Axicabtagene ciloleucel for treating relapsed or refractory follicular lymphoma

1 Recommendations

1.1 Axicabtagene ciloleucel is not recommended, within its anticipated marketing authorisation, for treating relapsed or refractory follicular lymphoma after 3 or more systemic therapies in adults.

1.2 This recommendation is not intended to affect treatment with axicabtagene ciloleucel 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 established treatment for relapsed or refractory follicular lymphoma after 3 or more systemic therapies. Treatment can involve trying previous treatments again. Axicabtagene ciloleucel is a CAR T-cell therapy. The therapy uses the person's own immune system cells (T cells), which have been modified to attach to and kill cancer cells.

The clinical evidence is from a small study that suggests that axicabtagene ciloleucel improves the amount of time people have before their condition gets worse and how long they live, but it is uncertain by how much.

Axicabtagene ciloleucel does not meet NICE's criteria to be considered a life-extending treatment at the end of life. This is because people having standard treatments for relapsed or refractory follicular lymphoma after 3 or more systemic therapies are likely to live longer than 2 years.

Because there are uncertainties in the economic model, the cost-effectiveness estimates are also uncertain. They are also all above the range NICE normally considers to be an acceptable use of NHS resources. So, axicabtagene ciloleucel is not recommended for routine use in the NHS.

Axicabtagene ciloleucel has not been reliably shown to have potential to be cost effective. So, axicabtagene ciloleucel is not recommended for use in the Cancer Drugs Fund.