PBAC's latest decision on Ponatinib: Recommended with restriction (2018). Considered for Chronic myeloid leukaemia (CML) in patients with T315I mutation who have failed prior tyrosine kinase inhibitor therapy, or in patients where both nilotinib and dasatinib have failed or where one has failed and the patient is intolerant of the other.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2014
Submissions
4
2014 → 2018
Eligible population
Patients with chronic myeloid leukaemia with T315I mutation who have failed prior imatinib, dasatinib, or nilotinib therapy, or patients where both nilotinib and dasatinib have failed or where one has failed and the patient is intolerant of the other.
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
Other
Economic model
Not modelled
ICER note
Minor submission with no economic evaluation required; changes to existing PBS restrictions only.
Submission history
Nov 2014: Recommended with restriction · Authority Required
Jul 2015: Deferred · Authority Required
Nov 2017: Recommended with restriction · Authority Required
Nov 2018: Recommended with restriction · Authority Required