July 2007 PBAC Outcomes - Subsequent Decision to Defer

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Drug and Form Drug Use and Type Listing Requested by Sponsor PBAC Outcome and Comment
DOCETAXEL, vial, 20 mg, 80 mg, Taxotere®

sanofi-aventis Australia Pty Ltd
Major submission
Prostate cancer Authority required for treatment of androgen independent (hormone refractory) prostate cancer. The PBAC noted that no new efficacy and safety data had been presented, but that a new Australian Utility study had been conducted to elicit utility weights for a new Q-TWiST analysis. Although there were some residual concerns with the Q-TWiST analysis, the PBAC concluded that it was unlikely that further adjustments would alter substantially the resultant incremental cost-effectiveness ratio (ICER). 

Nevertheless, the PBAC considered that the ICER was unacceptably high. The Committee indicated that, if the sponsor were to offer a price reduction, it would be prepared to consider the matter again out-of-session. 

The PBAC indicated that any restriction on the listing of docetaxel should stipulate use as first-line chemotherapy, a minimum Karnofsky score of 60%, that dosing must be on a 3-weekly basis (there was no survival difference when weekly dosing was used) and a maximum of 10 cycles. 

(See also positive recommendations from July 2007)
Sponsor’s comments The sponsor is considering the PBAC proposal