Brentuximab VedotinAdcetris
First-line treatment of adult patients with previously untreated CD30+ advanced (stage III or IV) Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (A+AVD).
Decisions on record
- Meeting Jul 2025 Recommended First-line advanced Hodgkin lymphoma in combination with chemotherapy
- Meeting Mar 2024 Not recommended Hodgkin lymphoma
- Meeting Mar 2021 Recommended First-line CD30+ peripheral T-cell lymphoma
- Meeting Nov 2018 Recommended Cutaneous T-cell lymphomas (CTCL)
- Meeting Jul 2018 Not recommended Refractory or relapsed CD30 positive cutaneous T-cell lymphomas (CTCL)
- Meeting Dec 2017 Recommended CD30 positive systemic anaplastic large cell lymphoma (sALCL) no PSD
- Meeting Nov 2016 Recommended Hodgkin lymphoma
- Meeting Nov 2016 Recommended Hodgkin lymphoma
3 earlier decisions
- Mar 2015 Not recommended Hodgkin Lymphoma
- Jul 2014 Recommended 50 mg injection, 1 x 50 mg vial Adcetris® Takeda Pharmaceuticals Australia Pty Ltd New listing (Major submission) Systemic anaplastic large cell lymphoma (sALCL) To propose a re-specified economic model following the March 2014 PBAC recommendation to list brentuximab for the treatment of adult patie
- Mar 2014 Recommended Adcetris® Takeda Pharmaceutical Australia Pty Ltd Systemic Anaplastic Large Cell Lymphoma (sALCL) To request a Section 100 (Efficient Funding of Chemotherapy) Authority Required (+/- STREAMLINED) listing for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell l
Access path
- TGA registered · Adcetris
TGA label narrower than the PBS population
- Mar 2014Recommended · restricted
vs multi-agent salvage chemotherapy (ICE, DHAP, ESHAP)
- Jul 2014Recommended · restricted
Comparator changed: multi-agent salvage chemotherapy (ICE, DHAP, ESHAP) → multi-agent…
- Mar 2015Not recommended
Comparator changed: multi-agent salvage chemotherapy → salvage chemotherapy…
- ↻ resubmittedNov 2016Recommended · restricted
Comparator changed: salvage chemotherapy (gemcitabine+vinorelbine) → salvage chemotherapy…
- Nov 2016Recommended · restricted
Comparator changed: salvage chemotherapy (gemcitabine+vinorelbine) → salvage chemotherapy…
- Jul 2018Not recommended
Comparator changed: Salvage chemotherapy (gemcitabine + vinorelbine, single chemotherapy…
- ↻ resubmittedNov 2018Recommended · restricted
Comparator changed: vorinostat (primary); methotrexate (supplementary) → vorinostat…
- Mar 2021Recommended · restricted
Comparator changed: vorinostat, methotrexate → CHOP (cyclophosphamide, doxorubicin…
- Mar 2024Not recommended
Comparator changed: CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) →…
- ↻ resubmittedJul 2025Recommended · restricted
Comparator changed: PET-adapted ABVD (doxorubicin, bleomycin, vincristine and…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Section 100 Efficient Funding of Chemotherapy, Authority Required (Telephone/Online) listing of brentuximab vedotin in combination with doxorubicin, vinblastine and dacarbazine (A+AVD) for the first-line treatment of advanced Hodgkin lymphoma.PSD · Jul 2025
7.2 The PBAC noted the input from health care professionals, Rare Cancers Australia, Leukaemia Foundation, Lymphoma Australia and the Australasian Leukaemia and Lymphoma group supporting the listing. The comments highlighted the need for 41 OFFICIALPSD · Jul 2025
The submission presented a cost-utility analysis of A+AVD The resubmission argued that the ABVD arm in the versus PET-adapted ABVD based on the ECHELON-1 trial ECHELON-1 trial is a reasonable proxy for PET-adapted of A+AVD versus non-PET-adapted ABVD.PSD · Jul 2025
The resubmission also presented additional supportive evidence based on a more recent data cut from the RATHL trial and a conference abstract/poster (Kristo 2023) that presented results of two unanchored matching adjusted indirect comparisons (MAICs) of A+AVD and PET-adapted ABVD.PSD · Jul 2025
