DapsoneAczone

Recommended DermatologyUnrestrictedNot applicable line

Dermatitis herpetiformis, leprosy, and actinomycotic mycetoma.

Submissions

2025–25

On the record

—

ICER range

Cost-min

Cost basis

Decision on record

1 decision

Meeting Mar 2025 Recommended Dermatitis herpetiformis, leprosy, actinomycotic mycetoma

Access path

1 submission · public record

TGA registered · Aczone
TGA label equal than the PBS population
Mar 2025
Recommended
vs dapsone 25 mg tablet (DAPSONE)
PBS listing · Unrestricted

RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications

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

1 entries

Decided	Outcome	Comparator	ICER	Evidence
Mar 2025	Recommended	dapsone 25 mg tablet (DAPSONE)	—	Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile

Calcipotriol + Betamethasone Dipropionate62%Calcipotriol With Betamethasone Dipropionate, Ointment61%Isotretinoin61%Medroxyprogesterone Acetate61%Tacrolimus61%Daclizumab60%Clobetasol Propionate60%Risperidone60%

Regulatory · TGA

Label equal than PBS population — Both specify identical indications (dermatitis herpetiformis, leprosy, actinomycotic mycetoma) with no population restrictions applied.

Product Information ↗ ARTG search ↗

Listed in law

Federal Register of Legislation

PBS listings commencing 1 Jan 2026 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.

Determination	Made	Status
PB 152 of 2025	23 Dec 2025	Repealed	PDF ↗
PB 153 of 2025	23 Dec 2025	Repealed	PDF ↗
PB 154 of 2025	23 Dec 2025	Repealed	PDF ↗