DapsoneAczone
Recommended DermatologyUnrestrictedNot applicable line
Dermatitis herpetiformis, leprosy, and actinomycotic mycetoma.
1
Submissions
2025–25
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2025 Recommended Dermatitis herpetiformis, leprosy, actinomycotic mycetoma
Access path
- TGA registered · Aczone
TGA label equal than the PBS population
- Mar 2025Recommended
vs dapsone 25 mg tablet (DAPSONE)
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended a General Schedule Unrestricted Benefit listing of a new 50 mg strength of dapsone (Dapsomed®; hereafter referred to as DAPSOMED) under the same conditions as the currently listed strengths of dapsone and on a cost- minimisation basis to the 25 mg tablet (Link Medical Products Dapsone; hereafter referred to as DAPSONE).PSD · Mar 2025
5.2 The PBAC noted that the TGA considered DAPSOMED to be bioequivalent to DAPSONE.PSD · Mar 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the submission compared bioequivalent formulations on a cost basis only.
The PBAC considered the estimated net save was reasonable. PBAC · 2025
Cost-effectiveness accepted
Decision context
PopulationPatients with dermatitis herpetiformis, leprosy, or actinomycotic mycetoma requiring dapsone therapy, with 50 mg being the TGA-approved starting dose.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended | dapsone 25 mg tablet (DAPSONE) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify identical indications (dermatitis herpetiformis, leprosy, actinomycotic mycetoma) with no population restrictions applied.