Temsirolimus
Not recommended OncologyPrivate hospital authority requiredLater-line line
treatment of advanced renal cell carcinoma (RCC) in patients with a poor prognosis who meet certain criteria
1
Submissions
2008–08
On the record
$100k
ICER range
1 sourced ICER · 2008
ICER stated
Cost basis
Decision on record
- Meeting Jul 2008 Not recommended Kidney cancer
Access path
- Jul 2008Recommended
vs best supportive care
- PBS listing · Private hospital authority required
RecommendedDeferredNot recommended
Cost-effectiveness
ICER stated as '>$100,000 per QALY' — lower bound captured as 100000; upper bound not specified
Decision context
Populationadult patients with histologically or cytologically confirmed advanced renal cell carcinoma, who have at least three of the following six factors predictive of poor prognosis
Why it was knocked back
- uncertain evidence of clinical effectiveness due to indirect comparison with lack of exchangeability across trials, unacceptably high and uncertain incremental cost-effectiveness ratio (>$100,000 per QALY), uncertainty about magnitude of treatment effect of temsirolimus versus BSC, different quality of life assessment instruments across trials with inadequate data on QoL non-inferiority, greater frequency of adverse events in temsirolimus group, uncertainty regarding effect on QoL, challenges in estimating mean survival benefit
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2008 | Recommended | best supportive care | $100k | RCT | Other (indirect comparison and meta-analysis) · OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to poor prognosis patients meeting ≥3 of 6 criteria and later-line therapy; TGA label has no such restrictions.