PBAC's latest decision on Methyl 5-aminolevulinate hydrochloride: Not recommended (2008). Considered for Treatment of superficial basal cell carcinoma (sBCC) in patients for whom surgical excision, cryotherapy, or curettage with diathermy are inappropriate and topical drug therapy is required.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2007
Submissions
2
2007 → 2008
Eligible population
Patients aged 18 years or older with primary, previously untreated superficial basal cell carcinoma (sBCC) where surgical excision, cryotherapy, or curettage with diathermy are inappropriate.
Therapy area
Dermatology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
ORR
Key trials
T307, T308, T304, T310, T205
Comparator
imiquimod
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis was performed, not a cost-utility or cost-effectiveness analysis with an ICER.
Why PBAC said no
Reasons cited in the latest PSD: uncertain comparative effectiveness (lack of scientific rigour in studies, non-inferiority claim not supported), higher recurrence rates with MAL-PDT than imiquimod at 2 and 5 years, problems with the cost-minimisation analysis (uncertainty about appropriate number of imiquimod sachets, inappropriate exclusion of non-government costs)