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Tazarotene

Not recommended DermatologyRestrictedFirst-line line

Chronic stable plaque type psoriasis vulgaris.

2
Submissions
1 resub
2007–07
On the record
—
ICER range
Cost-min
Cost basis

Decision on record

1 decision
  • Meeting Jul 2007 Not recommended Psoriasis

Access path

2 submissions · public record
  1. Jul 2007
    Not recommended

    Uncertain clinical benefit in comparison with calcipotriol, formulation mismatch (key trials used gel not cream)…

  2. Jul 2007
    Not recommended

    uncertain comparative efficacy versus calcipotriol, key trials used tazarotene gel not cream (product for listing)…

RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation approach presented; economic analysis deemed invalid by PBAC due to uncertain comparative efficacy. No modelled economic evaluation presented.

In view of PBAC's conclusions regarding the comparative efficacy of tazarotene and calcipotriol, the economic analysis was not considered valid by the Committee. PBAC · 2007
ICER uncertainEconomic model disputed

Decision context

PopulationAdults with chronic stable plaque type psoriasis vulgaris.

Why it was knocked back

  • uncertain comparative efficacy versus calcipotriol, key trials used tazarotene gel not cream (product for listing), sparse adverse event data suggesting tazarotene may have higher incidence of adverse events, gel appeared to perform better than cream, Guenther trial used inappropriate combination comparison, calcipotriol appeared more effective in R168-145-8606, Tzung trial small and inconclusive, Schiener trial underpowered with wide confidence intervals

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Jul 2007 Not recommended calcipotriol — RCT | Single-arm · Treatment success, mean change from baseline in erythema, pruritus, plaque elevation and scaling
Jul 2007 Not recommended calcipotriol — RCT

Similar precedents

By decision profile
Calcipotriol With Betamethasone Dipropionate, Ointment73%Calcipotriol With Betamethasone Dipropionate72%Calcipotriol + Betamethasone Dipropionate70%Coal Tar Prepared64%Clobetasol Propionate64%Imiquimod64%Imiquimod, Cream61%Efalizumab60%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to chronic stable plaque psoriasis vulgaris as first-line, excluding acne and other psoriasis types from TGA label.