autologous anti-CD19-transduced CD3+ cells (KTE-X19) (Tecartus)

following a full submission assessed under the orphan and end of life process:

autologous anti-CD19-transduced CD3+ cells (KTE-X19) (Tecartus®) is accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment.

Indication under review: for 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.

In a single-arm, open-label, phase II study in patients with relapsed or refractory MCL, autologous anti-CD19-transduced CD3+ cells (KTE-X19) (Tecartus®) improved overall response rate compared with historical controls.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.