Modafinil; Armodafinil
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.
Decisions on record
- Meeting May 2022 Recommended Narcolepsy
- Meeting Nov 2021 Not recommended Narcolepsy no PSD
From the public summary
4.1 The PBAC recommended the listing of modafinil and armodafinil as first-line treatment for patients with narcolepsy on a cost-minimisation basis to dexamfetamine. 5PSD · May 2022
4.2 The PBAC noted that, under section 101(3B) of the Act, a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies is required to recommend armodafinil or modafinil at a higher price than dexamfetamine. The PBAC considered that there was no clinical evidence to suggest that modafinil or armodafinil have superior comparative effectiveness or safety compared to dexamfetamine.PSD · May 2022
The PBAC previously considered that the omission of an economic analysis was inappropriate (section 12, modafinil Public Summary Document (PSD), November 2008 PBAC Meeting).PSD · Jul 2020
The submission claimed superior comparative effectiveness and safety of modafinil and armodafinil compared with dexamfetamine.PSD · Jul 2020
No clinical evidence comparing modafinil and armodafinil to dexamfetamine was provided to support the clinical claim.PSD · Jul 2020
Cost-effectiveness
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.
Decision context
PopulationPatients 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Deferred | placebo (for efficacy); dexamfetamine (for alternative therapy comparison) | — | Meta-analysis · MWT (Maintenance of Wakefulness Test); mean sleep latency |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to narcolepsy patients with documented cataplexy or MSLT ≤10 min, excluding other TGA-labeled sleep disorders.