PBAC's latest decision on Nilotinib: Recommended (2011). Considered for First-line treatment of chronic phase Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML-CP).
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2008
Submissions
2
2008 → 2011
Eligible population
Adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
MMR
Pivotal trial size
845 patients
Key trials
ENESTnd, DASISION
Comparator
imatinib 400 mg once daily
Economic model
Cost-minimisation
Budget impact
$-10000000
ICER note
Cost-minimisation analysis performed; no ICER calculated as no statistically significant difference in overall survival demonstrated between nilotinib and imatinib
Submission history
Mar 2008: Recommended with restriction · Authority Required