CemiplimabLIBTAYO
First-line treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations, in combination with platinum doublet chemotherapy, irrespective of histology or PD-L1 expression levels.
Decisions on record
- Meeting Nov 2023 Recommended Stage IV (metastatic) non-small cell lung cancer (first-line with platinum doublet chemotherapy)
- Meeting Jul 2022 Withdrawn Cervical cancer, recurrent or metastatic with disease progression on or after chemotherapy no PSD
- Meeting Mar 2022 Recommended Squamous cell carcinoma
- Meeting Nov 2021 Recommended Non-small cell lung cancer (NSCLC)
- Meeting Nov 2021 Deferred Squamous cell carcinoma (SCC)
- Meeting Nov 2020 Not recommended Squamous cell carcinoma (SCC)
Access path
- TGA registered · LIBTAYO
TGA label narrower than the PBS population
- Nov 2020Not recommended
vs best supportive care (BSC) with or without chemotherapy (CT)
- ↻ resubmittedNov 2021Recommended · restricted
Comparator changed: best supportive care (BSC) with or without chemotherapy (CT) →…
- Mar 2022Recommended · restricted
Comparator changed: pembrolizumab monotherapy → best supportive care with or without…
- Nov 2023Recommended · restricted
Comparator changed: best supportive care with or without chemotherapy → pembrolizumab in…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100 (Efficient Funding of Chemotherapy) Authority Required (Streamlined) listing of cemiplimab to be used with platinum doublet chemotherapy (PDC) as a first-line treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC) with no evidence of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ROS-proto-oncogene 1 (ROS1) aberrations.PSD · Nov 2023
The PBAC did not consider there to be an unmet clinical need for cemiplimab, as there are currently multiple PBS listed immunotherapies to treat patients with stage IV NSCLC. However, the PBAC noted the consumer comments regarding the benefit of having an alternative treatment option available to patients.PSD · Nov 2023
The submission presented a cost-minimisation approach (CMA) based on the indirect comparison between cemiplimab+PDC to pembrolizumab+PDC using placebo+PDC as the common reference for patients with Stage IV NSCLC.PSD · Nov 2023
The equi-effective doses were estimated as cemiplimab 350 mg Q3W administered as an IV infusion over 30 minutes plus PDC administered as an IV infusion and pembrolizumab 200 mg Q3W administered as an IV infusion over 30 minutes plus PDC administered as an IV infusion, assuming the same treatment durations and dose intensities.PSD · Nov 2023
The submission described cemiplimab+PDC as non-inferior in terms of effectiveness compared to pembrolizumab+PDC. The evaluation considered the claim was adequately supported by evidence, but the following issues need to be considered:PSD · Nov 2023
• The effectiveness of cemiplimab+PDC in patients with PD-L1<1% remained uncertain due to a lower median OS reported in the cemiplimab+PDC arm (12.8 months) compared to the placebo+PDC arm (14.2 months) in the primary analysis of Study 16113, with a HR of 1.006 (95% CI: 0.63, 1.60). The results from the final analyses also did not support the claim of superior efficacy in patients with PD- L1<1%, with a HR for OS of 0.94 (95% CI: 0.62, 1.42).PSD · Nov 2023
The PBAC noted and welcomed the input from Lung Foundation Australia via the Consumer Comments facility on the PBS website. Lung Foundation Australia described the potential benefits of the listing of cemiplimab on the PBS including providing patients with an additional treatment choice.PSD · Nov 2023
The submission stated that the sponsor is amenable to joining the current risk sharing arrangements applying to PD-L1 inhibitors for the treatment of NSCLC. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2023
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The submission presented a cost-minimisation approach (CMA) based on the indirect comparison between cemiplimab+PDC to pembrolizumab+PDC using placebo+PDC as the common reference for patients with Stage IV NSCLC. PSD · 2023
Decision context
PopulationAdult patients with Stage IV (metastatic) NSCLC without EGFR, ALK, or ROS1 aberrations, who have not previously received systemic therapy for advanced NSCLC, with WHO performance status 0 or 1
Risk sharingSpecial Pricing Arrangement (SPA) applies
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | pembrolizumab in combination with platinum doublet chemotherapy | — | Meta-analysis · OS |
| Mar 2022 | Recommended · restricted | best supportive care with or without chemotherapy | — | Single-arm · ORR |
| Nov 2021 | Recommended · restricted | pembrolizumab monotherapy | — | RCT · OS |
| Nov 2020 | Not recommended | best supportive care (BSC) with or without chemotherapy (CT) | — | Single-arm · ORR |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| PD-L1 testing for metastatic non-small cell lung cancer | programmed death ligand 1 (PD-L1) | supported | 2021 |
Consumer voice
Lung Foundation Australia welcomed the potential listing of cemiplimab on the PBS, noting that it would provide patients with an additional treatment choice.
Lung Foundation Australia described the potential benefits of the listing of cemiplimab on the PBS including providing patients with an additional treatment choice. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to Stage IV metastatic disease only, excluding locally advanced NSCLC included in TGA label.