PaclitaxelAbraxane
Recommended OncologyAuthority RequiredFirst-line line
Adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin hydrochloride and cyclophosphamide, irrespective of oestrogen receptor status.
2
Submissions
2006–06
On the record
$15k–45k
ICER range
2 sourced ICERs · 2006
ICER stated
Cost basis
Decisions on record
- Meeting Jul 2014 Recommended Pharmaceutical Evaluation Branch, Department of Health on behalf of Actavis Pty Ltd, Fresenius Kabi Australia Pty Ltd, Hospira Pty Ltd and Sandoz Pty Ltd Change to listing (Minor submission) Anti-cancer drug The Department requested the PBAC consider changing the listings for docetaxel and paclitaxe no PSD
- Meeting Nov 2008 Not recommended Anti-cancer drug no PSD
Access path
- TGA registered · Abraxane
TGA label narrower than the PBS population
- Mar 2006Recommended · restricted
Comparator changed: no sequential therapy following standard chemotherapy with…
- Mar 2006Recommended · restricted
Comparator changed: no sequential therapy following standard chemotherapy with…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
The base case modelled incremental discounted cost per extra discounted quality-adjusted life-years gained for all node-positive patients was in the range of $15,000 - $45,000 for both scenario 1 and scenario 2. PSD · 2006
ICER uncertainEconomic model disputed
Decision context
PopulationNode-positive breast cancer patients irrespective of oestrogen receptor status, receiving adjuvant chemotherapy sequentially to doxorubicin and cyclophosphamide.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2006 | Recommended · restricted | no sequential therapy following standard chemotherapy with doxorubicin hydrochloride and cyclophosphamide (AC) | $15k–45k | RCT · Disease-free survival, Overall survival |
| Mar 2006 | Recommended · restricted | no sequential therapy following standard chemotherapy with doxorubicin hydrochloride and cyclophosphamide (AC) alone | $15k–45k | RCT · DFS |
Similar precedents
Paclitaxel, Nanoparticle Albumin-Bound78%Nab-Paclitaxel74%Docetaxel73%Trastuzumab Emtansine68%Paclitaxel-Nanoparticle Albumin Bound69%Pertuzumab67%Exemestane67%Neratinib67%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to node-positive early breast cancer post-surgery; TGA label includes broader adjuvant use without node-positivity requirement.