BendamustineBendamustine Juno
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.
Decisions on record
- Meeting Jul 2015 Recommended Non-Hodgkin's lymphoma
- Meeting Mar 2015 Deferred Non-Hodgkin’s Lymphoma and Mantle Cell Lymphoma
Access path
- TGA registered · Bendamustine Juno
TGA label narrower than the PBS population
- Mar 2015Deferred
vs R-CHOP (rituximab, cyclophosphamide, doxorubicin…
- Jul 2015Recommended · restricted
Comparator changed: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of bendamustine for the treatment of indolent non-Hodgkins Lymphoma and Mantle Cell Lymphoma.PSD · Jul 2015
7.2 The PBAC considered that bendamustine presented a less toxic alternative to existing treatments for NHL and MCL and accepted that it improved progression free survival.PSD · Jul 2015
- Justify the use of a 20 year time horizon for indolent NHL” .PSD · Jul 2015
Financial estimates Rituximab maintenance therapy not included Sensitivity analysis: R-CHOP + in the economic model. rituximab maintenance.PSD · Jul 2015
6.11 The March 2015 submission claimed that bendamustine plus rituximab was superior in terms of effectiveness and safety compared with R-CHOP for the first-line treatment of iNHL and MCL in patients who meet certain criteria. The re-submission did not seek to change the clinical claim presented in the original submission and accepted by PBAC.PSD · Jul 2015
6.2 The PBAC noted and welcomed the input from individuals (2), health care professionals (2) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with bendamustine, including improved quality of life and survival, in addition to a reduction in adverse events compared with alternative, more toxic, treatments.PSD · Jul 2015
Cost-effectiveness
ICER values are redacted (marked as '****') in the pricing table; no numeric ICER stated in the public text
Decision context
PopulationPreviously 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended · restricted | R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone) | — | RCT · PFS |
| Mar 2015 | Deferred | R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) for previously untreated patients; best suppo | — | RCT · PFS |
Consumer voice
Consumer input from individuals, healthcare professionals, and organisations described benefits of bendamustine treatment, including improved quality of life and survival, with reduced adverse events compared to alternative treatments.
The comments described a range of benefits of treatment with bendamustine, including improved quality of life and survival, in addition to a reduction in adverse events compared with alternative, more toxic, treatments. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts MCL to patients ineligible for stem cell transplantation; TGA label applies this restriction to both NHL and MCL.