NilotinibTasigna
First-line treatment of chronic phase Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML-CP)
Decisions on record
- Meeting Nov 2012 Recommended Leukaemia no PSD
- Meeting Nov 2011 Recommended Anti-cancer drug no PSD
- Meeting Jul 2011 Recommended Chronic myeloid leukaemia
- Meeting Jul 2008 Recommended Chronic myeloid leukaemia (CML) no PSD
- Meeting Mar 2008 Recommended Chronic Myeloid Leukaemia (CML)
Access path
- TGA registered · Tasigna
TGA label narrower than the PBS population
- Mar 2008Recommended · restricted
vs dasatinib 70 mg twice daily and high-dose imatinib (600 to…
- Jul 2011Recommended
Comparator changed: dasatinib 70 mg twice daily and high-dose imatinib (600 to 800 mg per…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated as no statistically significant difference in overall survival demonstrated between nilotinib and imatinib
The PBAC noted that the costs of monitoring liver function tests and electrocardiogram monitoring, (which is recommended prior to commencement of treatment with nilotinib and after seven days of treatment), were not included in the cost-minimisation analysis. The PBAC considered that these costs should be included. PBAC · 2011
Decision context
PopulationAdults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2011 | Recommended | imatinib 400 mg once daily | — | RCT · MMR |
| Mar 2008 | Recommended · restricted | dasatinib 70 mg twice daily and high-dose imatinib (600 to 800 mg per day) | — | Single-arm · ORR |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use after imatinib/dasatinib failure; TGA label permits use after any prior therapy including imatinib.