Reason for request

First listing

Summary of opinion

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.