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 name:
- axicabtagene ciloleucel (Yescarta)
- SMC ID:
- 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