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ID6325 Brexu-cel draft guidance to PM for consultation INDEV version [no CON].docx

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ID6325 Brexu-cel draft guidance to PM for consultation INDEV version [no CON].docx

1.1

Brexucabtagene autoleucel should not be used to treat relapsed or refractory mantle cell lymphoma in adults who have had 2 or more lines of systemic treatment that included a Bruton's tyrosine kinase inhibitor.

1.2

This recommendation is not intended to affect treatment with brexucabtagene autoleucel that was funded with managed access before final guidance was published. If this applies, NHS England and the company have an arrangement to make sure people who started treatment during the managed access period can continue the treatment process with brexucabtagene autoleucel.

What this means in practice

Brexucabtagene autoleucel is not required to be funded in the NHS in England to treat relapsed or refractory mantle cell lymphoma in adults who have had 2 or more lines of systemic treatment that included a Bruton's tyrosine kinase inhibitor. It should not be used routinely in the NHS in England.

This is because the available evidence does not suggest that brexucabtagene autoleucel is value for money in this population.

Why the committee made these recommendations

This evaluation reviews the evidence for brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma (NICE technology appraisal guidance 677). It also reviews new evidence collected during the managed access period, which includes evidence from the company's clinical trial and from people having treatment in the NHS in England.

Standard care for relapsed or refractory mantle cell lymphoma in people who have had 2 or more lines of systemic treatment that included a Bruton's tyrosine kinase inhibitor is usually rituximab-containing chemoimmunotherapy (R-BAC).

Evidence comes from a single-arm study of brexucabtagene autoleucel that does not compare it with R-BAC. There are no trials directly comparing brexucabtagene autoleucel with R-BAC. An indirect comparison suggests brexucabtagene autoleucel may increase how long people have before their cancer gets worse and how long they live compared with R-BAC. But this is uncertain.

There are also uncertainties in the economic model because:

  • there is not enough evidence to tell if the cancer can be 'cured' in people having brexucabtagene autoleucel treatment

  • it is not known how long people live because the clinical trial is ongoing

  • the age of people in the model does not represent the likely NHS population who would have brexucabtagene autoleucel treatment

  • the model does not include outcomes for people who start leukapheresis but do not complete infusion with brexucabtagene autoleucel.

The cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. So, brexucabtagene autoleucel should not be used.