script.reportAU
Haematology

Decitabine + cedazuridine

Brand: Inqovi

PBAC's latest decision on Decitabine + cedazuridine: Deferred (2021). Considered for Treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukaemia (CMML) in high-risk patients.

PBAC outcome
Deferred
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2021
Submissions
1
2021 → 2021

Eligible population

Adult patients with myelodysplastic syndrome classified as intermediate-2 or high-risk according to IPSS with ≤30% marrow blasts, and chronic myelomonocytic leukaemia patients with 10% to 29% marrow blasts without myeloproliferative disorder.

Therapy area
Haematology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
133 patients
Key trials
ASCERTAIN, ASTX727-01-B, Kantarjian 2006, Lubbert 2011, Fenaux 2009, Silverman 2002
Comparator
azacitidine
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Economic evaluation presented but not detailed in the public summary.

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