ExemestaneAPO-EXEMESTANE
Sequential adjuvant treatment of hormone-dependent early breast cancer in post-menopausal women following a minimum of 2 years treatment with tamoxifen citrate.
Decisions on record
- Meeting Nov 2014 Recommended Indication not stated
- Meeting Nov 2006 Recommended Breast cancer no PSD
Access path
- TGA registered · APO-EXEMESTANE
TGA label narrower than the PBS population
- Jul 2006Recommended · restricted
Evidence: RCT, indirect comparison → RCT
- Jul 2006Recommended · restricted
Evidence: RCT, indirect comparison → RCT
- PBS listing · Restricted
Cost-effectiveness
The modelled cost-effectiveness ratios presented in the submission were considered acceptable by the Committee. PBAC · 2006
Decision context
PopulationPost-menopausal women with hormone-dependent early breast cancer who have received at least 2 years of prior adjuvant tamoxifen therapy.
Risk sharingPBAC 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2006 | Recommended · restricted | tamoxifen | $15k–45k | RCT, indirect comparison · Disease free survival, Overall survival |
| Jul 2006 | Recommended · restricted | tamoxifen | $15k–45k | RCT · DFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to minimum 2 years prior tamoxifen; TGA label requires only prior tamoxifen without duration specified.