Botox® Showing Good Results for Chronic Migraine: PBAC seeks your views
The use of Botox® for chronic migraine has been increasing since it was listed on the Pharmaceutical Benefits Scheme (PBS), and now it appears to be more effective than expected at reducing the number of headache days and related reductions in use of medications including opioids.
In a study published in the Journal of Neurology, Neurosurgery & Psychiatry of 211 patients using PBS-subsidised Botox® for chronic migraine, 74% obtained 50% or greater reduction in headache days per month (from a mean of 25 to 11 days). Acute medication intake reduced from a mean of 19 to 7 days per month and the proportion of patients using opioids also decreased significantly, with over-the-counter codeine dropping from 44% to 28% and prescription opioids from 23% to 13%.
These results appear to support the higher than expected numbers of patients with chronic migraine being treated with Botox® in the first and second year of listing on the PBS. According to a report by the Drug Utilisation Sub-Committee (DUSC), there were 3,517 and 5,444 patients treated with Botox® for chronic migraine with 7,826 and 13,873 services respectively in the first and second years. The continuation rate on treatment at 24 weeks was 71.4%, more than double that predicted from the clinical trial data (32.9%).
These findings have led Allergan Australia (the sponsor of with Botox®) to make a major submission to the Pharmaceutical Benefits Advisory Committee (PBAC) to request a revision to the existing risk sharing arrangements.
The PBAC would like to hear from patients and clinicians who have used Botox® for chronic migraine, to better understand the effectiveness of the drug, side effects, difficulty or ease of compliance with the dosing regimen and specialist visits, and the impact of the drug on patients’ everyday lives.
The PBAC has previously had concerns that some patients may be only experiencing a partial response but continue to be prescribed the treatment, or that patients may continue to use the treatment for its cosmetic benefits even if they do not achieve the required reduction in headache days..
Botulinum toxin type A (Botox®) has been indicated for chronic migraine in adults since listing on the PBS in March 2014. In the authority required, patients must have attempted to use at least three migraine medications (without success) and they must have achieved and maintained a 50% or greater reduction in the number of headache days per month after two treatment cycles (each of 12 weeks duration) in order to be eligible for PBS-subsidised treatment.
To make an online submission to the PBAC please complete the form on the following page and select Botulinum toxin type A from the drop down menu at “Medicine Names” by 7 February2018:
http://www.health.gov.au/internet/main/publishing.nsf/Content/PBAC_online_submission_form