Methyl AminolevulinateMetvix
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.
Access path
- TGA registered · Metvix
TGA label narrower than the PBS population
- 2005Not recommended
inappropriate and ambiguous restriction criteria; trial subjects not representative of target population (trial…
- Nov 2005Not recommended
inappropriate and ambiguous restriction that could allow majority of BCC patients as first-line therapy, trial…
Cost-effectiveness
The trial-based and modelled economic evaluations both reported an incremental discounted cost of <$15,000. The exact value is not stated; the presented figure is an upper bound estimate.
The trial-based incremental discounted cost/extra discounted patient with complete response and good to excellent cosmetic outcome at 36 months was <$15,000. PSD · 2005
Decision context
PopulationPatients aged 18 years or older with primary superficial or nodular basal cell carcinoma where surgery is inappropriate due to risk of post-surgical morbidities or disfigurement, with lesions confirmed histologically or by specialist opinion.
Why it was knocked back
- inappropriate and ambiguous restriction that could allow majority of BCC patients as first-line therapy, trial population not representative of those for whom listing was sought (excluded patients with characteristics where surgery would be inappropriate), methyl aminolevulinate inferior to surgery on primary outcome (patient complete response and lesion recurrence), uncertain and inadequately demonstrated cost-effectiveness, composite outcome (complete response AND excellent/good cosmesis) not a priori specified and given inappropriate equal weighting, unblinded subjective assessment of cosmetic outcomes, absence of quality of life data preventing cost-utility analysis
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Not recommended | surgical excision | $15k | RCT |
| 2005 | Not recommended | surgical excision | — | RCT · patient complete response and lesion recurrence |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to BCC only and specifies surgery inappropriate due to morbidity/disfigurement risk; TGA label includes actinic keratoses and broader BCC indications.