2 Information about dabrafenib with trametinib

Marketing authorisation indication

2.1

Dabrafenib (Finlee, Novartis) in combination with trametinib (Spexotras, Novartis) is indicated for:

  • '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 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/or chemotherapy treatment'.

Dosage in the marketing authorisation

Price

2.3

The list price for dabrafenib is £2,800 per 420‑pack of 10 mg dispersible tablets (company submission). The list price for trametinib is £376 per 4.7 mg bottle of 0.05 mg per ml powder for oral solution (company submission).

2.4

The company has a commercial arrangement for each medicine. This makes dabrafenib plus trametinib available to the NHS with a discount. The size of the discount is commercial in confidence.