1 Recommendations

1 Recommendations

1.1 Tisagenlecleucel therapy is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies, only if the conditions in the managed access agreement are followed.

1.2 This recommendation is not intended to affect both treatment in preparation for and treatment with tisagenlecleucel that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

There is no standard treatment for relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies. Salvage chemotherapy (that is, chemotherapy to control the disease) is the most common treatment option. Tisagenlecleucel is a chimeric antigen receptor (CAR) T‑cell therapy. It contains the patient's own T cells that have been modified to attach to and kill cancer cells.

Evidence from a single-arm study with short follow-up and a small observational study suggests that people having tisagenlecleucel may live for longer, or have more time before their disease relapses. But longer follow-up from the study is needed and there are no data directly comparing tisagenlecleucel with salvage chemotherapy. To assess the comparative effectiveness of tisagenlecleucel and salvage chemotherapy, data from the first CORAL extension study are used. Limitations in the available data mean that the exact size of the benefit of tisagenlecleucel compared with salvage chemotherapy is difficult to establish.

Tisagenlecleucel meets NICE's criteria to be considered a life-extending treatment at the end of life. All the cost-effectiveness estimates for tisagenlecleucel compared with salvage chemotherapy are uncertain because of limitations in the data. Because some of these estimates are higher than what NICE normally considers an acceptable use of NHS resources and are associated with a high degree of uncertainty, tisagenlecleucel cannot be recommended for routine use in the NHS.

Collecting more data on progression-free survival, overall survival and immunoglobulin usage will reduce the uncertainty in the evidence. Therefore, tisagenlecleucel is recommended for use in the Cancer Drugs Fund.

  • National Institute for Health and Care Excellence (NICE)