PBAC's latest decision on Temsirolimus: Not recommended (2008). Considered for treatment of advanced renal cell carcinoma (RCC) in patients with a poor prognosis who meet certain criteria.
PBAC outcome
Not recommended
Private hospital authority required
ICER (AUD/QALY)
$100k/QALY
Base-case
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
adult patients with histologically or cytologically confirmed advanced renal cell carcinoma, who have at least three of the following six factors predictive of poor prognosis
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT | Other (indirect comparison and meta-analysis)
Primary endpoint
OS
Key trials
Trial TEM 304, Trial MRC RCC 2000
Comparator
best supportive care
Economic model
CUA
ICER note
ICER stated as '>$100,000 per QALY' — lower bound captured as 100000; upper bound not specified
Why PBAC said no
Reasons cited in the latest PSD: 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