CapecitabineCapecitabine-DRLA
adjuvant treatment of stage III (Dukes C) colon cancer, following complete resection of the primary tumour; either as monotherapy or in combination with oxaliplatin
Decisions on record
- Meeting Mar 2011 Recommended Anti–cancer drug
- Meeting Mar 2010 Recommended Cancer treatment
- Meeting Jul 2009 Deferred Anti-cancer drug
- Meeting Nov 2008 Recommended Anti-cancer drug no PSD
Access path
- TGA registered · Capecitabine-DRLA
TGA label narrower than the PBS population
- Nov 2005Recommended · restricted
Comparator changed: Mayo Clinic regimen for 5-FU plus leucovorin → 5-fluorouracil plus…
- Nov 2005Recommended · restricted
Comparator changed: Mayo Clinic regimen for 5-FU plus leucovorin → 5-fluorouracil plus…
- Jul 2009Recommended
Comparator changed: 5-fluorouracil plus leucovorin (Mayo Clinic regimen) → 5-fluorouracil…
- Mar 2010Recommended · restricted
- Mar 2010Recommended · restricted
- Mar 2011Recommended
Comparator changed: 5-fluorouracil (5-FU) → modified FOLFOX-6
- Mar 2011Recommended
Comparator changed: 5-fluorouracil (5-FU) → modified FOLFOX-6
- PBS listing · Authority required
Cost-effectiveness
Cost-minimisation analysis; XELOX associated with cost saving per patient compared to mFOLFOX-6
The PBAC noted that the cost savings are derived through the cost of drug administration, which are MBS item numbers, prostheses costs, and the cost of drug administration in hospitals and that the intervention is not cost-saving to the PBS. PBAC · 2010
Decision context
Populationpatients with stage III (Dukes C) colon cancer, following complete resection of the primary tumour
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2011 | Recommended | modified FOLFOX-6 | — | RCT · OS, PFS, DFS |
| Mar 2011 | Recommended | modified FOLFOX-6 (oxaliplatin with 5-fluorouracil and folinic acid) | — | RCT · OS | PFS | DFS |
| Mar 2010 | Recommended · restricted | 5-fluorouracil (5-FU) | — | RCT |
| Mar 2010 | Recommended · restricted | 5-fluorouracil (5-FU) | — | RCT · OS |
| Jul 2009 | Recommended | 5-fluorouracil (5-FU) | — | RCT · OS, PFS |
| Nov 2005 | Recommended · restricted | Mayo Clinic regimen for 5-FU plus leucovorin | — | RCT · Disease-free survival, Overall survival, Relapse-free survival |
| Nov 2005 | Recommended · restricted | 5-fluorouracil plus leucovorin (Mayo Clinic regimen) | — | RCT · DFS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to monotherapy or oxaliplatin combination; TGA label permits any fluoropyrimidine agent combination.