PBAC's latest decision on Armodafinil: Recommended with restriction (2016). Considered for Treatment of narcolepsy in patients with excessive daytime sleepiness who have failed or are intolerant to dexamphetamine sulfate.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2015
Submissions
2
2015 → 2016
Eligible population
Patients with narcolepsy defined by excessive daytime sleepiness occurring almost daily for at least 3 months, with definite history of cataplexy OR mean sleep latency ≤10 minutes on MSLT OR pathologically rapid REM sleep on EEG, who are contraindicated for or intolerant to dexamphetamine sulfate, and treated by a qualified sleep medicine practitioner or neurologist.
Therapy area
Neurology
Line of therapy
Second-line
Evidence base
Single-arm
Primary endpoint
Comparative effectiveness (non-inferiority)
Key trials
Trial 3020 (Harsh et al 2006), Fry 1998, Gross 2000
Comparator
modafinil
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. The submission claimed cost-neutrality based on non-inferiority of armodafinil to modafinil.
Submission history
Nov 2015: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Authority Required