PBAC's latest decision on Crisaborole: Deferred (2020). Considered for Mild to moderate atopic dermatitis in patients aged at least 2 years who have failed to achieve satisfactory disease control with, are contraindicated or intolerant to topical corticosteroids.
PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2018
Submissions
2
2018 → 2020
Eligible population
Patients aged ≥2 years with mild to moderate atopic dermatitis (with erythematous patches and induration/papulation) who have failed maximum tolerated doses of topical corticosteroids (including intermittent use), or are intolerant or contraindicated to topical corticosteroids.
Therapy area
Dermatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
ISGA
Key trials
AD-301, AD-302, AD-303
Comparator
pimecrolimus (face and eyelids) and standard management (rest of body)
Economic model
CUA
ICER note
Cost-minimisation analysis compared to pimecrolimus; cost-effectiveness analysis compared to standard management. Numeric ICER values not stated in the document.
Risk sharing
Risk-sharing arrangement in place — RSA mentioned as potentially required to address likelihood of leakage outside the restriction. Sponsor stated willingness to consider an RSA based on estimates of use, but detailed estimates were not provided.