PBAC's latest decision on Methyl aminolevulinate: Not recommended (2005). Considered for Treatment of patients aged 18 years or older with primary superficial basal cell carcinoma (sBCC) or nodular basal cell carcinoma (nBCC) where surgery is inappropriate due to the risk of post-surgical morbidities or disfigurement.
PBAC outcome
Not recommended
2005
ICER (AUD/QALY)
—
Submissions
1
first 2005
Submissions
1
2005 → 2005
Eligible population
patients aged 18 years or older with primary superficial basal cell carcinoma (sBCC) or nodular basal cell carcinoma (nBCC) where surgery is inappropriate due to the risk of post-surgical morbidities or disfigurement
Therapy area
Oncology
Evidence base
RCT
Primary endpoint
patient complete response and lesion recurrence
Key trials
Trial T303
Comparator
surgical excision
Economic model
CUA | CEA
ICER note
ICER stated as '<$15,000' (trial-based and modelled analyses), but PBAC rejected submission on multiple grounds including uncertain and inadequately demonstrated cost-effectiveness; no single definitive ICER figure provided
Why PBAC said no
Reasons cited in the latest PSD: inappropriate and ambiguous restriction criteria; trial subjects not representative of target population (trial excluded patients with characteristics where surgery would be inappropriate); methyl aminolevulinate inferior to surgery for complete patient response and lesion recurrence at 36 months; cosmetic outcomes unblinded and subjective; composite outcome (response AND good cosmesis) generated post hoc and not a priori specified; unclear validity of composite outcome; cost-effectiveness presentation in cost/extra month difficult to compare against other health system treatments; cost-utility analysis not conducted despite improved cosmesis being basis of modelled evaluation