following a full submission considered under the ultra-orphan and end of life process
tisagenlecleucel (Kymriah) is accepted for use within NHSScotland.
Indication under review: treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
Tisagenlecleucel was associated with an overall remission rate of 81% within three months of treatment in a single-arm, open-label, phase II study in paediatric and young adult patients with CD19+ relapsed or refractory B-cell ALL.
SMC advice takes account of the benefit of Patient Access Schemes (PAS) that improve the cost effectiveness of tisagenlecleucel and is contingent upon the continuing availability of this PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
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