2 Information about tisagenlecleucel

2 Information about tisagenlecleucel

Marketing authorisation

Tisagenlecleucel (Kymriah, Novartis) is indicated for the 'treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy'.

Tisagenlecleucel is an immunocellular CAR T‑cell therapy. It contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR). CAR can attach to another protein on the surface of cancer cells called CD-19. When tisagenlecleucel is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.

Dosage in the marketing authorisation

Treatment with tisagenlecleucel comprises a single‑dose intravenous infusion of tisagenlecleucel. It is intended for autologous use only and the dosage for adults with diffuse large B-cell lymphoma is 0.6 to 6.0x108 CAR-positive viable T cells.

Price

The list price for tisagenlecleucel is £282,000 per infusion (company submission).

The company has a commercial arrangement. This makes tisagenlecleucel available to the NHS with a discount. 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.

  • National Institute for Health and Care Excellence (NICE)