AvelumabBavencio
Maintenance treatment of locally advanced (Stage III) or metastatic (Stage IV) urothelial carcinoma in patients whose disease has not progressed following first-line platinum-based chemotherapy.
Decisions on record
- Meeting Jul 2024 Noted Stage IV clear cell variant renal cell carcinoma no PSD
- Meeting Jul 2024 Noted Stage IV metastatic Merkel cell carcinoma no PSD
- Meeting Mar 2023 Noted Stage IV clear cell variant renal cell carcinoma no PSD
- Meeting Mar 2022 Noted Urothelial carcinoma
- Meeting Mar 2021 Recommended Maintenance treatment of Stage III or IV urothelial carcinoma
- Meeting Mar 2021 Recommended First-line Stage IV clear cell RCC, intermediate or poor IMDC risk
- Meeting Mar 2020 Not recommended Renal cell carcinoma (RCC)
- Meeting Jul 2018 Recommended Metastatic merkel cell carcinoma (MCC)
Access path
- TGA registered · Bavencio
TGA label narrower than the PBS population
- Jul 2018Recommended
vs chemotherapy regimens (cyclophosphamide + doxorubicin +…
- Mar 2020Not recommended
Comparator changed: chemotherapy regimens (cyclophosphamide + doxorubicin + vincristine…
- ↻ resubmittedMar 2021Recommended
- Mar 2021Recommended · restricted
- Mar 2022Recommended · restricted
Comparator changed: best supportive care + subsequent pembrolizumab → best supportive care
- PBS listing · Authority Required
From the public summary
5.1 The PBAC advised that avelumab, for the maintenance treatment of locally advanced or metastatic urothelial carcinoma, would be acceptably cost-effective at the price proposed by the sponsor with a risk sharing arrangement incorporating expenditure caps based on a mean avelumab treatment duration of months in order to achieve cost-effectiveness.PSD · Mar 2022
5.2 The PBAC noted that the sponsor had made most of its suggested changes to the economic model including applying: a 7.5 year time horizon; the exponential function to extrapolate time to treatment discontinuation; and the effective price of pembrolizumab. The PBAC noted that using these parameters and the vial price proposed by the sponsor ($ per vial), the ICER would $95,000 to < $115,000/QALY.PSD · Mar 2022
4.1 The sponsor submitted an economic model that incorporated the following changes that were consistent with the previous Public Summary Document: • a 7.5-year time horizonPSD · Mar 2022
• use of the exponential function to extrapolate time to treatment discontinuation for the avelumab + BSC arm (which resulted in a mean treatment duration of 12.64 months without the financial stopping rule) • the effective price of pembrolizumabPSD · Mar 2022
non-inferior safety profile compared with nivolumab + ipilimumab.PSD · Mar 2021
Source: Table 1.1-2, p17 of the previous submission; Table 1, Avelumab Public Summary Document, March 2020 PBAC meeting.PSD · Mar 2021
6.2 The Medical Oncology Group of Australia (MOGA) expressed its support for the avelumab + axitinib submission. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO- MCBS) for avelumab + axitinib, which was limited to 3 (out of a maximum of 5, where 5 and 4 represent the grades with substantial improvement)1, based on an indirect comparison with nivolumab + ipilimumab.PSD · Mar 2021
The PBAC noted and welcomed the input from health care professionals (1) and organisations (3) via the Consumer Comments facility on the PBS website. The comments from BEAT Bladder Cancer Australia and Rare Cancers Australia highlighted the negative impact on quality of life associated with this condition as a result of symptoms such as pain, weight loss and frailty.PSD · Mar 2021
Cost-effectiveness
ICER range with financial stopping rule and revised price; without the stopping rule, ICER would be $95,000 to <$115,000/QALY
The sponsor proposed reducing the avelumab price (from $ to $) and an month financial stopping rule. This resulted in an ICER of $55,000 to < $75,000 per QALY (using the model submitted by the sponsor). PSD · 2022
Decision context
PopulationPatients with locally advanced (Stage III) or metastatic (Stage IV) urothelial carcinoma with WHO performance status 0 or 1 whose disease has not progressed following first-line platinum-based chemotherapy
Risk sharingSponsor agreed to join existing Risk Sharing Arrangement for second-line pembrolizumab with revised expenditure caps to address uncertainties regarding uptake rates and treatment duration costs
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | best supportive care | $55k–75k | RCT · OS |
| Mar 2021 | Recommended | nivolumab in combination with ipilimumab | — | RCT · OS |
| Mar 2021 | Recommended · restricted | best supportive care + subsequent pembrolizumab | — | RCT · OS |
| Mar 2020 | Not recommended | nivolumab in combination with ipilimumab | — | RCT · PFS |
| Jul 2018 | Recommended | chemotherapy regimens (cyclophosphamide + doxorubicin + vincristine, carboplatin + etoposide, or cisplatin + etoposide) | — | RCT · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| JAVELIN Merkel 200 | Ph 2 | 204 | Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response … | completed |
| JAVELIN Renal 101 | Ph 3 | 886 | Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) i… | completed |
| JAVELIN Bladder 100 | Ph 3 | 700 | Overall Survival (OS) | completed |
Consumer voice
Consumer and professional organisations highlighted the significant negative impact on quality of life from bladder cancer symptoms (pain, weight loss, frailty) and expressed support for avelumab as an active treatment approach that could extend survival. The Medical Oncology Group of Australia categorised avelumab as a highest-priority therapy for PBS listing.
The comments from BEAT Bladder Cancer Australia and Rare Cancers Australia highlighted the negative impact on quality of life associated with this condition as a result of symptoms such as pain, weight loss and frailty. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status 0–1 and excludes prior PD-1/PD-L1 inhibitor treatment; TGA label has no such restrictions.