PBAC's latest decision on Fedratinib: Recommended with restriction (2025). Considered for Treatment of patients with intermediate-2/high-risk primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis who are JAK inhibitor naïve or post-JAK inhibitor therapy; and intermediate-1 risk myelofibrosis patients with severe disease-related symptoms resistant, refractory or intolerant to available therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Adult patients with intermediate-2 or high risk primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis who are JAK inhibitor naïve or post ruxolitinib or another JAK inhibitor; and intermediate-1 risk myelofibrosis patients with severe disease-related symptoms that are resistant, refractory or intolerant to available therapy (second line treatment).
Therapy area
Haematology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
JAKARTA, COMFORT-I, COMFORT-II, FREEDOM-2
Comparator
ruxolitinib
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach applied; no ICER calculated by design. Effective price redacted (shown as '$$$$').
Submission history
May 2025: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required