PBAC's latest decision on Sorafenib tosylate: Not recommended (2008). Considered for Initial and continuing treatment of advanced renal cell carcinoma in patients with WHO performance status 2 or less, with continuing treatment defined as disease not experiencing progression.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
$75k/QALY
Range: $45k/QALY–$75k/QALY
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
Patients with advanced (unresectable or metastatic) renal cell carcinoma with WHO performance status 2 or less.
Therapy area
Oncology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS
Key trials
Trial 11213, Trial 11848
Comparator
placebo/best supportive care
Economic model
CUA
Eligible patients/year
10,000
Why PBAC said no
Reasons cited in the latest PSD: unacceptably high and uncertain cost-effectiveness ratio, high clinical uncertainty associated with claimed survival advantage, uncertain place in treatment algorithm, overall survival analysis did not reach statistical significance, first-line evidence lacking (Trial 11848 showed no benefit), cross-over contamination in pivotal trial