TopiramateAPO-TOPIRAMATE
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.
Decision on record
- Meeting Mar 2007 Recommended Anti-epileptic and migraine prophylaxis
Access path
- TGA registered · APO-TOPIRAMATE
TGA label narrower than the PBS population
- Jul 2006Not recommended
uncertain benefit in the population in whom listing was requested, uncertain applicability of trial results to intended…
- Jul 2006Not recommended
uncertain applicability of trial results to intended PBS population (trials excluded patients who failed more than two…
- ↻ resubmittedMar 2007Recommended · restricted
- PBS listing · Authority Required
From the public summary
The trial-based incremental cost/extra responder gained was estimated to be <$15,000. The trial-based incremental cost/extra migraine day avoided was estimated to be <$15,000.PSD · Mar 2007
An updated modelled economic evaluation was presented. The approach and structure of the modelled economic evaluation were unchanged from the previous submission.PSD · Mar 2007
Cost-effectiveness
The trial-based incremental cost/extra responder gained was estimated to be <$15,000. The trial-based incremental cost/extra migraine day avoided was estimated to be <$15,000. PSD · 2007
Decision context
Populationpatients 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2007 | Recommended · restricted | placebo | $15k–45k | RCT · QoL |
| Jul 2006 | Not recommended | placebo | $15k–45k | RCT · responder rate, defined as the proportion of subjects who had a 50% or greater reduction in their average monthly migraine period rate from baseline |
| Jul 2006 | Not recommended | placebo | $15k–45k | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with ≥3 migraines/month over 6 months, failed/contraindicated beta-blockers, and BMI>30 or pizotifen intolerance.