Advice
following a full submission assessed under the end of life and orphan medicine process
 
dabrafenib (Finlee®) is accepted for use within NHSScotland.
 
Indication under review: in combination with trametinib (Spexotras®) for:
• the treatment of paediatric patients aged 1 year and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.
• the treatment of paediatric patients aged 1 year and older with high-grade glioma with a BRAF V600E mutation who have received at least one prior radiation and / or chemotherapy treatment.
 
In an open-label, phase II study, dabrafenib plus trametinib significantly improved overall response rate compared with standard chemotherapy in the first-line treatment of unresectable low-grade glioma and resulted in an overall response rate of 56% in patients with relapsed or refractory high-grade glioma.
 
This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.
 
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

 

Medicine details

Medicine name:
dabrafenib (Finlee)
SMC ID:
SMC2667
Indication:
  • In combination with trametinib for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600 mutation who require systemic therapy.

  • In combination with trametinib for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600 mutation who have received at least one prior radiation and/or chemotherapy treatment.
Pharmaceutical company
Novartis Pharmaceuticals UK Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
09 September 2024