NICE recommends axicabtagene ciloleucel, another CAR-T cell therapy

In a final appraisal determination, NICE has recommended the CAR-T cell therapy axicabtagene ciloleucel (Yescarta) within the Cancer Drugs Fund for certain patients with non-Hodgkin lymphoma.

NICE recommends axicabtagene ciloleucel within its marketing authorisation, ie for adult patients with relapsed or refractory diffuse large B cell lymphoma or primary mediastinal large B cell lymphoma (both aggressive subtypes of non-Hodgkin lymphoma) after two or more lines of systemic therapy.

CAR-T cell therapy is an innovative personalised cancer immunotherapy that works by genetically modifying a patient’s own T cells to express receptors for a target antigen, in this case CD19, a protein expressed on B cells. The T cells are reinfused into the patient to activate an immune response against malignant B cells in the blood.

In earlier draft guidance, NICE did not recommend the therapy because it was not considered to be cost-effective. However, following negotiations between NHS England and the company Kite-Gilead, who agreed to offer the treatment to the NHS at a lower price, the NICE committee concluded that axicabtagene ciloleucel could be offered through the Cancer Drugs Fund for selected patients, while further date is collected on whether to fund the therapy routinely in the future. Approximately 200 people in England will be eligible for treatment each year, which will be delivered at seven hospitals across the country.

In December 2018, NICE recommended another CAR T-cell therapy, tisagenlecleucel (Kymriah), for use within the Cancer Drugs Fund in young patients (up to 25 years) with relapsed or refractory B cell acute lymphoblastic leukaemia (TA554). However, in a separate appraisal consultation document, it was not recommended for treating relapsed or refractory diffuse large B cell lymphoma in adults because the cost-effective estimates were above the range that NICE considers acceptable.


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