TerbinafineAPO-TERBINAFINE
Treatment of fungal or yeast infection (tablets for dermatophyte infections; cream for fungal or yeast infections) in Aboriginal or Torres Strait Islander persons.
Decisions on record
- Meeting May 2020 Noted Onychomycosis no PSD
- Meeting Nov 2009 Recommended Fungal infections no PSD
- Meeting Nov 2007 Recommended Fungal infections
- Meeting Nov 2007 Recommended Fungal infections
Access path
- TGA registered · APO-TERBINAFINE
TGA label narrower than the PBS population
- Nov 2007Recommended · restricted
vs griseofulvin (tablet); miconazole (cream)
- Nov 2007Recommended · restricted
- PBS listing · Authority Required
Cost-effectiveness
Tablet: trial-based economic evaluation estimated incremental cost of <$500 per extra patient successfully treated. Cream: cost-minimisation approach; no ICER calculated. No modelled economic evaluation presented.
The PBAC considered that the trial-based cost-minimisation data should be regarded as indicative only and that the additional cost of listing terbinafine would be magnified if the incidence were higher than estimated, or if treatment were prolonged. PBAC · 2007
Decision context
PopulationAboriginal or Torres Strait Islander adults with dermatophyte, tinea, or candida infections where oral (tablet) or topical (cream) therapy is indicated.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended · restricted | griseofulvin (tablet); miconazole (cream) | — | RCT · Mycological cure / complete cure, Clinical efficacy |
| Nov 2007 | Recommended · restricted | griseofulvin (tablet); miconazole (cream) | — | RCT · mycological cure |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts subsidy to Aboriginal or Torres Strait Islander persons only; TGA label covers all adults without ethnic restriction.