1 Recommendations
1.1
Dabrafenib with trametinib is recommended, within its marketing authorisation, as an option for treating:
-
low-grade glioma (LGG) with a BRAF V600E mutation in children and young people aged 1 year and over who need systemic treatment
-
high-grade glioma (HGG) with a BRAF V600E mutation in children and young people aged 1 year and over after at least 1 radiation or chemotherapy treatment.
Dabrafenib with trametinib is only recommended if the company provides it according to the commercial arrangements.
Why the committee made these recommendations
Glioma is a type of brain cancer that is classified into LGG or HGG based on how fast it grows. Usual treatment for glioma includes surgery, radiotherapy, chemotherapy and best supportive care.
In LGG, dabrafenib plus trametinib has been directly compared with chemotherapy in a clinical trial in people aged 1 to 17 years. It shows that people who have dabrafenib plus trametinib have longer before their condition gets worse than people who have chemotherapy.
In HGG, dabrafenib plus trametinib has not been directly compared with any treatment. But, indirect comparisons suggest that people aged 1 to 17 years who have dabrafenib plus trametinib have longer before their condition gets worse than people who have chemotherapy or best supportive care.
When considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, dabrafenib plus trametinib is recommended.