TepotinibTepmetko
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations (METex14sk).
Decisions on record
- Meeting Mar 2022 Recommended Non-small cell lung cancer no PSD
- Meeting Nov 2021 Deferred Non-small cell lung cancer (NSCLC)
Access path
- TGA registered · Tepmetko
TGA label narrower than the PBS population
- Nov 2021Recommended
vs pembrolizumab with chemotherapy
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred making a recommendation to list tepotinib for the treatment of locally advanced or metastatic IV non-small cell lung cancer patients who have evidence of a MET proto-oncogene, receptor tyrosine kinase (MET) gene alteration that causes skipping of exon 14 (METex14sk). The PBAC was of a mind to recommend tepotinib pending MSAC advice on the funding of the codependent METex14sk testing.PSD · Nov 2021
7.2 The PBAC noted the relatively small population of patients with NSCLC and METex14sk alterations and the clinical need for additional therapies for NSCLC, which was supported by the consumer comments received.PSD · Nov 2021
6.39 The submission presented a cost-minimisation approach (CMA) for tepotinib compared with pembrolizumab in combination with chemotherapy, based on the claimed non-inferiority of tepotinib to pembrolizumab in combination with chemotherapy. The equi-effective doses assumed in the base case CMA were:PSD · Nov 2021
• Tepotinib 392.78 mg orally administered once daily over 13.35 months; andPSD · Nov 2021
pembrolizumab with chemotherapy, and superior to chemotherapy alone.PSD · Nov 2021
NGS=next generation sequencing; NSCLC=non-small cell lung cancer; PCR=polymerase chain reaction; MET= MET proto-oncogene, receptor tyrosine kinase; METex14sk=MET exon 14 skipping alteration. Source: Table 1-1, pp24-25 of the submission.PSD · Nov 2021
6.2 The PBAC noted and welcomed the input from health care professionals (2) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with tepotinib including disease control in later lines of therapy, maintenance of qualify of life, ease of administration and manageable side effects.PSD · Nov 2021
6.4 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the tepotinib submission, categorising it as one of the therapies of “highest priority for PBS listing” on the basis of the VISION trial.PSD · Nov 2021
Cost-effectiveness
Cost minimisation analysis; tepotinib proposed at effective price of pembrolizumab, no ICER calculated
The submission proposed that the effective price of tepotinib will be based on the effective price of pembrolizumab, on a cost-minimisation basis. PSD · 2021
Decision context
PopulationAdults 18 years or older with histologically and cytologically confirmed Stage IIIB (locally advanced) or Stage IV (metastatic) NSCLC with MET exon 14 skipping alterations, who are either treatment naïve or pre-treated with no more than 2 lines of prior therapy, with WHO performance status of 2 or less.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended | pembrolizumab with chemotherapy | — | Single-arm · ORR |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| MET exon 14 skipping alteration testing in non-small cell lung cancer | MET exon 14 skipping alterations (METex14sk) | supported | 2021 |
| Small gene panel testing for NSCLC | EGFR, ALK, ROS1, MET exon 14, BRAF, KRAS, RET, NTRK1, NTRK2, NTRK3 | supported | 2022 |
Consumer voice
Healthcare professionals and organisations provided input describing benefits of tepotinib including disease control, quality of life maintenance, ease of administration and manageable side effects. The Lung Foundation of Australia noted limited treatment options for METex14sk alterations patients, and MOGA strongly supported PBS listing as a highest priority therapy.
The comments described a range of benefits of treatment with tepotinib including disease control in later lines of therapy, maintenance of qualify of life, ease of administration and manageable side effects. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naïve or ≤2 prior lines and WHO performance status ≤2; TGA label has no such limitations.