Favourable opinion for reimbursement in the following indications:
“Treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy and;
Treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/orchemotherapy treatment”. First listing.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of FINLEE (dabrafenib) 10 mg dispersible tablet and SPEXOTRAS (trametinib) 0.05 mg/mL powder for oral solution is substantial in the MA indications.
Clinical Added Value
minor
The combination of FINLEE (dabrafenib) 10 mg dispersible tablet and SPEXOTRAS (trametinib) 0.05 mg/mL powder for oral solution provides a minor clinical added value (CAV IV)compared to carboplatin plus vincristine chemotherapy in the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
The combination of FINLEE (dabrafenib) 10 mg dispersible tablet and SPEXOTRAS (trametinib) 0.05 mg/mL powder for oral solution provides a minor clinical added value (CAV IV) in the care pathway for paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
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