PBAC's latest decision on Modafinil: Not recommended (2008). Considered for 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.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
Patients 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.
Therapy area
Neurology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
118 patients
Key trials
Black (2006)
Comparator
dexamphetamine (first-line) and placebo (second-line)
Economic model
Not modelled
Budget impact
$10M
Eligible patients/year
10,000
ICER note
No economic analysis was presented in the submission; PBAC considered the omission of economic analyses inappropriate.
Why PBAC said no
Reasons cited in the latest PSD: 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