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

axicabtagene ciloleucel (Yescarta®) is not recommended for use within NHSScotland.

Indication under review: Treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.

axicabtagene ciloleucel was associated with an objective response rate of 82% in a single-arm, open-label, phase I/II study in patients with refractory DLBCL.

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

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

The submitting company has indicated their intention to make a resubmission.

Medicine details

Medicine name:
axicabtagene ciloleucel (Yescarta)
for treating relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma
Pharmaceutical company
Kite Pharma, a Gilead Company
BNF chapter
Malignant disease and immunosuppression
Submission type
Not recommended
Date advice published:
11 February 2019