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 name:
- tisagenlecleucel (Kymriah)
- SMC ID:
- 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
- Not recommended
- Date advice published:
- 11 March 2019