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  • Question on Document

    Has all of the relevant evidence been taken into account?

  • Question on Document

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Document

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Document

    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?

ID6325 Brexu-cel draft guidance to PM for consultation INDEV version [no CON].docx

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2 Information about brexucabtagene autoleucel

Marketing authorisation indication

2.1

Brexucabtagene autoleucel (Tecartus, Gilead Sciences) is indicated for 'the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor'.

Dosage in the marketing authorisation

Price

2.3

The list price of a course of treatment with brexucabtagene autoleucel is £316,118 (company submission).

2.4

The company has a commercial arrangement, which would have applied if brexucabtagene autoleucel had been recommended.

Carbon Reduction Plan

2.5

Information on the Carbon Reduction Plan for UK carbon emissions for Gilead Sciences will be included here when guidance is published.