Fludarabine PhosphateFludara
Noted HaematologyAuthority RequiredSecond-line line
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.
1
Submissions
1 resub
2008–08
On the record
$15k–45k
ICER range
1 sourced ICER · 2008
ICER stated
Cost basis
Decisions on record
- Meeting Nov 2016 Noted B-cell chronic lymphocytic leukaemia (CLL) no PSD
- Meeting Jul 2008 Recommended Anti-cancer drug no PSD
- Meeting Mar 2008 Recommended Chronic Lymphocytic Leukaemia (CLL).
Access path
- TGA registered · Fludara
TGA label narrower than the PBS population
- Mar 2008Recommended · restricted
vs chlorambucil
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
A stepped economic evaluation was presented which produced an incremental discounted cost per extra discounted quality-adjusted life-year (QALY) gained of between $15,000 and $45,000. PSD · 2008
Decision context
PopulationPatients 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | chlorambucil | $15k–45k | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CLL4 | Ph 3 | — | — | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to combination with cyclophosphamide, advanced disease (Binet B/C) or progressive A, and second-line; TGA label unrestricted by stage, treatment line, or regimen.