Calcipotriol With Betamethasone DipropionateActobet 50/500
Treatment of chronic stable plaque type psoriasis vulgaris, including scalp psoriasis and mild to moderate plaque psoriasis on the body in adults, when inadequately controlled by potent topical corticosteroid monotherapy.
Decisions on record
- Meeting Nov 2025 Recommended Chronic stable plaque type psoriasis vulgaris of scalp and body
- Meeting Jul 2025 Recommended Chronic stable plaque psoriasis vulgaris inadequately responding to potent topical corticosteroid
- Meeting Jul 2023 Not recommended Chronic stable plaque type psoriasis vulgaris
- Meeting Nov 2010 Recommended Psoriasis no PSD
- Meeting Jul 2009 Recommended Psoriasis
Access path
- TGA registered · Actobet 50/500
TGA label narrower than the PBS population
- Nov 2016Recommended · restricted
vs calcipotriol plus betamethasone gel
- Mar 2018Not recommended
limited clinical need based on utilisation data showing majority of patients already covered by existing arrangements…
- Jul 2023Not recommended
Evidence: RCT → Cost-minimisation
- ↻ resubmittedJul 2025Recommended · restricted
Evidence: Cost-minimisation → RCT
- Nov 2025Recommended
Comparator changed: calcipotriol with betamethasone dipropionate foam (primary)…
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the listing of calcipotriol + betamethasone (Actobet) for the treatment of chronic stable plaque type psoriasis vulgaris under a General Schedule listing on a cost-minimisation basis to cal/bet ointment.PSD · Nov 2025
6.2 The PBAC deemed the equi-effective doses to be 1 mg Actobet = 1 mg cal/bet ointment.PSD · Nov 2025
5.10 As a Category 4 submission, the economic analysis has not been independently evaluated.PSD · Nov 2025
5.11 The submission presented a cost-minimisation approach of Actobet Gel compared with cal/bet ointment. The equi-effective doses were estimated as Actobet Gel 1g for Daivobet Gel 1g based on a determination of bioequivalence. The CMA was then based on a PBAC recommendation in July 2009 for cal/bet ointment on cost- minimisation approach against Daivobet Gel. 4PSD · Nov 2025
5.7 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of Actobet compared with Daivobet.PSD · Nov 2025
5.8 The PBAC considered that the claim of non-inferior effectiveness was reasonable.PSD · Nov 2025
The comments described how a gel formulation of cal/beta would be superior for use 3PSD · Nov 2025
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The PBAC agreed that the estimated financial impact was reasonable. The PBAC noted that a small net save to the PBS/RPBS was expected. PBAC · 2025
Decision context
PopulationAdults with chronic stable plaque type psoriasis vulgaris on the scalp and body, inadequately controlled by potent topical corticosteroid monotherapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | calcipotriol + betamethasone ointment | — | RCT · PASI |
| Jul 2025 | Recommended · restricted | calcipotriol with betamethasone dipropionate foam (primary); calcipotriol with betamethasone dipropionate ointment (seco | — | RCT · PFS |
| Jul 2023 | Not recommended | — | — | Cost-minimisation · Cost-minimisation |
| Mar 2018 | Not recommended | — | — | RCT · Other |
| Nov 2016 | Recommended · restricted | calcipotriol plus betamethasone gel | — | RCT · IGA |
Consumer voice
The Australasian College of Dermatologists noted that a gel formulation of cal/beta would be superior for use on the scalp and trauma-prone body areas because it was easier to apply compared to ointment and cream formulations.
The comments described how a gel formulation of cal/beta would be superior for use on the scalp and trauma-prone aspects of the body because it was easier to apply, compared to ointment and cream formulations. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to inadequate control despite potent topical corticosteroid monotherapy; TGA label has no prior treatment requirement.