Nivolumab And Ipilimumab
First-line treatment of patients with unresectable malignant pleural mesothelioma.
Decisions on record
- Meeting May 2025 Recommended Neoadjuvant therapy for Stage III melanoma no PSD
- Meeting Jul 2024 Not recommended Unresectable malignant mesothelioma
Access path
- Jul 2018Recommended · restricted
vs nivolumab monotherapy
- Mar 2021Recommended · restricted
Comparator changed: nivolumab monotherapy → pemetrexed-based chemotherapy (pemetrexed…
- Jul 2024Not recommended
Comparator changed: pemetrexed-based chemotherapy (pemetrexed plus cisplatin or…
From the public summary
5.1 The PBAC did not advise making amendments to the current Risk Sharing Arrangement (RSA) for nivolumab (Opdivo®) and ipilimumab (Yervoy®) for unresectable malignant mesothelioma. The PBAC advised that the evidence provided by the submission did not sufficiently justify the requested changes to the subsidisation caps or rebate for expenditure above the caps.PSD · Jul 2024
5.2 The submission presented potential causes of an increase in uptake rates and thus expenditure. These included increased initiation with NIVO+IPI as a result of changes to international treatment guidelines and an absence of competitor clinical trials. The PBAC considered that no evidence was provided to support that changes to guidelines had increased uptake of NIVO+IPI.PSD · Jul 2024
The submission presented a partitioned survival analysis model with three health states: alive without progression (PFS), alive following progression (PD), and dead.PSD · Mar 2021
The economic evaluation presented a cost-utility analysis, with cost per life years (LY) gained also presented. A summary of the model is presented below.PSD · Mar 2021
First-line setting The submission described NIVO+IPI as superior in terms of effectiveness compared to pemetrexed-based chemotherapy. The ESC considered the therapeutic conclusion presented in the submission in regard to the comparative effectiveness of NIVO+IPI versus pemetrexed-based chemotherapy was supported by the evidence presented The submission described NIVO+IPI as non-inferior in terms of safety compared to pemetrexed-based chemotherapy, with a …PSD · Mar 2021
The PBAC considered that the claim of superior comparative effectiveness was reasonable in the first line setting.PSD · Mar 2021
4.2 The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The comments from the Lung Foundation of Australia supported continued PBS-listing of NIVO+IPI for unresectable malignant 3PSD · Jul 2024
• An increased uptake rate for first-line (1L) mesothelioma patients.PSD · Jul 2024
Cost-effectiveness
This is a Category 3 submission requesting revision of utilisation estimates and risk-sharing arrangement caps for an already-listed medicine. No new economic evaluation or ICER was presented.
Decision context
PopulationPatients with unresectable malignant pleural mesothelioma eligible for first-line treatment (ECOG 0-1 performance status).
Risk sharingRisk Sharing Arrangement (RSA) with expenditure caps. The sponsor requested either an increase to the existing RSA caps to reflect higher-than-estimated utilisation or a reduction in the rebate percentage payable above the caps. The PBAC did not advise making amendments to the current RSA.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Not recommended | best supportive care | — | Cost-minimisation |
| Mar 2021 | Recommended · restricted | pemetrexed-based chemotherapy (pemetrexed plus cisplatin or pemetrexed plus carboplatin) in first-line setting; best sup | — | RCT · OS |
| Jul 2018 | Recommended · restricted | nivolumab monotherapy | — | RCT · OS |
Consumer voice
The Lung Foundation of Australia supported continued PBS-listing of NIVO+IPI for unresectable malignant mesothelioma, highlighting access to a variety of treatments, clinical benefits compared to other treatments, and that NIVO+IPI is an effective treatment which improves patient outcomes.
The comments from the Lung Foundation of Australia supported continued PBS-listing of NIVO+IPI for unresectable malignant mesothelioma. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ECOG 0-1 performance status; TGA label does not specify performance status eligibility criteria.