TislelizumabTevimbra
First-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (OSCC) in combination with chemotherapy.
Decisions on record
- Meeting Nov 2024 Recommended Oesophageal squamous cell carcinoma
- Meeting Nov 2023 Noted Stage IV (metastatic) non-small cell lung cancer (first-line) no PSD
Access path
- TGA registered · Tevimbra
TGA label narrower than the PBS population
- Nov 2024Recommended · restricted
vs nivolumab plus chemotherapy
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (streamlined) listing of tislelizumab under the Section 100 (Efficient Funding of Chemotherapy) Program for the treatment of advanced or metastatic gastro-oesophageal cancer. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost- effectiveness of tislelizumab in this population would be acceptable if it were cost minimised to nivolumab.PSD · Nov 2024
7.2 The PBAC noted that the listing requested in the submission was for the first-line treatment of patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (OSCC). The proposed listing criteria were revised in the pre-PBAC response to be consistent with the current PBS listing for nivolumab as outlined in paragraph 3.6.PSD · Nov 2024
6.28 The submission presented a CMA versus nivolumab. The key components and assumptions of the CMA are presented in Table 11. As the effective price of nivolumab is confidential, the analysis was conducted using the published price of nivolumab. 18PSD · Nov 2024
Based on evidence presented in the submission, safety is assumed to be non- Therapeutic claim: safety inferior.PSD · Nov 2024
6.24 The submission claimed that tislelizumab + chemotherapy is non-inferior in terms of effectiveness and safety compared with nivolumab + chemotherapy.PSD · Nov 2024
6.25 The ESC considered this claim was adequately supported with respect to both effectiveness and safety.PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from 3 organisations (Rare Cancers Australia, Pancare Foundation and the Medical Oncology Group of Australia) via the Consumer Comments facility on the PBS website. The comments described the poor prognosis for patients with oesophageal cancer, the morbidity associated with the disease, and 5PSD · Nov 2024
6.3 The Medical Oncology Group of Australia (MOGA) also expressed its support for the tislelizumab submission. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for tislelizumab, which was limited to 4 (out of a maximum of 5, where 5 and 4 represent the grades with substantial improvement)4, based on a comparison with placebo in RATIONALE-306.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation analysis (CMA) conducted; no ICER calculated by design. Effective price of nivolumab is confidential.
The submission presented a CMA versus nivolumab. The key components and assumptions of the CMA are presented in Table 11. As the effective price of nivolumab is confidential, the analysis was conducted using the published price of nivolumab. PSD · 2024
Decision context
PopulationAdult patients with unresectable, locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (OSCC) who are treatment-naïve to systemic therapy, with WHO performance status no higher than 1, receiving tislelizumab 200 mg every 3 weeks in combination with chemotherapy (platinum plus fluoropyrimidine or paclitaxel plus platinum).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | nivolumab plus chemotherapy | — | RCT · OS |
Consumer voice
Three organisations (Rare Cancers Australia, Pancare Foundation, and the Medical Oncology Group of Australia) provided input describing the poor prognosis and morbidity of oesophageal cancer, and expressing support for tislelizumab as a treatment that may improve overall survival with tolerable toxicity.
The comments described the poor prognosis for patients with oesophageal cancer, the morbidity associated with the disease, and the possibility that treatments for the disease will improve overall survival while having tolerable toxicity. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line treatment with specific chemotherapy combinations; TGA label includes both first-line and post-chemotherapy settings.