Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma

2 The technology

2.1 Trametinib (Mekinist, Novartis Pharmaceuticals) is an inhibitor of MEK1 and MEK2 kinases. Trametinib inhibits the action of the abnormal BRAF protein, with the aim of slowing the growth and spread of the cancer. Dabrafenib (Tafinlar, Novartis Pharmaceuticals) is a selective inhibitor of BRAF V600 kinase activity. It aims to block the activity of mutant protein kinase causing the cancer cells to stop growing and die. Trametinib and dabrafenib have marketing authorisations in the UK, as monotherapies and in combination with each other, for treating adults with unresectable or metastatic melanoma with a BRAF V600 mutation. Both trametinib and dabrafenib are taken orally.

2.2 The most common adverse reactions with trametinib in combination with dabrafenib are pyrexia, fatigue, nausea, headache, chills, diarrhoea, rash, arthralgia, hypertension, and vomiting. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 The acquisition cost of trametinib is £1,120 per pack of 2‑mg tablets (7 tablets per pack) (excluding VAT; Monthly Index of Medical Specialties [MIMS]) and the cost of dabrafenib is £1,400 per pack of 75‑mg tablets (28 tablets per pack) (excluding VAT; British national formulary [BNF] edition 67). The company has agreed patient access schemes with the Department of Health. These schemes provide simple discounts to the list prices of trametinib and dabrafenib with the discounts applied at the point of purchase or invoice. The levels of the discounts are commercial in confidence. The Department of Health considered that these patient access schemes do not constitute an excessive administrative burden on the NHS.