PBAC's latest decision on Clobetasol propionate: Not recommended (2024). Considered for Severe or resistant corticosteroid-responsive dermatoses in adults requiring treatment with a very-high potency topical corticosteroid after failure of lower potency agents.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2013
Submissions
2
2013 → 2024
Eligible population
Adults aged 18 years or older with severe or resistant corticosteroid-responsive dermatoses (excluding widespread plaque psoriasis) who have previously failed treatment with lower potency topical corticosteroids.
Therapy area
Dermatology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Disease severity (signs and symptoms), physician and patient rating of overall clinical response
betamethasone dipropionate 0.05% cream and ointment
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach used; no ICER calculated.
Why PBAC said no
Reasons cited in the latest PSD: Fundamental problems with dose equivalence calculations exceeding product information safety limits, inconsistencies between proposed restriction and treatment algorithm, unclear place in therapy, poor quality direct comparative trial evidence, concerns about systemic adverse effects and HPA suppression with extended use, no evidence that severe cases require very-high potency TCS, insufficient rationale for equity claim given non-inferiority to comparator
Submission history
Nov 2013: Recommended with restriction · Authority Required