Clobetasol PropionateCLOBEX Shampoo
Recommended DermatologyRestrictedLater-line line 💬 consumer voice
Severe or resistant corticosteroid-responsive dermatoses in adults requiring treatment with a very-high potency topical corticosteroid after failure of lower potency agents.
2
Submissions
1 resub
2013–24
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2024 Recommended Corticosteroid-responsive dermatoses
- Meeting Nov 2013 Recommended 500 microgram per mL shampoo for topical application, 125 mL Galderma Australia Pty Ltd Major submission Moderate to severe scalp psoriasis Restricted Benefit listing for the treatment of adults with moderate to severe scalp psoriasis who are not adequately controlled with either a vitamin D analogu
Access path
- TGA registered · CLOBEX Shampoo
TGA label narrower than the PBS population
- Nov 2013Recommended · restricted
vs betamethasone dipropionate plus calcipotriol (Daivobet)
- Nov 2024Recommended · restricted
Comparator changed: betamethasone dipropionate plus calcipotriol (Daivobet) →…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the General Schedule, Restricted Benefit listing of clobetasol propionate 0.05% cream and ointment for the treatment of corticosteroid-responsive dermatoses in patients who have inadequately responded to lower potency topical corticosteroids (TCS).PSD · Nov 2024
7.2 The PBAC considered the equi-effective doses were clobetasol propionate 0.05% 1 gram = betamethasone dipropionate 0.05% 1 gram. The Committee noted that in practical terms, dosing would likely be administered in finger-tip units (FTU) of approximately 0.5 grams (see paragraph 6.37).PSD · Nov 2024
Economic analysis
6.27 The submission presented a cost-minimisation approach. The key components are shown in Table 6.PSD · Nov 2024
6.28 The equi-effective doses were estimated by the submission as clobetasol propionate 7 g daily over 14 days and betamethasone dipropionate 7 g daily over 14 days, based on 4 the randomised trials (Jacobson 1986, Mauracher 1983, Verdich 1985, Yawalker 1991) described in Table 4.PSD · Nov 2024
Clinical claim
6.23 The submission described clobetasol propionate as non-inferior in terms of effectiveness compared to betamethasone dipropionate. Although the available evidence was of poor quality, on balance, the ESC considered the non-inferiority claim was reasonable.PSD · Nov 2024
6.24 The submission described clobetasol propionate as non-inferior in terms of safety compared to betamethasone dipropionate. This claim could not be assessed on the basis of the head-to-head evidence presented. Taking the available evidence as a whole, it is likely that more frequent and more severe systemic adverse events will 14PSD · Nov 2024
Consumer comments
6.2 The PBAC noted and welcomed the input from the Australasian College of Dermatologists which supported the listing, and stated the listing of clobetasol cream and ointment would provide specialist dermatologists with an additional option when treating complex and/or chronic cases of dermatoses.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation approach used; no ICER calculated.
The PBAC considered that whilst the supporting trial evidence was generally poor and lacking in relevant detail, when considering the totality of the evidence including the systematic review presented, the claims of non-inferior comparative effectiveness were on balance, likely to be reasonable. PBAC · 2024
Cost-effectiveness accepted ×2
Decision context
PopulationAdults 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.
Why it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | betamethasone dipropionate 0.05% cream and ointment | — | RCT · Disease severity (signs and symptoms), physician and patient rating of overall clinical response |
| Nov 2013 | Recommended · restricted | betamethasone dipropionate plus calcipotriol (Daivobet) | — | RCT · IGA |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT01195831 | Ph 3 | 244 | Patients With "Controlled Disease" in Terms of "Clear" or "Minimal" According to Investiga… | completed |
Consumer voice
The Australasian College of Dermatologists supported the listing, indicating that clobetasol cream and ointment would provide specialist dermatologists with an additional treatment option for complex and/or chronic dermatoses.
the listing of clobetasol cream and ointment would provide specialist dermatologists with an additional option when treating complex and/or chronic cases of dermatoses Consumer comments · PSD
treatment optionsspecialist accessunmet need
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults with prior treatment failure with lower potency agents; TGA label has no such prior therapy requirement.