August 2013 PBAC Outcomes - Positive Recommendations

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Positive recommendations from the August 2013 PBAC Special meeting

Drug and Form

Drug use and type

Listing requested by sponsor

PBAC Recommendation


12.5mg, 25mg and 50mg capsules



Pancreatic cancer

Extension of Section 85 Authority Required listing to include  initial and continuing treatment of metastatic, unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (or carcinoma) (pancreatic NET) in patients who are symptomatic (despite somatostatin analogues) or who have documented disease progression.


The PBAC recommended listing sunitinib malate as a Section 85 Authority Required listing for unresectable, well-differentiated pancreatic neuroendocrine tumour (pNET) in patients who meet certain criteria.


The PBAC considered that in the context of high clinical need, the lack of alternative treatments, the rarity of pNET, the small number of patients predicted and the relatively modest overall financial impact on the PBS, sunitinib was acceptably cost effective for pNET.