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TAFINLAR - MEKINIST (tramétinib/ dabrafénib)
Reason for request
Key points
Now favourable opinion for reimbursement in advanced non-small cell lung cancer (NSCLC) only in patients with a BRAF V600E mutation, as second or later-line treatment following the failure of chemotherapy and/or immunotherapy. This opinion is subject to the collection of observational data within a maximum period of 2 years with a view to reevaluation.
Unfavourable opinion for reimbursement in other situations as second or later-line treatment. As a reminder, unfavourable opinion for reimbursement in adult patients with advanced NSCLC with a BRAF V600 mutation as first-line treatmen
What therapeutic improvement?
No clinical added value.
Role in the care pathway?
The care pathway for advanced NSCLC must be defined in the context of multidisciplinary review meetings, based firstly on the presence of molecular abnormalities (in particular, EGFR mutation, ALK or ROS1 translocations), then PD-L1 tumour expression, as well as tumour histology (squamous or non-squamous), age, ECOG performance status and patient preferences.
Role of TAFINLAR / MEKINIST in the care pathway:
The TAFINLAR / MEKINIST (dabrafenib / trametinib) combination is a second and later-line treatment following the failure of chemotherapy and/or immunotherapy in adult patients with advanced NSCLC with a BRAF V600E mutation. The TAFINLAR / MEKINIST combination has no role in the treatment of adult patients with advanced NSCLC with a BRAF V600 mutation in other situations as second or later-line treatment.
As a reminder, the TAFINLAR / MEKINIST combination has no role as first-line treatment in adult patients with advanced NSCLC with a BRAF V600 mutation (including a V600E mutation).
Clinical Benefit
| Low |
the clinical benefit of the TAFINLAR / MEKINIST combination is low in the treatment of adult patients with advanced NSCLC only in patients with a BRAF V600E mutation, as second or later-line treatment following the failure of chemotherapy and/or immunotherapy. The Committee makes maintenance of the clinical benefit conditional on the collection of observational data in patients treated with the TAFINLAR / MEKINIST combination for advanced NSCLC with a BRAF V600 mutation with a view to reevaluation of the TAFINLAR / MEKINIST combination within a period of 2 years (see 010. Other Committee recommendations).
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| Insufficient |
The clinical benefit is insufficient to justify its funding by the French national health insurance system in other second and later-line treatment situations.
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Clinical Added Value
| no clinical added value |
TAFINLAR / MEKINIST combination provides no clinical added value (CAV V) in the management of patients with NSCLC with a BRAF V600E mutation, as second or later-line treatment following the failure of chemotherapy and/or immunotherapy.
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