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Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer

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2 Information about encorafenib

Marketing authorisation indication

2.1 On 30 April 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product encorafenib (Braftovi). The CHMP adopted a new indication as follows: 'in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy'. Because the marketing authorisation did not include triple therapy (encorafenib plus binimetinib and cetuximab), this appraisal only considers dual therapy.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.

Price

2.3 The list price of encorafenib 75 mg is £1,400 for 42 capsules (excluding VAT; BNF online accessed August 2020). The company has a commercial arrangement. This makes encorafenib available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.