PBAC's latest decision on Modafinil; armodafinil: Noted (2020). Considered for Treatment of narcolepsy with excessive daytime sleepiness. The submission sought to amend PBS restrictions to reflect contemporary guidelines allowing modafinil and armodafinil as first-line therapy, and to remove the requirement to resubmit sleep study reports before switching between the two agents.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2020
Submissions
1
2020 → 2020
Eligible population
Patients with narcolepsy and excessive daytime sleepiness, with definite history of cataplexy or mean sleep latency ≤10 minutes on MSLT, who have contraindication or intolerance to dexamfetamine sulfate, treated by qualified sleep medicine practitioner or neurologist.
Therapy area
Neurology
Line of therapy
First-line
Evidence base
Meta-analysis
Primary endpoint
MWT (Maintenance of Wakefulness Test); mean sleep latency
Key trials
Golicki et al (systematic review and meta-analysis); Lehert and Falissard (network meta-analysis); Mitler et al; Schindler et al
Comparator
placebo (for efficacy); dexamfetamine (for alternative therapy comparison)
Economic model
not-modelled
ICER note
Minor submission with no economic analysis presented. PBAC noted in November 2008 submission that modafinil and dexamfetamine had drug costs of $3327 vs. $318 per year, but no ICER calculated in this resubmission.