July 2009 PBAC Outcomes - Deferrals

DRUG AND FORM	DRUG USE AND TYPE	LISTING REQUESTED BY SPONSOR	PBAC OUTCOME AND COMMENT
AZACITIDINE, powder for injection, 100 mg, Vidaza®  Celgene Pty Ltd Major submission	Myelodysplastic syndrome Chronic myelomonocytic leukaemia Acute myeloid leukaemia	Section 100 listing for the treatment of myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML) in patients who meet certain criteria.	The PBAC deferred its consideration of azacitidine to allow further analysis of the economic model, and to recalculate costs on the basis of inclusion in Section 85 of the Schedule of Pharmaceutical Benefits with costs on a per vial basis.
		Sponsor’s comments:	Celgene will continue to work with the PBAC to clarify the issues outstanding and work towards a positive recommendation.
CAPECITABINE, tablets, 150 mg and 500 mg, Xeloda®   Roche Products Pty Ltd   Major submission	Anti-cancer drug	Extend the current Authority required listing to include the treatment of previously untreated advanced oseophago-gastric cancer, in combination with a platinum based regimen.	The PBAC deferred its consideration of capecitabine so that the issues regarding the cost of the Diagnosis Related Groups and magnitude of the cost-offsets can be resolved.
		Sponsor’s comments:	The sponsor needs to clarify the decision with the PBAC.