Real-life use of onabotulinumtoxinA reduces healthcare resource utilization in individuals with chronic migraine: the REPOSE study

Abstract

Background: Chronic migraine (CM) is associated with substantial economic burden. Real-world data suggests that onabotulinumtoxinA treatment for CM reduces healthcare resource utilisation (HRU) and related costs.

Methods: REPOSE was a 2-year prospective, multicentre, non-interventional, observational study to describe the real-world use of onabotulinumtoxinA in adult patients with CM. This analysis examined the impact of onabotulinumtoxinA on HRU. Patients received onabotulinumtoxinA treatment approximately every 12 weeks according to their physicians' discretion, guided by the summary of product characteristics (SPC) and PREEMPT injection paradigm. HRU outcome measures were collected at baseline and all administration visits and included headache-related hospitalizations and healthcare professional (HCP) visits. Health economic data, including family doctor and specialist visits, inpatient treatment for headache, acupuncture, technical diagnostics, use of nonpharmacologic remedies, and work productivity were also collected for patients enrolled at German study centres.

Results: Overall, 641 patients were enrolled at 78 study centres across 7 countries (Germany, UK, Italy, Spain, Norway, Sweden, and Russia), 633 received ≥1 onabotulinumtoxinA dose, and 128 completed the 2-year study. Patients were, on average, aged 45 years, 85% were female, and 60% (n = 377) were from Germany. At the end of the 2-year observation period, significantly fewer patients reported headache-related hospitalizations (p < 0.02) and HCP visits (p < 0.001) within the past 3 months than in the 3 months before baseline. In the German population, reductions were observed across all health services at all follow-up visits compared with baseline. The percentage of patients who saw a family doctor decreased from 41.7% at baseline to 13.5% at administration visit 8 and visits to a medical specialist decreased from 61.7% to 5.2% of patients. Inpatient acute treatment and technical diagnostics declined from 6.4% and 19.7% of patients at baseline to 0.0% and 1.0% at administration 8, respectively. The use of nonpharmacologic remedies and medication for the acute treatment of migraine also decreased with continued onabotulinumtoxinA treatment. Work incapacity, disability, absenteeism, and impaired performance at school/work improved with onabotulinumtoxinA treatment for CM over the 2-year observation period.

Conclusions: Real-world evidence from REPOSE demonstrates that onabotulinumtoxinA treatment is associated with decreased HRU and supports the long-term benefits associated with the use of onabotulinumtoxinA for CM in clinical practice.

Trial registration: NCT01686581 . Name of registry: ClinicalTrials.gov. URL of registry: Date of retrospective registration: September 18, 2012. Date of enrolment of first patient: July 23, 2012.

Keywords: Burden; Chronic migraine; Economic; Headache; Healthcare; Healthcare resource utilization; OnabotulinumtoxinA.

Fig. 1

a Mean (SD) change from baseline in frequency of headache days. The patient-reported estimate of the number of days in a month with a headache (≥4 h) at each administration visit through visit 8; b Mean (SD) change from baseline in total MSQ score; c Mean (SD) change from baseline in EQ-5D total score. *P < 0.001 Wilcoxon signed rank test for change versus baseline (level of significance, 5%). Abbreviations: Admin, administration; MSQ = Migraine-Specific Quality-of-Life Questionnaire, EQ-5D = EuroQol 5-Dimension Questionnaire

Fig. 2

a Percentage of patients who reported a headache-related hospitalization in the 3 months prior to baseline or since the last onabotulinumtoxinA administration for follow-up visits; b Percentage of patients who visited any HCP in the 3 months prior to baseline or since the last onabotulinumtoxinA administration for follow-up visits. The number of patients in administration (Admin) visits for the overall and German populations are as follows: Admin 1, n = 633 overall, n = 377 Germany; Admin 3, n = 485 overall, n = 270 Germany; Admin 5, n = 371 overall, n = 210 Germany; Admin 8, n = 200 overall, n = 123 Germany. *P < 0.02, **P < 0.0001 McNemar test for difference versus baseline (level of significance, 5%). Abbreviations: Admin, administration; HCP, healthcare professional

Fig. 3

Health economic questionnaire data from German patients in the SAF enrolled before 08 April 2014 showing percentages of patients who visited a family doctor (●), visited a medical specialist (■), and used remedies, including massage, manual therapy, and physiotherapy (▲). Percentages are related to the number of patients at the respective visit. The reporting window for the baseline visit was the last 6 months; follow-up since the last visit. Non-overlapping 95% confidence intervals (CIs) at each time point vs. baseline are denoted by * for visits to a family doctor, # for visits to a medical specialist, and ‡ for use of remedies; non-overlapping 95% Cis show statistical significance

Fig. 4

Health economic questionnaire data from German patients in the SAF enrolled before 08 April 2014. Percentage of patients who had been incapacitated for work (●) or reported a disability (■) in the last 6 months prior to baseline or since the last visit, and the percentage of patients that had been absent from school or work (▲) or stated that performance at school or work had been impaired when having a headache at school/work (♦) in the last 4 weeks prior to baseline or since the last visit. Percentages are related to the number of patients at the respective visit. Non-overlapping 95% confidence intervals at each time point vs. baseline are denoted by * for absenteeism, # for work incapacity, and ‡ for impaired performance; non-overlapping 95% Cis show statistical significance