BevacizumabAbevmy
Metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced/metastatic/recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian/fallopian tube/primary peritoneal cancer, recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer, and cervical cancer.
Decisions on record
- Meeting Mar 2025 Noted Various cancers no PSD
- Meeting Mar 2024 Recommended Cancers
- Meeting Jul 2022 Noted Metastatic colorectal cancer, advanced or metastatic non-squamous non-small cell lung cancer, relapsed or recurrent glioblastoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, cervical cancer no PSD
- Meeting Mar 2022 Recommended Cancers
- Meeting Nov 2021 Recommended Glioblastoma; Hepatocellular carcinoma; Non-small cell lung cancer; Epithelial ovarian/fallopian tube/peritoneal cancer; Colorectal cancer
- Meeting Mar 2021 Recommended Non-small cell lung cancer
- Meeting Nov 2020 Recommended Metastatic colorectal cancer (mCRC); advanced stage IIIB, IIIC or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; advanced carcinoma of the cervix; stage IV (metastatic) non-small cell lung cancer (NSCLC); relapsed or recurrent glioblastoma
- Meeting Jul 2020 Recommended Advanced International Federation of Gynecology and Obstetrics Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer Advanced carcinoma of cervix Relapsed or recurrent glioblastoma Stage IV (metastatic) non-small cell lung cancer Metastatic colorectal cancer
10 earlier decisions
- May 2019 Recommended Relapsed or refractory glioblastoma.
- Mar 2019 Deferred Glioblastoma
- Mar 2016 Recommended Advanced cervical cancer
- Nov 2015 Not recommended Advanced cervical cancer
- Mar 2014 Not recommended Avastin® Roche Products Pty Limited Indicated in the treatment of: - metastatic colorectal cancer - locally recurrent or metastatic breast cancer - unresectable advanced, metastatic or recurrent, non-squamous non-small cell lung cancer - advanced and/or metastatic renal cell carcinoma - grade IV gli
- Nov 2013 Recommended 100 mg/4 mL and 400 mg/16 mL, injection, vial Avastin® Roche Products Pty Limited Major submission Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer Section 100 (Efficient Funding of Chemotherapy) Authority Required listing for the treatment, in combination with paclitaxel and
- Mar 2011 Not recommended Anti–cancer drug
- Nov 2010 Not recommended Anti-cancer drug
- Jul 2008 Recommended Colorectal cancer
- Mar 2008 Not recommended Colo-rectal cancer
Access path
- TGA registered · Abevmy
TGA label equal than the PBS population
- Mar 2008Not recommended
unacceptably high cost-effectiveness ratio in first-line setting, unacceptably high and uncertain cost-effectiveness…
- ↻ resubmittedJul 2008Recommended · restricted
ICER dropped $200,000 → $75,000 (-62%)
- Nov 2010Not recommended
uncertain clinical benefit, unacceptably high ICER, non-comparable trial populations with significant patient…
- Mar 2011Not recommended
unacceptably high and uncertain cost-effectiveness ratio, marginal overall survival gain of 2 months, greater than…
- ↻ resubmittedNov 2013Recommended · restricted
Comparator changed: carboplatin and paclitaxel → carboplatin and paclitaxel (doublet…
- Mar 2014Not recommended
re-modelling approaches overestimated incremental overall survival gain and incremental QALYs gained; rejected…
- Nov 2015Not recommended
Comparator changed: doublet chemotherapy alone (carboplatin plus paclitaxel) →…
- ↻ resubmittedMar 2016Recommended · restricted
- Mar 2019Deferred
Comparator changed: chemotherapy alone (platinum-based chemotherapy plus paclitaxel or…
- May 2019Recommended · restricted
Comparator changed: best supportive care, salvage chemotherapy (e.g. lomustine…
- Jul 2020Recommended · restricted
Comparator changed: lomustine (salvage chemotherapy) → Avastin (reference brand…
- Nov 2020Recommended · restricted
Evidence: RCT → Single-arm
- Mar 2021Recommended · restricted
Evidence: Single-arm → Cost-minimisation
- Nov 2021Recommended · restricted
Comparator changed: Avastin (reference brand bevacizumab) → Mvasi (bevacizumab biosimilar)
- Mar 2022Recommended · restricted
Comparator changed: Mvasi (bevacizumab biosimilar) → Mvasi (bevacizumab biosimilar) and…
- Mar 2024Recommended · restricted
Comparator changed: Mvasi (bevacizumab biosimilar) and Avastin (originator bevacizumab) →…
- PBS listing · Unrestricted
From the public summary
6.1 The PBAC recommended the Section 100 EFC, Unrestricted Benefit listing of a new biosimilar brand of bevacizumab (Vegzelma) in the forms: solution for I.V. infusion 100 mg in 4 mL; and solution for I.V. infusion 400 mg in 16 mL, under the same circumstances as the PBS-listed biosimilar brands of bevacizumab (Abevmy, Bevaciptin, Mvasi).PSD · Mar 2024
6.2 The PBAC considered that the nomination of Avastin (the reference brand of bevacizumab) as comparator was appropriate, however, noted that the other biosimilar brands of bevacizumab could also be considered as appropriatePSD · Mar 2024
