2 The technology
2.1 Dabrafenib (Tafinlar, Novartis) is an inhibitor of the BRAF V600 protein kinase. When the activity of protein kinase is blocked, the cancer cells stop growing and die. Dabrafenib has a marketing authorisation in the UK in monotherapy for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
2.2 The summary of product characteristics lists the following very common adverse reactions for dabrafenib: papilloma, decreased appetite, headache, cough, nausea, vomiting, diarrhoea, hyperkeratosis, alopecia, rash, palmar‑plantar erythrodysaesthesia syndrome, arthralgia, myalgia, pain in extremity, pyrexia, fatigue, chills and asthenia. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 The list price of dabrafenib is £1400 for a pack of 75‑mg capsules (28 capsules per pack) and £933.33 for a pack of 50‑mg capsules (28 capsules per pack) (excluding VAT; 'British national formulary' [BNF] edition 67). It is taken orally at a recommended dose of 150 mg twice daily. Novartis has agreed a patient access scheme with the Department of Health that makes dabrafenib available with a discount applied at the point of purchase or invoice. The size of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.