PBAC's latest decision on Exemestane: Recommended with restriction (2006). Considered for treatment of hormone-dependent early breast cancer in post-menopausal women following a minimum of 2 years treatment with tamoxifen citrate.
PBAC outcome
Recommended with restriction
Restricted benefit
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2006
Submissions
1
2006 → 2006
Eligible population
post-menopausal women with hormone-dependent early breast cancer following a minimum of 2 years treatment with tamoxifen citrate
Therapy area
Oncology
Line of therapy
Later-line
Evidence base
RCT, indirect comparison
Primary endpoint
Disease free survival, Overall survival
Key trials
Study 031, ABCSG trial, ARNO 95 trial
Comparator
tamoxifen
Economic model
CUA, CEA
Risk sharing
Risk-sharing arrangement in place — The PBAC requested that the PBPA negotiate a risk sharing agreement with the sponsor to take into account the potential for usage in adjuvant hormonal treatment of early breast cancer extending beyond 3 years for exemestane (or 5 years in total), for which there is no evidence.