5.9 The submission presented a cost-minimisation analysis of Vegzelma compared with Avastin based on the clinical evidence demonstrating biosimilarity between Vegzelma and Avastin. The equi-effective doses were estimated as 1 mg Vegzelma and 1 mg Avastin (and the other PBS-listed brands of bevacizumab).PSD · Mar 2024
5.10 The submission stated that the proposed listing would not result in additional costs associated with ongoing patient management and monitoring, co-administered treatments, and other related costs.PSD · Mar 2024
5.6 The submission noted that the TGA found Vegzelma to be biosimilar to Avastin and that the TGA Delegate considered that Vegzelma had comparable pharmacokinetics, efficacy, safety, and immunogenicity to Avastin.PSD · Mar 2024
5.7 The submission therefore claimed the non-inferior comparative effectiveness and non-inferior comparative safety of Vegzelma compared with Avastin and other bevacizumab biosimilars by extension.PSD · Mar 2024
5.2 The PBAC noted and welcomed the input from individuals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the benefits of having additional treatment options such as Vegzelma on the PBS including flexibility in treatment and potential affordability.PSD · Mar 2024
5.3 The PBAC noted that the Medical Oncology Group of Australia (MOGA) strongly supported the listing of Vegzelma. Clinical trailsPSD · Mar 2024
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated by design
The PBAC considered that it was appropriate for Vegzelma to be cost-minimised to the existing PBS-listed brands of bevacizumab. PBAC · 2024
Decision context
PopulationPatients with metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced/metastatic/recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian/fallopian tube/primary peritoneal cancer, recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer, and cervical cancer.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | Avastin (reference brand bevacizumab); other PBS-listed bevacizumab biosimilars (Abevmy, Bevaciptin, Mvasi) | — | RCT · Surrogate |
| Mar 2022 | Recommended · restricted | Mvasi (bevacizumab biosimilar) and Avastin (originator bevacizumab) | — | RCT · ORR |
| Nov 2021 | Recommended · restricted | Mvasi (bevacizumab biosimilar) | — | RCT · Biosimilarity |
| Mar 2021 | Recommended · restricted | Avastin (reference brand bevacizumab) | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | Avastin (reference brand bevacizumab) | — | Single-arm · Other |
| Jul 2020 | Recommended · restricted | Avastin (reference brand bevacizumab) | — | RCT · Biosimilarity |
| May 2019 | Recommended · restricted | lomustine (salvage chemotherapy) | — | RCT · PFS |
| Mar 2019 | Deferred | best supportive care, salvage chemotherapy (e.g. lomustine, carboplatin) | — | RCT · PFS |
| Mar 2016 | Recommended · restricted | chemotherapy alone (platinum-based chemotherapy plus paclitaxel or topotecan plus paclitaxel) | $45k–75k | RCT · OS |
| Nov 2015 | Not recommended | chemotherapy alone (platinum-based chemotherapy plus paclitaxel or topotecan plus paclitaxel) | — | RCT · OS |
| Mar 2014 | Not recommended | doublet chemotherapy alone (carboplatin plus paclitaxel) | $75k–105k | RCT · PFS |
| Nov 2013 | Recommended · restricted | carboplatin and paclitaxel (doublet chemotherapy) | — | RCT · PFS |
| Mar 2011 | Not recommended | carboplatin and paclitaxel | $200k | RCT · OS, PFS |
| Nov 2010 | Not recommended | temozolomide, best supportive care and salvage chemotherapy | $75k–105k | Single-arm |
| Jul 2008 | Recommended · restricted | Reported in the March 2008 PBAC Public Summary Document. | $45k–75k | RCT · Other |
| Mar 2008 | Not recommended | placebo (standard medical management); FOLFOX noted as the clinically appropriate comparator in first-line use | $105k–200k | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| GOG-0218 | Ph 3 | 1,873 | Progression-free Survival | completed |
| NCT03247673 | Ph 1 | 141 | AUC0-inf | completed |
| NCT03676192 | Ph 3 | 689 | Objective Response Rate (ORR) During the Induction Study Period From Central Review | completed |
Consumer voice
Consumer input from 1 individual and 2 organisations, including strong support from the Medical Oncology Group of Australia, highlighted benefits of additional treatment options such as Vegzelma on the PBS including flexibility in treatment and potential affordability.
The comments described the benefits of having additional treatment options such as Vegzelma on the PBS including flexibility in treatment and potential affordability. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC indication lists identical cancer types and stages as the TGA-registered label with no additional restrictions or narrowing applied.