Relatlimab And NivolumabOpdualag
Treatment of patients with unresectable Stage III or IV malignant melanoma who are PD-1 inhibitor-naive.
Decisions on record
- Meeting Jul 2023 Recommended Melanoma
- Meeting Mar 2023 Recommended Melanoma; unresectable Stage III or IV malignant melanoma
Access path
- TGA registered · Opdualag
TGA label narrower than the PBS population
- Jul 2023Recommended · restricted
vs nivolumab plus ipilimumab (NIVO+IPI)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of relatlimab and nivolumab (RELA+NIVO), a fixed- dose combination treatment, for the treatment of patients with unresectable Stage III or IV malignant melanoma, on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy).PSD · Mar 2023
7.2 The PBAC again considered that the proposed place in therapy for RELA+NIVO, as a first line alternative to currently available PD-1 inhibitor based therapies (i.e. pembrolizumab (PEMBRO), NIVO or NIVO+IPI) was reasonable. 26PSD · Mar 2023
6.40 The resubmission presented a cost-minimisation approach between RELA+NIVO and NIVO+IPI. This was in contrast to the July 2022 submission, which presented a cost- effectiveness analysis between RELA+NIVO and NIVO monotherapy.PSD · Mar 2023
6.41 The equi-effective doses for treatment were calculated based on an unadjusted indirect comparison of treatment utilisation across the CA224047 and the CA209067 trials. Due to the previously identified transitivity issues, it may have been more appropriate to use adjusted results.PSD · Mar 2023
6.37 The resubmission claimed that RELA+NIVO was non-inferior to NIVO+IPI in terms of effectiveness as there were no statistically significant differences between RELA+NIVO and NIVO+IPI in terms of PFS and OS. The ESC considered that this claim was reasonable; however, noted that there were uncertainties relating to the:PSD · Mar 2023
• differences in the follow up periods of the trials, with less mature OS data available from CA224047;PSD · Mar 2023
6.2 The PBAC noted and welcomed the input from two organisations via the Consumer Comments facility on the PBS website. Rare Cancers Australia stated that there remains an unmet need to continue to improve the survival outcomes for patients with metastatic melanoma and that the two checkpoint inhibitors (RELA and NIVO) target distinct immune checkpoint pathways and RELA+NIVO offers the potential for clinically meaningful survival with a manageable safety …PSD · Mar 2023
6.3 The Medical Oncology Group of Australia (MOGA) also expressed its support for the RELA+NIVO submission. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for RELA+NIVO, which was limited to 3 (out of a maximum of 5, where 5 and 4 represent the grades with substantial improvement)5, based on a comparison with nivolumab.PSD · Mar 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationAdults and adolescents aged 12 years or older, weighing at least 40 kg, with unresectable Stage III or IV malignant melanoma, with ECOG performance status 0 or 1, who have not received prior treatment with a PD-1 inhibitor or ipilimumab for this indication.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2023 | Recommended · restricted | nivolumab plus ipilimumab (NIVO+IPI) | — | RCT · PFS |
Consumer voice
Two consumer organisations supported the RELA+NIVO submission for metastatic melanoma. Rare Cancers Australia highlighted unmet need for improved survival outcomes and noted the potential for clinically meaningful survival with manageable safety, while MOGA expressed support and presented an ESMO-MCBS score of 3.
there remains an unmet need to continue to improve the survival outcomes for patients with metastatic melanoma Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to PD-1 inhibitor-naive, first-line treatment, ECOG 0–1, and weight ≥40 kg; TGA label has no such restrictions.