Adapalene With Benzoyl PeroxideEpiduo Forte
Recommended DermatologyRestricted benefitNot applicable line
acute treatment, in combination with an oral antibiotic, of severe acne vulgaris; maintenance treatment of severe acne vulgaris
1
Submissions
2010–10
On the record
$45k–75k
ICER range
1 sourced ICER · 2010
ICER stated
Cost basis
Decision on record
- Meeting Nov 2010 Recommended Acne
Access path
- TGA registered · Epiduo Forte
TGA label narrower than the PBS population
- Nov 2010Recommended · restricted
vs placebo
- PBS listing · Restricted benefit
RecommendedDeferredNot recommended
Cost-effectiveness
Base-case ICER was $15,000–$45,000/QALY; sensitivity analyses increased ICER to $45,000–$75,000/QALY using lower bound of 95% CI for odds ratio and smaller utility gain.
The PBAC considered that the 12-week results of the ACCESS-1 trial presented in the submission support the claim of superior comparative effectiveness of adapalene with benzoyl peroxide adjunctive therapy with doxycycline over doxycycline. The PBAC considered that the results of the ACCESS-2 trial, which compared adapalene plus benzoyl peroxide monotherapy with placebo, generally support the maintenance of benefit of treatment with adapalene with benzoyl peroxide in patients who have achieved an initial response with adapalene with benzoyl peroxide as adjunctive therapy to oral antibiotics. PBAC · 2010
ICER uncertainSurrogate endpoint
Decision context
Populationpatients with severe acne vulgaris
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Recommended · restricted | placebo | $45k–75k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe acne vulgaris requiring oral antibiotics, versus TGA label covering acne after first-line treatment failure.