Nab-Paclitaxel
Treatment of HER2-positive metastatic breast cancer in combination with trastuzumab.
Decisions on record
- Meeting Nov 2015 Not recommended Breast cancer
- Meeting Dec 2008 Recommended Breast cancer no PSD
From the public summary
7.1 The PBAC rejected the request for PBS subsidy of the use of nab-paclitaxel in combination with trastuzumab, in the treatment of patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer.PSD · Nov 2015
7.2 In making this recommendation, the PBAC recalled its decision on a resubmission for pertuzumab, trastuzumab and trastuzumab emtansine considered at the November 2014 PBAC meeting. At the time, the PBAC recommended that “nab- paclitaxel should be excluded from use with pertuzumab + trastuzumab by the pertuzumab restriction” (Public Summary Document - November 2014 PBAC Meeting Items 7.5 & 7.8).PSD · Nov 2015
6.11 The November 2008 submission claimed that nab-paclitaxel offers numerous clinical advantages (i.e. superior response rates, progression-free survival, overall survival, reduced adverse events, and greater convenience in administration) over solvent- based paclitaxel (Minutes, December 2008 PBAC Meeting).PSD · Nov 2015
6.12 At the November 2008 PBAC meeting, the nab-paclitaxel ‘formulation was noted to have potential advantages over solvent-based paclitaxel which included: no cremophor EL or ethanol in the formulation which reduced hypersensitivity reactions, no requirement for premedications, a shorter infusion time, and the possibility of using standard drip sets’ (Minutes, November 2008 PBAC meeting).PSD · Nov 2015
6.2 The PBAC noted and welcomed the input from health care professionals (3) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with nab-paclitaxel including the ease of administration and better tolerability to the currently available alternatives.PSD · Nov 2015
Cost-effectiveness
This was a minor submission (price reduction only); no ICER was modelled. The submission was cost-minimisation in nature, not an economic evaluation with ICER.
The PBAC reaffirmed that there was no basis for the cost of nab-paclitaxel to be greater than that of either solvent-based paclitaxel or docetaxel because the resubmission did not present any clear evidence for improved efficacy of nab-paclitaxel used in combination with trastuzumab over either of the comparators. PBAC · 2015
Decision context
PopulationPatients with HER2-positive metastatic breast cancer receiving trastuzumab (later lines of therapy).
Why it was knocked back
- no clear evidence for improved efficacy of nab-paclitaxel over solvent-based paclitaxel or docetaxel; no basis to justify the cost premium over comparators; cost of nab-paclitaxel more than 30 times that of solvent-based paclitaxel
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Not recommended | solvent-based paclitaxel and docetaxel | — | Single-arm · ORR |
Consumer voice
Healthcare professionals and organizations provided input supporting nab-paclitaxel treatment, highlighting ease of administration and better tolerability compared to alternatives, and requesting clarification on clinical practice use and supporting relisting in combination with trastuzumab.
the comments described a range of benefits of treatment with nab-paclitaxel including the ease of administration and better tolerability to the currently available alternatives Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HER2-positive patients in later-line therapy with trastuzumab; TGA label includes all anthracycline-failed metastatic breast cancer regardless of HER2 status or line.