March 2010 PBAC Outcomes - Deferrals

 

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DRUG AND FORM DRUG USE AND TYPE LISTING REQUESTED BY SPONSOR PBAC OUTCOME AND COMMENT
Rituximab, solution for IV infusion, 100 mg in 10 mL, 500 mg in 50 mL, Mabthera®

Roche Products Pty Ltd

Major submission
Monoclonal antibody for use in leukaemia Authority required listing under Section 85 and a Section 100 listing under the Chemotherapy Pharmaceutical Access Program (CPAP) for the treatment of CD20 positive, chronic lymphocytic leukaemia, in combination with chemotherapy. The PBAC deferred the submission to request the sponsor recalculate the incremental cost-effectiveness in the modelled economic evaluation to include consideration of the uncertainties identified by the PBAC.
Sponsor's comments: The sponsor had no comment.