script.reportAU
Haematology

Fludarabine phosphate

Brand: Fludara

PBAC's latest decision on Fludarabine phosphate: Recommended with restriction (2008). Considered for Treatment of B-cell chronic lymphocytic leukaemia (CLL) in combination with cyclophosphamide in patients with advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2008
Submissions
1
2008 → 2008

Eligible population

Patients with B-cell chronic lymphocytic leukaemia with advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease, with CLL diagnosed by lymphocytosis (≥5 × 10⁹ lymphocytes/L) and clonal B-cell population (CD5/CD19) documented by flow cytometry.

Therapy area
Haematology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
583 patients
Key trials
CLL4, Eichhorst et al 2006, Flinn et al 2007
Comparator
chlorambucil
Economic model
CUA
Eligible patients/year
10,000

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