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