1 Recommendations

1.1

Glofitamab plus gemcitabine and oxaliplatin can be used as an option to treat relapsed or refractory diffuse large B‑cell lymphoma not otherwise specified in adults when:

  • they have had 1 line of treatment only, and

  • they are not eligible for an autologous stem cell transplant.

    Glofitamab plus gemcitabine and oxaliplatin can only be used if the company provides it according to the commercial arrangement.

1.2

This recommendation is not intended to affect treatment with glofitamab plus gemcitabine and oxaliplatin 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 healthcare professional consider it appropriate to stop.

What this means in practice

Glofitamab plus gemcitabine and oxaliplatin must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Glofitamab plus gemcitabine and oxaliplatin must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that glofitamab plus gemcitabine and oxaliplatin provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

Why the committee made these recommendations

Usual treatment for relapsed or refractory diffuse large B‑cell lymphoma not otherwise specified in people who cannot have an autologous stem cell transplant is rituximab plus gemcitabine and oxaliplatin (R-GemOx) or polatuzumab vedotin plus rituximab and bendamustine (Pola-BR).

For this evaluation, the company asked for glofitamab plus gemcitabine and oxaliplatin to be considered only for adults who have had 1 line of treatment. This is because it was only compared with treatments used after 1 line of treatment only. This does not include everyone who it is licensed for.

Clinical trial evidence shows that glofitamab plus gemcitabine and oxaliplatin increases how long people have before their cancer gets worse and how long people live compared with R-GemOx.

Glofitamab plus gemcitabine and oxaliplatin has not been directly compared in a clinical trial with Pola-BR. Indirect comparisons suggest it is likely to work as well. But this is uncertain because it is not clear if the evidence represents people who would have treatment in the NHS.

Although there are uncertainties in the evidence, the cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, glofitamab plus gemcitabine and oxaliplatin can be used.