PBAC's latest decision on Imiquimod: Not recommended (2008). Considered for treatment of solar keratosis on the face or scalp in a patient with normal immune function who has multiple clinically evident lesions and requires topical drug treatment as field therapy.
PBAC outcome
Not recommended
2008
ICER (AUD/QALY)
—
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
patients with normal immune function who have multiple clinically evident solar keratosis lesions on the face or scalp requiring topical drug treatment as field therapy
Therapy area
Dermatology
Evidence base
RCT, Single-arm
Primary endpoint
QoL
Key trials
H2H, Foley
Comparator
topical 5-fluorouracil (Efudix®)
Economic model
CUA
ICER note
ICER was modelled and stated in the submission ($195 per recurrence-free year vs 5-FU at 3 years), but PBAC rejected the application on grounds of uncertain evidence of effectiveness and safety, and uncertain cost-effectiveness. The economic model structure was considered inappropriate for the disease.
Why PBAC said no
Reasons cited in the latest PSD: uncertain evidence of effectiveness and safety over the comparator, uncertain cost-effectiveness, safety concerns regarding use over areas greater than 25 cm² (TGA approval limit) when sachets can cover up to 389 cm², no safety data for sequential use on different skin patches, potential for systemic side effects with larger skin areas, pivotal H2H trial involved very small number of patients and was unblinded, economic model structure inappropriate for solar keratosis (longer disease course than BCC for which model was designed)