health care costs (excluding fremanezumab), PPPM. PPPM per patient per month, USD US dollars, MDD major depressive disorder, GAD generalized anxiety disorder, AMO acute medication overuse