Sorafenib TosylateNEXAVAR
Initial and continuing treatment of advanced hepatocellular carcinoma in patients with unresectable disease, specifically BCLC Stage C HCC with WHO performance status ≤2 and Child Pugh class A.
Decision on record
- Meeting Mar 2008 Not recommended Sorafenib tosylate is indicated for the treatment of patients with advanced renal cell carcinoma
Access path
- TGA registered · NEXAVAR
TGA label narrower than the PBS population
- Nov 2006Recommended
vs placebo for best supportive care
- Mar 2008Not recommended
unacceptably high and uncertain cost-effectiveness ratio, high clinical uncertainty associated with claimed survival…
- ↻ resubmittedJul 2008Recommended · restricted
Listing: Not applicable → Authority Required
- PBS listing · Authority Required
Cost-effectiveness
The Committee considered that the submission's base case incremental cost-effectiveness ratio of sorafenib over placebo in the range of $45,000 - $75,000 per life year gained was reasonable, which when quality adjusted would result in a ratio per quality-adjusted life-years gained more than $75,000. PBAC · 2008
Decision context
PopulationPatients with advanced (BCLC Stage C) hepatocellular carcinoma with WHO performance status 2 or less and Child Pugh class A, where curative treatment options have been exhausted and surgery or loco-regional therapy is not appropriate or has failed.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2008 | Recommended · restricted | placebo/best supportive care | $45k–75k | RCT · OS |
| Mar 2008 | Not recommended | placebo/best supportive care | $45k–75k | RCT · OS |
| Nov 2006 | Recommended | placebo for best supportive care | $45k–75k | RCT · PFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status 2 or less and first-line treatment; TGA label has no performance status or line-of-therapy restrictions.