LetrozoleARX-LETROZOLE
Treatment of hormone-dependent advanced and early breast cancer in post-menopausal women; extended adjuvant treatment of hormone-dependent early breast cancer in post-menopausal women commencing within 6 months of ceasing treatment with tamoxifen citrate.
Decisions on record
- Meeting Nov 2014 Recommended The Medical Oncology Group of Australia on behalf of various sponsors Change to listing (Correspondence) Cancer The Medical Oncology Group of Australia sought to have the drugs anastrozole, everolimus, exemestane, goserelin and letrozole made available to males with breast cancer
- Meeting Jul 2008 Not recommended Breast cancer no PSD
- Meeting Mar 2007 Recommended Anti cancer drug
- Meeting Nov 2006 Recommended Breast cancer no PSD
- Meeting Mar 2002 Recommended Breast cancer no PSD
Access path
- TGA registered · ARX-LETROZOLE
TGA label narrower than the PBS population
- Nov 2005Not recommended
unacceptably high cost-effectiveness ratio, immature survival data (median follow-up 2.4 years with early unblinding)…
- Nov 2005Not recommended
Unacceptably high cost-effectiveness ratio, immature overall survival data (no significant OS benefit at 2.4-year…
- ↻ resubmittedJul 2006Recommended · restricted
ICER dropped $75,000 → $55,000 (-27%)
- Mar 2007Recommended · restricted
ICER dropped $55,000 → $35,000 (-36%)
- PBS listing · Restricted
Cost-effectiveness
Base case modelled incremental discounted cost per discounted QALY. Alternative analysis for distant metastases only was in the range $40,000 to $45,000, but PBAC did not accept this submission's cost per QALY associated with distant metastases alone.
However, even the base-case modelled incremental discounted cost per extra discounted extra QALY gained was considered unacceptably high. PBAC · 2005
Decision context
PopulationPost-menopausal women with hormone receptor positive breast cancer who have received standard adjuvant therapy with tamoxifen citrate
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2007 | Recommended · restricted | placebo (no extension of hormonal intervention) | $30k–35k | RCT · OS, PFS |
| Jul 2006 | Recommended · restricted | anastrozole | $15k–55k | RCT · DFS |
| Nov 2005 | Not recommended | placebo | $45k–75k | RCT · DFS |
| Nov 2005 | Not recommended | placebo | $45k–75k | RCT · DFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to early breast cancer setting; TGA label does not specify disease stage or treatment line.