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  • Question on Consultation

    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?
  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

1 Recommendations

1.1

Lisocabtagene maraleucel (liso‑cel) is not recommended, within its marketing authorisation, for treating the following large B-cell lymphomas that are refractory to, or have relapsed within 12 months after, first-line chemoimmunotherapy in adults:

  • diffuse large B‑cell lymphoma

  • high-grade B‑cell lymphoma

  • primary mediastinal large B-cell lymphoma

  • follicular lymphoma grade 3B.

1.2

This recommendation is not intended to affect treatment with liso‑cel 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.

Why the committee made these recommendations

For this evaluation, the company asked for liso‑cel to be considered only for people who can have a stem cell transplant. This does not include everyone who it is licensed for.

Standard care for relapsed or refractory large B‑cell lymphomas after first-line chemotherapy when a stem cell transplant is suitable is salvage chemotherapy, high-dose chemotherapy and stem cell transplantation.

Clinical trial evidence shows that liso‑cel increases how long people have before they need another line of treatment, or their condition gets worse, compared with standard care. Evidence for how long people live after treatment with liso‑cel is uncertain.

There are uncertainties in the assumptions used in the economic model. This is because the treatments used after liso‑cell and standard care in the clinical trial were different from those used in the NHS. There are also uncertainties with the assumptions about how long people live after having liso‑cel. The cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. So, liso‑cel is not recommended.