DocetaxelDBL Docetaxel
Treatment of castrate-resistant metastatic prostate cancer; also indicated for other malignancies including breast cancer and non-small cell lung cancer (per existing PBS listings).
Decisions on record
- Meeting Jul 2017 Noted Unrestricted no PSD
- Meeting Jul 2014 Recommended Pharmaceutical Evaluation Branch, Department of Health on behalf of Actavis Pty Ltd, Hospira Pty Ltd, Sandoz Pty Ltd, Sanofi-Aventis Australia Pty Ltd and Sun Pharmaceutical Industries (Australia) Pty Ltd Change to listing (Minor submission) Anti-cancer drug The Department requested the PBAC conside no PSD
- Meeting Jul 2011 Recommended Anti-cancer drug no PSD
- Meeting Mar 2011 Recommended Anti-cancer drug no PSD
- Meeting Mar 2011 Recommended Anti-cancer drug no PSD
- Meeting Mar 2011 Not recommended Anti-cancer drug no PSD
- Meeting Nov 2010 Recommended Anti-cancer drug no PSD
- Meeting Mar 2010 Recommended Cancer treatment no PSD
5 earlier decisions
- Nov 2009 Recommended Anti-cancer drug
- Mar 2009 Not recommended Anti-cancer drug no PSD
- Jul 2008 Recommended Head and neck cancer
- Jul 2007 Recommended Prostate cancer
- Nov 2006 Not recommended Docetaxel is registered by the TGA for the following indications: Prostate cancer: Treatment of patients with androgen independent (hormone refractory) prostate cancer. Breast cancer: Treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Ta
Access path
- TGA registered · DBL Docetaxel
- Jul 2005Recommended
ICER rose $45,000 → $75,000 (+67%)
- Jul 2005Not recommended
uncertain and unacceptable cost-effectiveness, high incremental cost per life year gained ($45,000–$75,000)…
- ↻ resubmittedMar 2006Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Mar 2006Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- Nov 2006Not recommended
Uncertain cost-effectiveness due to highly uncertain utility values in all three analyses; uncertain survival estimates…
- ↻ resubmittedJul 2007Recommended · restricted
ICER dropped $105,000 → $75,000 (-29%)
- Jul 2007Recommended · restricted
ICER dropped $105,000 → $75,000 (-29%)
- Jul 2008Recommended · restricted
Comparator changed: mitoxantrone → cisplatin and fluorouracil (PF)
- Jul 2008Recommended · restricted
Comparator changed: mitoxantrone → cisplatin and fluorouracil (PF)
- Nov 2009Recommended · restricted
Comparator changed: cisplatin and fluorouracil (PF) → doxorubicin plus cyclophosphamide…
- Mar 2017Recommended
Evidence: RCT → Cost-minimisation
- PBS listing · Unrestricted
From the public summary
7.1 The PBAC noted the change to the listings processed by the secretariat. Outcome: RecommendedPSD · Mar 2017
Cost-effectiveness
Minor submission (formulation change only); no new economic evaluation conducted. Cost-neutral to PBS.
The inclusion of this new form of docetaxel is expected to be cost neutral to the PBS. PSD · 2017
Decision context
PopulationAdults with castrate-resistant metastatic prostate cancer; also other malignancies for which docetaxel is indicated on the PBS.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2017 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2009 | Recommended · restricted | doxorubicin plus cyclophosphamide (AC) | $45k–75k | RCT · DFS |
| Jul 2008 | Recommended · restricted | cisplatin and fluorouracil (PF) | — | RCT · OS |
| Jul 2008 | Recommended · restricted | cisplatin and fluorouracil (PF) | — | RCT · OS |
| Jul 2007 | Recommended · restricted | mitoxantrone | $45k–75k | RCT · OS |
| Jul 2007 | Recommended · restricted | mitoxantrone | $45k–75k | RCT · OS |
| Nov 2006 | Not recommended | mitozantrone plus prednisone | $15k–105k | RCT · OS |
| Mar 2006 | Recommended · restricted | FAC (fluorouracil + doxorubicin + cyclophosphamide) | $15k–45k | RCT · OS | DFS |
| Mar 2006 | Recommended · restricted | FAC (fluorouracil + doxorubicin + cyclophosphamide) | $15k–45k | RCT · DFS |
| Jul 2005 | Recommended | FAC (5-fluorouracil, doxorubicin, cyclophosphamide) | $15k–45k | RCT · DFS |
| Jul 2005 | Not recommended | mitoxantrone | $45k–75k | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| TAX316/BCIRG001 | Ph 3 | 1,491 | Number of Participants With Disease-Free Survival Events | completed |