Abstract
BackgroundOnabotulinumtoxinA (BOTOX®, Allergan plc, Dublin, Ireland) is approved for the preventive treatment of headaches in adult patients with chronic migraine (CM) in Australia by the country’s reimbursement mechanism for medicines, the Pharmaceutical Benefits Scheme (PBS). To our knowledge, this study represents the first focused report evaluating real-world evidence of onabotulinumtoxinA treatment via the PBS in Australian clinics.MethodsThis study reviewed the medical records of adults with inadequately controlled CM from 7 private neurology practices in Australia who, beginning in March 2014, received PBS-subsidized onabotulinumtoxinA per product labelling for the first time. The primary effectiveness measure was the percentage of patients achieving a response defined by 50% or greater reduction in headache days from baseline after 2 treatment cycles. Additional data were recorded in the case report form when available and included demographics, clinical characteristics, headache severity and frequency, Headache Impact Test (HIT-6) score, medication use, and days missed of work or study at baseline, after 2 treatment cycles, and at last follow-up. Differences in mean changes from baseline were evaluated with a 1-tailed t-test or Pearson’s chi-squared test (p < 0.05).ResultsThe study population included 211 patients with a mean (SD) of 25.2 (5.3) monthly headache days at baseline. In the primary outcome analysis, 74% of patients achieved a response, with a mean (SD) of 10.6 (7.9) headache days after 2 treatment cycles (p < 0.001). Secondary effectiveness outcomes included mean (SD) reductions in HIT-6 score of − 11.7 (9.8) and − 11.8 (12.2) after 2 treatment cycles (p < 0.001) and final follow-up (p < 0.001), respectively, and mean (SD) decreases in days per month of acute pain medication use of − 11.5 (7.6) after 2 treatment cycles (p < 0.001) and − 12.7 (8.1) at final follow-up (p < 0.001).ConclusionThis study provides additional clinical evidence for the consistent effectiveness of onabotulinumtoxinA for the treatment of CM in Australia. This effectiveness was made evident by reductions in migraine days, severe headache days, and HIT-6 scores from baseline.
Highlights
OnabotulinumtoxinA (BOTOX®, Allergan plc, Dublin, Ireland) is approved for the preventive treatment of headaches in adult patients with chronic migraine (CM) in Australia by the country’s reimbursement mechanism for medicines, the Pharmaceutical Benefits Scheme (PBS)
Patients Of the 236 medical records reviewed between April 2016 and January 2017, 25 records were excluded for the following reasons: the patient was not covered by the PBS (n = 17), the patient did not receive a second treatment cycle or was not assessed after the second cycle (n = 4), the assessment of headache days per month was not conducted at baseline and after 2 treatment cycles (n = 3), or the patient did not have CM (n = 1)
Review of the medical records revealed no serious adverse events attributable to onabotulinumtoxinA. In this retrospective review of medical records from 211 patients with CM treated with PBS-subsidized onabotulinumtoxinA in Australia, the data showed a reduction in headache frequency at 2 treatment cycles and beyond
Summary
OnabotulinumtoxinA (BOTOX®, Allergan plc, Dublin, Ireland) is approved for the preventive treatment of headaches in adult patients with chronic migraine (CM) in Australia by the country’s reimbursement mechanism for medicines, the Pharmaceutical Benefits Scheme (PBS). Continued PBS reimbursement eligibility depends on achieving and maintaining a 50% or greater reduction from baseline in the number of headache days per month after two 12-week treatment cycles This positive treatment response at 24 weeks aligns with results from the pivotal phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) randomized trials, which found onabotulinumtoxinA injections to be well tolerated and significantly more effective than placebo for reducing headache days at week 24 [11, 12]. These findings were further supported in the Chronic Migraine OnabotulinumtoxinA Prolonged Efficacy OpenLabel (COMPEL) study, which evaluated longer-term use of onabotulinumtoxinA (108 weeks/9 cycles) in Australia, South Korea, and the United States [13]
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