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 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 |
