Liposomal Daunorubicin And Cytarabine
Treatment of newly diagnosed therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC) in patients without prior chemotherapy induction and without FLT3-ITD/TKD mutations or favourable cytogenetic risk.
Access path
- Apr 2024Recommended · restricted
- PBS listing · Authority Required
From the public summary
4.1 The PBAC recommended liposomal daunorubicin and cytarabine (Vyxeos) be listed on the Section 100 HSD Program as an interim listing, while system and administrative issues relating to a Section 100 EFC listing are being resolved.PSD · Apr 2024
4.2 The PBAC noted that, under Section 100 EFC, patients are not required to pay a co- payment for the supply of a repeat prescription but would be required to do so under Section 100 HSD. The PBAC acknowledged the additional financial burden this may place on patients, however the availability of liposomal daunorubicin and cytarabine on Section 100 HSD provides for subsidised access that would not be available if a Section 100 HSD listing was not …PSD · Apr 2024
Cost-effectiveness
Not modelled; this is an interim administrative listing on Section 100 HSD while system and IT issues for EFC listing are resolved. No economic evaluation conducted.
Decision context
PopulationAdults with newly diagnosed therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC), without prior chemotherapy induction, without FLT3-ITD/TKD mutations, without favourable cytogenetic risk, and with WHO performance status ≤2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Apr 2024 | Recommended · restricted | — | — | Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients without FLT3-ITD/TKD mutations, without favourable cytogenetic risk, and with WHO performance status ≤2; TGA label has no such restrictions.