6.49 The resubmission described A+AVD as superior in terms of efficacy compared to PET- adapted ABVD (using non-PET-adapted ABVD as a proxy). The PBAC previously 22 OFFICIALPSD · Jul 2025
OFFICIAL Public Summary Document - July 2025 PBAC meeting considered that the claim of superior efficacy for A+AVD compared to PET-adapted ABVD (with options to escalate/de-escalate treatment) was highly uncertain based on the supportive evidence presented and high level of censoring in the key trial, but likely to be reasonable (para 7.8, brentuximab vedotin PSD, March 2024 PBAC meeting).PSD · Jul 2025
6.2 The PBAC noted and welcomed the input from health care professionals (5) and organisations (4) via the Consumer Comments facility on the PBS website. The input from health care professionals described current treatment regimens with ABVD or BEACOPP as reasonably effective but noted they were associated with significant risks of short and longer term toxicity.PSD · Jul 2025
6.3 The PBAC noted the advice received from three consumer organisations. Input from Rare Cancers Australia described the impact of Hodgkin lymphoma on patients quality of life and the toxicity of the current treatment options available.PSD · Jul 2025
Cost-effectiveness
ICER value not stated in the public text; the document indicates the economic model was revised to a Markov structure but the numeric ICER is not published.
The PBAC considered that continuing use of brentuximab vedotin would not be cost-effective in the absence of an objective response given the economic evaluation presented the results as a cost per responder and the potential toxicity with continuing treatment. PBAC · 2018
Decision context
PopulationAdult patients with previously untreated CD30+ advanced (stage III or IV) Hodgkin lymphoma, treated with brentuximab vedotin in combination with doxorubicin, vinblastine and dacarbazine (A+AVD) for 6 × 28-day cycles.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | PET-adapted ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) | — | RCT · PFS |
| Mar 2024 | Not recommended | PET-adapted ABVD (doxorubicin, bleomycin, vincristine and dacarbazine) | — | RCT · PFS |
| Mar 2021 | Recommended · restricted | CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) | $25k–35k | RCT · OS |
| Nov 2018 | Recommended · restricted | vorinostat, methotrexate | — | RCT · ORR |
| Jul 2018 | Not recommended | vorinostat (primary); methotrexate (supplementary) | — | RCT · ORR |
| Nov 2016 | Recommended · restricted | salvage chemotherapy (gemcitabine-based regimens) | — | Single-arm · ORR |
| Nov 2016 | Recommended · restricted | Salvage chemotherapy (gemcitabine + vinorelbine, single chemotherapy agents, and anti-tumour steroid regimens) and best | $45k–75k | Single-arm · PFS |
| Mar 2015 | Not recommended | salvage chemotherapy (gemcitabine+vinorelbine) | — | Single-arm · OS |
| Jul 2014 | Recommended · restricted | multi-agent salvage chemotherapy | $45k–75k | RCT · Other |
| Mar 2014 | Recommended · restricted | multi-agent salvage chemotherapy (ICE, DHAP, ESHAP) | $45k–75k | Single-arm · OS |
Consumer voice
Health care professionals and consumer organisations highlighted the significant short and long-term toxicities associated with current Hodgkin lymphoma treatments (ABVD/BEACOPP), emphasizing the importance of treatment options with lower toxicity profiles, particularly regarding fertility and cardiac/pulmonary complications, and noting that brentuximab vedotin may offer reduced relapse risk and l
Input highlighted that A+AVD is associated with relatively high rates of peripheral neuropathy and increased rates of infection but noted that the side effects experienced are often manageable through dosing guidelines and the use of growth factor support. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC specifies stage III or IV disease and limits to 6 cycles; TGA label does not stage-restrict or cycle-limit.