Sunitinib MalateARX-SUNITINIB
Initial and continuing treatment of metastatic, unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pancreatic NET) in patients who are symptomatic despite somatostatin analogues or have documented disease progression.
Decisions on record
- Meeting Mar 2015 Recommended Pancreatic neuroendocrine tumours Stage IV clear cell renal cell carcinoma Gastrointestinal stromal tumours no PSD
- Meeting Jul 2009 Recommended Anti-cancer drug
- Meeting Mar 2008 Not recommended Anti Cancer drug
- Meeting Mar 2008 Not recommended Anti Cancer drug
- Meeting Mar 2007 Deferred Anti cancer drug
- Meeting Mar 2007 Deferred Anti cancer drug
Access path
- TGA registered · ARX-SUNITINIB
TGA label narrower than the PBS population
- Mar 2007Deferred
Comparator changed: best supportive care (BSC) → imatinib mesylate
- Mar 2007Recommended
Comparator changed: best supportive care (BSC) → imatinib mesylate
- Mar 2007Deferred
Comparator changed: best supportive care (BSC) → imatinib mesylate
- Mar 2007Recommended
Comparator changed: best supportive care (BSC) → imatinib mesylate
- Mar 2008Not recommended
unacceptably high and uncertain ICER, uncertainty mainly due to impact of continued sunitinib post-progression, base…
- Mar 2008Not recommended
unacceptably high and uncertain cost effectiveness (ICER $75,000–$105,000 per QALY gained), uncertain survival gain…
- ↻ resubmittedJul 2008Recommended · restricted
ICER dropped $105,000 → $75,000 (-29%)
- Jul 2009Recommended · restricted
Comparator changed: best supportive care → best supportive care (placebo)
- Jul 2011Not recommended
high and uncertain incremental cost-effectiveness ratio, uncertainty in overall survival benefit due to early trial…
- Mar 2012Deferred
Comparator changed: best supportive care → best supportive care (placebo)
- Mar 2012Deferred
Comparator changed: best supportive care → best supportive care (placebo)
Cost-effectiveness
The PBAC noted that multivariate analyses conducted during the evaluation using differential utility weights for pre- and post-progression (0.73 and 0.596, respectively), and assuming a tapered treatment effect, demonstrated that the ICER could be substantially greater than the base case (in the range of between $75,000 and 105,000/QALY compared to the base case ICER of between $45,000 and 75,000/QALY). PBAC · 2012
Decision context
PopulationAdults with metastatic, unresectable, well-differentiated malignant pancreatic neuroendocrine tumour who are symptomatic despite somatostatin analogues or have documented disease progression.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2012 | Deferred | best supportive care (placebo) | $45k–75k | RCT · PFS, OS |
| Mar 2012 | Deferred | best supportive care (placebo) | $45k–75k | RCT · PFS |
| Jul 2011 | Not recommended | best supportive care | $45k–75k | RCT · PFS | OS |
| Jul 2009 | Recommended · restricted | best supportive care (placebo) | $45k–75k | RCT · TTP, OS |
| Jul 2008 | Recommended · restricted | best supportive care | $45k–75k | RCT · PFS |
| Mar 2008 | Not recommended | best supportive care (placebo) | $75k–200k | RCT · PFS |
| Mar 2008 | Not recommended | best supportive care (BSC) without hormonal support / placebo | $75k–105k | RCT · PFS |
| Mar 2007 | Deferred | best supportive care (BSC) | $75k–105k | RCT · PFS, OS |
| Mar 2007 | Recommended | imatinib mesylate | — | RCT | Other (indirect comparison) · OS, PFS |
| Mar 2007 | Deferred | best supportive care (BSC) | $75k–105k | RCT · PFS |
| Mar 2007 | Recommended | imatinib mesylate | — | RCT · TTP |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line RCC with ECOG 0-1; TGA label includes advanced RCC without performance status or line-of-therapy restrictions.