SunitinibSunitinib Sandoz
Initial and continuing treatment of metastatic, unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) in patients who are symptomatic despite somatostatin analogues or who have documented disease progression.
Decisions on record
- Meeting Jul 2012 Not recommended Treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET). Sunitinib is also registered for the treatment of advanced renal cell carcinoma and for the treatment of gastrointestinal stromal tumour after failure of imatinib mesylate treatment due to resistance o
- Meeting Mar 2012 Deferred Anti-cancer drug
- Meeting Jul 2011 Not recommended Anti-cancer drug
Access path
- TGA registered · Sunitinib Sandoz
TGA label narrower than the PBS population
- Jul 2012Recommended
vs best supportive care (placebo)
- Aug 2013Recommended
Comparator changed: best supportive care (placebo) → best supportive care/placebo
- PBS listing · Authority Required
Cost-effectiveness
The PBAC noted the value of the ICER for pNET was between the accepted ICERs for the RCC and GIST indications and considered that the proposed ICER for pNET was closer to that of RCC than for GIST. PBAC · 2013
Decision context
PopulationAdults with metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) who are symptomatic despite somatostatin analogues or have documented disease progression.
Risk sharingThe sponsor offered to renegotiate the current risk share arrangement to include sunitinib for pNET.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Aug 2013 | Recommended | best supportive care/placebo | $45k–75k | RCT · OS |
| Jul 2012 | Recommended | best supportive care (placebo) | $45k–75k | RCT · PFS, OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to metastatic disease, symptomatic despite somatostatin analogues, or documented progression; TGA label includes all unresectable pancreatic NETs.