Advice

following a resubmission under the end of life and ultra-orphan medicine process:

tisagenlecleucel (Kymriah®) is accepted 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.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tisagenleceucel. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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

Medicine details

Medicine name:
tisagenlecleucel (Kymriah)
SMC ID:
SMC2200
Indication:

For the treatment of adult patients with relapsed or refractory (r/r) 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
Resubmission
Status
Accepted
Date advice published:
09 September 2019