ArmodafinilNUVIGIL
Treatment of narcolepsy in patients with excessive daytime sleepiness who have failed or are intolerant to dexamphetamine sulfate.
Decisions on record
- Meeting Jul 2020 Deferred Narcolepsy
- Meeting Mar 2016 Recommended Narcolepsy
- Meeting Nov 2015 Not recommended Narcolepsy
Access path
- TGA registered · NUVIGIL
TGA label narrower than the PBS population
- Nov 2015Not recommended
vs modafinil
- ↻ resubmittedMar 2016Recommended · restricted
Evidence: Meta-analysis → Single-arm
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended an Authority Required listing for armodafinil for the treatment of narcolepsy on a cost-minimisation basis with modafinil. The PBAC considered the equi-effective doses to be armodafinil 250 mg and modafinil 348.55 mg, resulting in a dose relativity of 5:7 as proposed by the resubmission.PSD · Mar 2016
7.2 In making its recommendation, the PBAC considered that the revised equi-effective doses presented in the re-submission were reasonable. The PBAC also noted that it 7PSD · Mar 2016
6.8 In the previous major submission considered by the PBAC in November 2015, the submission presented a cost-minimisation analysis against modafinil.PSD · Mar 2016
6.9 The previous submission estimated the equi-effective doses as armodafinil 216.39 mg and modafinil 349.65 mg, and a dose relativity of 5:8 (armodafinil vs modafinil) was used to determine the requested price for armodafinil.PSD · Mar 2016
6.7 At its November 2015 meeting, the PBAC considered that the data presented in the submission suggested that armodafinil may be non-inferior to modafinil in terms of comparative efficacy and safety.PSD · Mar 2016
6.2 The PBAC noted and welcomed the input from health care professionals (4) via the Consumer Comments facility on the PBS website. The comments described some of the perceived benefits of treatment with armodafinil including better symptom control and convenience of single dose treatment.PSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. The submission claimed cost-neutrality based on non-inferiority of armodafinil to modafinil.
In making its recommendation, the PBAC considered that the revised equi-effective doses presented in the re-submission were reasonable. PBAC · 2016
Decision context
PopulationPatients 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | modafinil | — | Single-arm · Comparative effectiveness (non-inferiority) |
| Nov 2015 | Not recommended | modafinil | — | Meta-analysis · MWT |
Consumer voice
Healthcare professionals provided input describing perceived benefits of armodafinil treatment, including better symptom control and the convenience of single dose treatment.
The comments described some of the perceived benefits of treatment with armodafinil including better symptom control and convenience of single dose treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to narcolepsy patients only, excluding shift work disorder and obstructive sleep apnoea indications in the TGA label.