PBAC's latest decision on Imiquimod, cream: Not recommended (2009). Considered for treatment of solar (actinic) keratosis in the face and the scalp, primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and the treatment of external genital and peri-anal warts (Condyloma acuminata) in adults.
PBAC outcome
Not recommended
2009
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2005
Submissions
3
2005 → 2009
Eligible population
adults with solar (actinic) keratosis on the face or scalp in a patient with normal immune function who has multiple clinically evident solar keratosis lesions and requires topical drug treatment as field therapy
Therapy area
Dermatology
Evidence base
RCT | Other
Key trials
Krawtchenko et al., 2007
Comparator
5-flurouracil and cryotherapy
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis determined appropriate; ICER not calculated. Cost-minimisation analysis found imiquimod significantly more expensive than comparators.
Why PBAC said no
Reasons cited in the latest PSD: Lack of data to support value in treating solar keratosis, no reliable evidence of superiority over comparators (5-flurouracil and cryotherapy), lack of safety data for treatment surface areas exceeding 25 cm², imiquimod more expensive than comparators on cost-minimisation analysis, absence of data on QALY outcomes, no reliable data on duration of treatment effect after 16 months, inadequate demonstration of superiority over comparator therapies
Submission history
Nov 2005: Not recommended · Authority Required
Jul 2006: Recommended with restriction · Authority Required