PBAC's latest decision on Pimecrolimus: Recommended with restriction (2006). Considered for Treatment of facial or eyelid atopic dermatitis in patients aged at least 3 months with contraindications to topical corticosteroids, and short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged at least 3 months who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy.
PBAC outcome
Recommended with restriction
Authority required
ICER (AUD/QALY)
$15k/QALY
Base-case
Submissions
1
first 2006
Submissions
1
2006 → 2006
Eligible population
patients aged at least 3 months with contraindications to topical corticosteroids, and short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged at least 3 months who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy
Therapy area
Dermatology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
QoL | ORR
Key trials
C2442, DE-01, B308
Comparator
topical corticosteroids (TCS) or vehicle
Economic model
CUA
Risk sharing
Risk-sharing arrangement in place — The sponsor committed to maintaining the risk sharing threshold for pimecrolimus at its current level (that is based on the listing in children and adolescents only).