Advice

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

tisagenlecleucel (Kymriah®) is not recommended for use within NHSScotland.

Indication under review: for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tisagenlecleucel was associated with an overall response rate of 53% in a single-arm, open-label, phase II study in patients with relapsed or 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 submitting 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:
tisagenlecleucel (Kymriah)
SMC ID:
SMC2141
Indication:
for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
Pharmaceutical company
Novartis Pharmaceuticals UK Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Not recommended
Date advice published:
11 March 2019