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Draft guidance consultation

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1 Recommendations

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

1.2 This recommendation is not intended to affect treatment with loncastuximab tesirine 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

Standard treatment for relapsed or refractory DLBCL after 2 or more systemic treatments includes polatuzumab vedotin with rituximab and bendamustine (polatuzumab plus BR), and chemotherapy. There is no standard treatment for HGBL, but people are usually offered the same treatments as DLBCL.

Evidence from one clinical trial shows that some people with DLBCL and HGBL having loncastuximab tesirine have all signs and symptoms of their cancer disappear (complete remission). But it was not compared with any other treatments in the trial, so it's not known how it directly compares with standard treatment. The results from indirect comparisons of loncastuximab tesirine with other treatments are very uncertain, but suggest it is as effective as polatuzumab plus BR and more effective than chemotherapy.

Because of their similar clinical effectiveness, only the difference in cost between loncastuximab tesirine and polatuzumab plus BR was considered, and loncastuximab tesirine is much more expensive. For loncastuximab tesirine compared with chemotherapy, even when considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources. So, loncastuximab tesirine is not recommended.