July 2007 PBAC Outcomes - Subsequent Decision to Defer
|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
|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|