Paclitaxel, Nanoparticle Albumin-Bound
A 250 mg strength of nanoparticle albumin-bound paclitaxel for Stage IV (metastatic) adenocarcinoma of the pancreas in combination with gemcitabine, metastatic breast cancer, and HER2 positive breast cancer.
Decisions on record
- Meeting Nov 2021 Withdrawn Adenocarcinoma of the pancreas and breast cancer no PSD
- Meeting Mar 2019 Recommended Adenocarcinoma of the pancreas Breast cancer
- Meeting Mar 2014 Recommended Abraxane® Specialised Therapeutics Australia Pty Ltd Pancreatic cancer To request Section 100 [Efficient Funding of Chemotherapy (Public and Private)] Authority Required (STREAMLINED) listing for the treatment, in combination with gemcitabine, of patients with locally advanced, unresectable or metas
Access path
- Dec 2008Not recommended
Initial rejection: uncertain clinical benefits (no significant overall survival benefit vs. paclitaxel in target…
- ↻ resubmittedMar 2019Recommended
Evidence: RCT → Other
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the listing of a 250 mg vial of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) powder for injection under the same conditions as the currently listed nab-paclitaxel 100 mg vial. The PBAC did not recommend a price increase for nab-paclitaxel use in pancreatic cancer.PSD · Mar 2019
5.2 The PBAC recommended the 250 mg vial at an equivalent price per mg to the existing 100 mg vial for its corresponding indications. The PBAC noted that since there should be no increase in patient numbers or the cost for each patient, the 250 mg vial listing should not increase overall cost to the Government.PSD · Mar 2019
Cost-effectiveness
Minor submission with no economic analysis presented. However, the PBAC recalled that at its March 2014 meeting, the base case ICER for the 100 mg vial was $45,000 to $75,000/LYS.
The incremental cost per life year saved for the ITT population was between $45,000 and $75,000. PSD · 2008
Decision context
PopulationPatients with Stage IV (metastatic) adenocarcinoma of the pancreas, metastatic breast cancer, or HER2 positive breast cancer, with ECOG performance status score of 2 or less, with no prior PBS-subsidised therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended | — | — | Other |
| Dec 2008 | Not recommended | paclitaxel (solvent-based) | $45k–75k | RCT · ORR |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line, ECOG ≤2, no prior PBS therapy, and adds HER2-positive breast cancer specificity.