tebentafusp (Kimmtrak)

following a second resubmission assessed under the end of life and orphan medicine process:

tebentafusp (Kimmtrak®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Evidence from an open-label, phase III study demonstrated that tebentafusp improved overall survival (OS) compared with investigator’s choice of treatment (which included pembrolizumab monotherapy), in HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. Indirect comparisons suggest improved OS and progression-free survival (PFS) compared with nivolumab plus ipilimumab.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

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