PBAC's latest decision on Bendamustine: Recommended with restriction (2015). Considered for First-line treatment of previously untreated Stage III-IV indolent CD20-positive non-Hodgkin's lymphoma (iNHL) and Stage III-IV mantle cell lymphoma (MCL) in combination with rituximab.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2015
Submissions
2
2015 → 2015
Eligible population
Previously untreated adults with Stage III-IV indolent CD20-positive non-Hodgkin's lymphoma or Stage III-IV mantle cell lymphoma, for whom bendamustine is given in combination with rituximab as induction treatment only (maximum 6 cycles/12 doses). For MCL, patients must be ineligible for stem cell transplantation.
Therapy area
Haematology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
514 patients
Key trials
StiL
Comparator
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone)
Economic model
CUA
ICER note
ICER values are redacted (marked as '****') in the pricing table; no numeric ICER stated in the public text
Submission history
Mar 2015: Recommended with restriction · Authority Required
Jul 2015: Recommended with restriction · Restricted