PBAC's latest decision on Tacrolimus: Recommended with restriction (2025). Considered for Moderate to severe atopic dermatitis in patients aged 16 years and older who have failed to achieve satisfactory disease control with topical corticosteroids or are unsuitable/contraindicated for topical corticosteroids.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
5
first 2007
Submissions
5
2007 → 2025
Eligible population
Adults aged 16 years and older with moderate to severe atopic dermatitis affecting any part of the body, including face and eyelids, who have failed to achieve satisfactory disease control with intermittent topical corticosteroid therapy despite appropriate dose, duration and adherence, or who are unsuitable/contraindicated for topical corticosteroids.
Therapy area
Dermatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Disease severity (EASI score, physician and patient rating of overall clinical response, %BSA affected)
Pivotal trial size
579 patients
Key trials
Hanifin et al (2001), Drake et al (2001)
Comparator
Vehicle ointment (VO) and 1% pimecrolimus (PIM)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis compared to vehicle ointment and 1% pimecrolimus; no numeric ICER stated in the public text.
Submission history
Nov 2007: Recommended with restriction · Authority Required
Mar 2008: Recommended with restriction · Authority Required
Mar 2016: Recommended · Restricted
Nov 2019: Recommended · Unrestricted
Jul 2025: Recommended with restriction · Authority Required