Methyl 5-Aminolevulinate Hydrochloride
Treatment of superficial basal cell carcinoma (sBCC) in patients who cannot have surgical excision, cryotherapy, or curettage with diathermy.
Access path
- Jul 2007Not recommended
uncertain comparative effectiveness (small non-randomised trial with wide confidence intervals), uncertain…
- Jul 2007Not recommended
uncertain comparative effectiveness due to low numbers and wide confidence intervals in pivotal trial, uncertain…
- ↻ resubmittedMar 2008Recommended
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated as the analysis was cost-minimisation rather than cost-utility or cost-effectiveness.
Given the uncertainty over the clinical comparison, the cost-minimisation approach was not considered to be justified. PBAC · 2007
Decision context
PopulationAdult patients with biopsy-confirmed primary superficial basal cell carcinoma for whom surgical excision, cryotherapy, or curettage with diathermy are inappropriate.
Why it was knocked back
- uncertain comparative effectiveness, lack of scientific rigour in the evidentiary base, higher recurrence rates with MAL-PDT compared to imiquimod at 2 and 5 years, problems with the cost-minimisation analysis including uncertainty about appropriate number of imiquimod sachets and inappropriate exclusion of non-government costs
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended | imiquimod | — | RCT |
| Jul 2007 | Not recommended | imiquimod | — | RCT | Single-arm · null |
| Jul 2007 | Not recommended | imiquimod | — | RCT · CR |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to superficial BCC only, excluding nodular BCC present in the TGA label.