Vemurafenib for treating locally advanced or metastatic BRAF V600 mutation‑positive malignant melanoma

Vemurafenib (Zelboraf, Roche Products) is an oral tyrosine kinase inhibitor of the oncogenic BRAF V600 protein kinase. It has a UK marketing authorisation for 'the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma'. All people starting treatment with vemurafenib should have a positive test for the BRAF V600 mutation. Vemurafenib was developed alongside the Roche cobas 4800 BRAF V600 mutation test, which is commercially available in the European Union.

Vemurafenib is most commonly associated with the following adverse reactions: arthralgia, fatigue, rash, photosensitivity reaction, nausea, alopecia and pruritus. It can also lead to the formation of cutaneous squamous-cell carcinomas. For full details of adverse reactions and contraindications, see the summary of product characteristics.

The recommended dose of vemurafenib is 960 mg (4×240 mg tablets) twice daily (equivalent to a total daily dose of 1,920 mg). The summary of product characteristics states that the doses should be given approximately 12 hours apart, and that treatment with vemurafenib should continue until 'disease progression or the development of unacceptable toxicity'. Vemurafenib costs £1,750 for 1 pack of 56×240 mg tablets (1 week's supply; excluding VAT; BNF September 2012). Costs may vary in different settings because of negotiated procurement discounts. The manufacturer of vemurafenib has agreed a patient access scheme with the Department of Health, in which a discount on the list price of vemurafenib is offered. 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.