Dabrafenib And Trametinib
Treatment of adult patients with advanced (metastatic) Stage IV non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.
Decisions on record
- Meeting Mar 2025 Recommended Non-small cell lung cancer (NSCLC) with BRAF V600E mutation, advanced or metastatic
- Meeting Mar 2024 Recommended Paediatric glioma (BRAF V600E mutation positive low grade and high grade)
Access path
- Nov 2015Recommended · restricted
- Jul 2019Recommended · restricted
Listing: Restricted → Authority Required
- Dec 2024Recommended · restricted
Comparator changed: placebo → LGG: carboplatin and vincristine (C+V); HGG: basket of…
- Mar 2025Recommended · restricted
Comparator changed: LGG: carboplatin and vincristine (C+V); HGG: basket of chemotherapy…
- PBS listing · Authority Required
From the public summary
The PBAC recommended an Authority Required (STREAMLINED) listing of dabrafenib in combination with trametinib (D+T) for the treatment of adult patients with BRAF V600E mutation positive metastatic (Stage IV) non-small cell lung cancer (NSCLC).PSD · Mar 2025
The PBAC noted the small population of patients with BRAF V600E mutations and the moderate clinical need for additional therapies for NSCLC, which was supported by the consumer comments received.PSD · Mar 2025
The submission presented a cost-minimisation approach (CMA) comparing D+T with pembrolizumab+PBC based on the claim of non-inferiority in terms of effectiveness and safety.PSD · Mar 2025
The submission presented two separate CMAs for NSQ and SQ NSCLC, given the differences in the components of PBC and treatment duration of pembrolizumab+PBC based on histology. The comparator therapies considered in the CMA were pembrolizumab with cisplatin/carboplatin and pemetrexed for NSQ NSCLC and pembrolizumab with carboplatin and paclitaxel for SQ NSCLC.PSD · Mar 2025
D+T has non-inferior efficacy versus pembrolizumab + platinum-based chemotherapy based on ORR, PFS and OS D+T has different but non-inferior safety to pembrolizumab + platinum-based chemotherapy For ECOG PS 2:PSD · Mar 2025
D+T has superior efficacy and safety to platinum-based chemotherapy Source: Table 1.1, p3 of the submission.PSD · Mar 2025
The PBAC noted and welcomed the input from individuals (3), a health care professional and organisations (3) via the Consumer Comments facility on the PBS website. The comments from the health care professional noted the good overall response rate observed with D+T. Comments from individuals noted the high burden of NSCLC on patients and their families and the high cost of D+T.PSD · Mar 2025
The PBAC noted the Lung Foundation Australia and Rare Cancers Australia commented on the importance of having access to targeted therapies for NSCLC. The 5PSD · Mar 2025
Cost-effectiveness
Cost-minimisation approach used; no ICER calculated by design.
The submission presented a cost-minimisation approach (CMA) comparing D+T with pembrolizumab+PBC based on the claim of non-inferiority in terms of effectiveness and safety. PSD · 2025
Decision context
PopulationAdult patients with advanced (metastatic) Stage IV BRAF V600E mutation-positive non-small cell lung cancer with ECOG performance status 0-2.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | Pembrolizumab with platinum-based chemotherapy (ECOG PS 0-1); platinum-based chemotherapy alone (ECOG PS 2) | — | Single-arm · ORR |
| Dec 2024 | Recommended · restricted | LGG: carboplatin and vincristine (C+V); HGG: basket of chemotherapy treatments (carboplatin, vincristine, etoposide, tem | — | RCT · ORR |
| Jul 2019 | Recommended · restricted | placebo | $15k–45k | RCT · RFS |
| Nov 2015 | Recommended · restricted | — | — | — |
Clinical evidence
Consumer voice
Consumer input from individuals, health care professionals, and organisations noted the high burden of NSCLC on patients and families, the high cost of treatment, and strong support for access to targeted therapies including oral treatment options.
Comments from individuals noted the high burden of NSCLC on patients and their families and the high cost of D+T. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to BRAF V600E mutation specifically and requires ECOG performance status 0-2; TGA label covers broader V600 mutations without performance status restriction.