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Draft guidance consultation

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1 Recommendations

1.1 Epcoritamab is not recommended, within its marketing authorisation, for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults after 2 or more systemic treatments.

1.2 This recommendation is not intended to affect treatment with epcoritamab 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

Usual treatment for DLBCL after 2 or more treatments is rituximab-based chemoimmunotherapy, polatuzumab vedotin with bendamustine plus rituximab (polatuzumab‑BR), or axicabtagene ciloleucel.

Epcoritamab has not been directly compared with usual treatment in a clinical trial. An indirect comparison suggests that people having epcoritamab live for longer than people taking rituximab-based chemoimmunotherapy, but the results are uncertain. It is not clear from indirect comparisons if people taking epcoritamab live longer or have longer before their cancer gets worse than people having polatuzumab‑BR or axicabtagene ciloleucel.

Because of the uncertainties in the clinical evidence and some uncertainties with the assumptions in the economic model, it is not possible to determine a reliable cost-effectiveness estimate. So epcoritamab is not recommended.