EncorafenibBraftovi
Advanced or metastatic non-small cell lung cancer (Stage IV NSCLC) with a BRAF V600E mutation who have not received prior systemic treatment in the metastatic setting.
Decisions on record
- Meeting May 2021 Recommended BRAF V600E-variant metastatic colorectal cancer no PSD
- Meeting Mar 2021 Deferred BRAF V600E-variant metastatic colorectal cancer
- Meeting Nov 2018 Recommended Melanoma
Access path
- TGA registered · Braftovi
TGA label narrower than the PBS population
- Mar 2021Deferred
vs FOLFIRI + cetuximab
- May 2021Deferred
- Nov 2025Recommended · restricted
Comparator changed: FOLFIRI + cetuximab → dabrafenib in combination with trametinib
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended a General Schedule, Authority Required (STREAMLINED) listing of encorafenib in combination with binimetinib (E+B) for the treatment of patients with BRAF V600E mutation positive metastatic (Stage IV) non-small cell lung cancer (NSCLC).PSD · Nov 2025
7.2 The PBAC noted that the submission requested listing of the new strength of binimetinib, 45 mg tablet for the treatment of NSCLC. The PBAC considered that this was reasonable if the 45 mg tablet was listed at the same price per mg as the 15 mg tablet noting that it would reduce pill burden in this population.PSD · Nov 2025
6.51 The submission presented a stepped economic evaluation of E+B with pembrolizumab+PDC as first-line treatment of BRAF V600E-MT mNSCLC, based on the 25 OFFICIALPSD · Nov 2025
OFFICIAL Public Summary Document – November 2025 PBAC Meeting MAIC results between PHAROS and KN-189 trials. An additional analysis was presented against D+T, based on the result of a MAIC between the PHAROS and BRF113928 trials. The pre-PBAC response stated that D+T should be the comparator.PSD · Nov 2025
6.46 Only the claims compared to D+T were considered by the PBAC.PSD · Nov 2025
6.47 The submission described E+B as superior in terms of effectiveness compared with D+T. The ESC considered that the therapeutic conclusions presented in the submission were uncertain as:PSD · Nov 2025
6.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (2) and organisations (4) via the Consumer Comments facility on the PBS website. The comments from the health care professionals noted the good overall response rate observed with E+B and familiarity with the adverse effect profile from its current use in the melanoma and colorectal cancer settings.PSD · Nov 2025
6.3 The PBAC noted the Lung Foundation Australia, the Thoracic Group of Australasia and Rare Cancers Australia commented on the importance of having access to targeted therapies for NSCLC. The Lung Foundation Australia and Rare Cancers Australia highlighted the benefit of oral therapy in allowing patients to be treated at home and noted the high burden of NSCLC.PSD · Nov 2025
Cost-effectiveness
ICER not stated in the publicly available portion of this document.
Decision context
PopulationAdult patients with advanced or metastatic (Stage IV) NSCLC with a BRAF V600E mutation who have not received prior systemic treatment in the metastatic setting, with WHO performance status of 0-2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | dabrafenib in combination with trametinib | — | Single-arm · ORR |
| May 2021 | Deferred | FOLFIRI + cetuximab | — | RCT |
| Mar 2021 | Deferred | FOLFIRI + cetuximab | — | RCT · OS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| BRAF mutation test for metastatic melanoma | BRAF V600 mutation | supported | 2018 |
| BRAF V600 testing for metastatic colorectal cancer | BRAF V600 variant | supported | 2021 |
Consumer voice
Consumer and healthcare professional input highlighted the high burden of NSCLC on patients and families, the financial cost of the therapy, and the importance of oral targeted therapies that allow home-based treatment. Healthcare professionals noted good response rates and familiarity with the adverse effect profile, while patient advocacy groups emphasized that some patients may not be well enou
The comments from the health care professionals noted the good overall response rate observed with E+B and familiarity with the adverse effect profile from its current use in the melanoma and colorectal cancer settings. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line treatment and WHO performance status 0-2; TGA label includes all metastatic patients regardless of prior treatment or performance status.