PBAC's latest decision on Topiramate: Recommended with restriction (2007). Considered for prophylaxis of migraine in an adult who has experienced an average of three or more migraines per month over a period of at least six months, and who: (a) has a contraindication to beta-blockers; OR (b) has experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND (c) has a Body Mass Index (BMI) >30 kg/m2; OR (d) has experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
2
first 2006
Submissions
2
2006 → 2007
Eligible population
patients who have experienced an average of three or more migraines per month over a period of at least six months, and who: (a) has a contraindication to beta-blockers; OR (b) has experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta-blocker; AND (c) has a Body Mass Index (BMI) >30 kg/m2; OR (d) has experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.
Therapy area
Neurology
Line of therapy
Initial treatment
Evidence base
RCT
Primary endpoint
QoL
Key trials
Silberstein et al 2004, Brandes et al 2004
Comparator
placebo
Economic model
Cost-minimisation
Budget impact
$30M
Eligible patients/year
10,000
ICER basis
Range aggregates 2 submissions (2006–2007) — not a single base case.
Submission history
Jul 2006: Not recommended — ICER $45k/QALY
Mar 2007: Recommended with restriction · Authority Required — ICER $45k/QALY