Relatlimab With NivolumabOpdualag
Treatment of patients with unresectable Stage III or IV malignant melanoma who have not previously received systemic anti-cancer therapy for this indication.
Decision on record
- Meeting Jul 2022 Not recommended Unresectable Stage III or IV malignant melanoma
Access path
- TGA registered · Opdualag
TGA label narrower than the PBS population
- Jul 2022Not recommended
vs nivolumab monotherapy
From the public summary
7.1 The PBAC did not recommend the listing of relatlimab with nivolumab (RELA+NIVO) fixed dose combination product for the treatment of patients with unresectable Stage III or IV malignant melanoma. The PBAC considered that there is a low clinical need for RELA+NIVO as there are existing effective treatment options available on the PBS (programmed cell death protein 1 (PD-1) monotherapy (nivolumab and pembrolizumab) and combination therapy (nivolumab plus …PSD · Jul 2022
The PBAC considered that the nominated primary comparator of nivolumab 34PSD · Jul 2022
6.57 The submission presented a cost-utility analysis (CUA) of RELA+NIVO compared to nivolumab monotherapy based on the results of the direct randomised trial, CA224047. Key components of the economic evaluation are presented in Table 10.PSD · Jul 2022
6.58 The ESC noted that the submission did not present an economic evaluation of RELA+NIVO compared with NIVO+IPI, based on the claim of non-inferior efficacy.PSD · Jul 2022
The submission described RELA+NIVO as superior in terms of effectiveness and inferior in terms of safety compared to nivolumab monotherapy. The ESC considered that nivolumab monotherapy was not the appropriate primary comparator.PSD · Jul 2022
The ESC and PBAC considered that the efficacy claim was supported; however, the magnitude of the treatment effect was uncertain as:PSD · Jul 2022
The PBAC noted and welcomed the input from individuals (6), health care professionals (1) and organisations (3) via the Consumer Comments facility on the PBS website. The comments from individuals, the Melanoma and Skin Cancer Advocacy Network (MSCAN) and Melanoma Patients Australia supported the submission and highlighted the demand for alternate effective therapies.PSD · Jul 2022
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)6, based on a comparison with nivolumab.PSD · Jul 2022
Cost-effectiveness
ICER value not stated in the provided text excerpt; economic analysis details appear to be redacted or incomplete in the supplied document portion.
Decision context
PopulationAdults and adolescents 12 years of age or older, weighing at least 40 kg, with unresectable Stage III or IV malignant melanoma, previously untreated with systemic anti-cancer therapy, with ECOG performance status 0 or 1, excluding uveal melanoma.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2022 | Not recommended | nivolumab monotherapy | — | RCT · PFS |
Consumer voice
Individuals, patient advocacy organisations (MSCAN and Melanoma Patients Australia), and the Medical Oncology Group of Australia expressed support for the RELA + NIVO submission, highlighting demand for alternate effective therapies. MOGA presented an ESMO-MCBS score of 3 for RELA + NIVO based on comparison with nivolumab.
The comments from individuals, the Melanoma and Skin Cancer Advocacy Network (MSCAN) and Melanoma Patients Australia supported the submission and highlighted the demand for alternate effective therapies. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naive patients with Stage III/IV disease and ECOG 0–1, excluding uveal melanoma; TGA label permits all unresectable/metastatic melanoma regardless of prior therapy.