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2 Information about axicabtagene ciloleucel

Anticipated marketing authorisation indication

2.1 Axicabtagene ciloleucel (Yescarta, Kite) does not have a marketing authorisation in Great Britain yet. It received a marketing authorisation by the European Commission for: 'the treatment of adult patients with diffuse large B‑cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy'.

Dosage in the marketing authorisation

2.2 The dosage schedule will be available in the summary of product characteristics for axicabtagene ciloleucel.

Price

2.3 The list price of axicabtagene ciloleucel for a single infusion including shipping, engineering and generation of CAR T-cells is £280,451 (company submission).

2.4 The company has a commercial arrangement (simple discount patient access scheme). This makes axicabtagene ciloleucel 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.