ModafinilAPO-MODAFINIL
First-line treatment of narcolepsy in patients with excessive daytime sleepiness, recurrent naps, or sleep lapses occurring almost daily for at least 3 months, with definite cataplexy history or mean sleep latency ≤10 minutes on MSLT.
Decisions on record
- Meeting Mar 2009 Recommended Narcolepsy no PSD
- Meeting Nov 2008 Not recommended Promotes wakefulness
- Meeting Nov 2006 Recommended Narcolepsy no PSD
Access path
- TGA registered · APO-MODAFINIL
TGA label narrower than the PBS population
- Nov 2008Recommended
vs dexamphetamine (first-line) and placebo (second-line)
- PBS listing · Authority Required
Cost-effectiveness
No economic analysis was presented in the submission; PBAC considered the omission of economic analyses inappropriate.
The PBAC considered that the omission of economic analyses was inappropriate. PBAC · 2008
Decision context
PopulationPatients with narcolepsy meeting diagnostic criteria including excessive daytime sleepiness occurring almost daily for ≥3 months, definite cataplexy history or mean sleep latency ≤10 minutes on MSLT preceded by nocturnal polysomnography with ≥6 hours sleep, and absence of alternative medical/psychiatric causes of hypersomnia.
Why it was knocked back
- insufficient evidence that placebo rather than dexamphetamine is appropriate comparator for first-line modafinil, insufficient evidence to substantiate that eligible patients are being denied treatment under current restriction, omission of economic analyses, uncertain long-term relative net clinical effect, large price difference between modafinil ($3327/year) and dexamphetamine ($318/year) without established incremental benefit
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Recommended | dexamphetamine (first-line) and placebo (second-line) | — | RCT · Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to narcolepsy with specific diagnostic criteria (cataplexy or MSLT ≤10 min) and ≥3 months duration; TGA label includes all narcolepsy patients.