FedratinibInrebic
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.
Decisions on record
- Meeting May 2026 Recommended Myelofibrosis no PSD
- Meeting Nov 2025 Recommended Intermediate/high-risk primary myelofibrosis and post-PV/ET myelofibrosis
- Meeting May 2025 Not recommended Intermediate-2/high-risk myelofibrosis post-ruxolitinib
Access path
- TGA registered · Inrebic
TGA label narrower than the PBS population
- May 2025Not recommended
vs best available therapy (suboptimal ruxolitinib treatment…
- ↻ resubmittedNov 2025Recommended
Comparator changed: best available therapy (suboptimal ruxolitinib treatment…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the PBS listing of fedratinib for the treatment of 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 …PSD · Nov 2025
7.2 The PBAC maintained its view that there is a clinical place for fedratinib as an alternative or additional treatment option to or after ruxolitinib (and to a lesser extent momelotinib). The PBAC reiterated its view that there was a moderate need for a new JAK inhibitor in this disease area and noted the evidence suggested fedratinib could be effective in patients who had lost response to ruxolitinib over time.PSD · Nov 2025
6.51 The resubmission applied a cost-minimisation approach (CMA) to calculating the proposed effective price for fedratinib compared to ruxolitinib for patients with intermediate-1, intermediate-2 or high risk myelofibrosis across all lines of therapy (see Table 11).PSD · Nov 2025
Table 11: Key components and assumptions of the cost-minimisation approach Component Claim or assumption Based on evidence presented in Section 2, efficacy is assumed to be at least non- Therapeutic claim: effectiveness inferior Therapeutic claim: safety Based on evidence presented in Section 2, safety is assumed to be non-inferior Indirect treatment comparison of fedratinib and ruxolitinib in the first line treatment setting (intermediate-2 and high risk …PSD · Nov 2025
6.43 In consideration of the totality of evidence presented for fedratinib in the May 2025 submission and the current resubmission, the resubmission described fedratinib as non-inferior in terms of efficacy and safety compared to ruxolitinib.PSD · Nov 2025
6.44 The claim of non-inferior efficacy presented in the submission was adequately supported by the evidence presented in the resubmission. However, the following issues should be considered:PSD · Nov 2025
6.2 The PBAC noted and welcomed the input from individuals (8), health care professionals (2) and organisations (3) via the Consumer Comments facility on the PBS website. The PBAC noted the comments from individuals described the impact of myelofibrosis on their quality of life, including the heavy mental burden associated with the disease and the uncertain future it creates.PSD · May 2025
6.3 The Leukaemia Foundation stated ruxolitinib is the current standard of care for the treatment of myelofibrosis. The input noted that ruxolitinib has shown efficacy in reducing spleen volume and increase 5-year overall survival rates. However, the prognosis for patients that stop responding to ruxolitinib is poor and due to limited treatment options, patient with relapsed or refractory disease often remain on suboptimal ruxolitinib therapy.PSD · May 2025
Cost-effectiveness
Cost-minimisation approach applied; no ICER calculated by design. Effective price redacted (shown as '$$$$').
Decision context
PopulationAdult 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).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | ruxolitinib | — | RCT · Surrogate |
| May 2025 | Not recommended | best available therapy (suboptimal ruxolitinib treatment, hydroxyurea, peginterferon alfa-2a, busulfan, or prednisone) | — | RCT · Spleen volume; myelofibrosis-associated symptoms |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| FREEDOM-2 | Ph 3 | 38 | Percentage of Participants Who Have a ≥ 35% Spleen Volume Reduction (SVR) at End of Cycle … | terminated |
Consumer voice
Consumer input from 8 individuals, 2 healthcare professionals, and 3 organisations described the significant impact of myelofibrosis on quality of life, including mental burden and limited treatment options. Health professionals noted fedratinib's potential advantage as an alternative to ruxolitinib, while patient organisations emphasized the need for additional treatment options to prevent clinic
The comments from individuals described the impact of myelofibrosis on their quality of life, including the heavy mental burden associated with the disease and the uncertain future it creates. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to intermediate-2/high-risk or intermediate-1 with severe symptoms; TGA label includes all disease-related splenomegaly/symptoms regardless of risk stratification.