isatuximab (Sarclisa)

following a full submission under the end of life and orphan equivalent process:

isatuximab (Sarclisa®) is accepted for restricted use within NHSScotland.

Indication under review: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.

SMC restriction: patients receiving fourth-line therapy.

Addition of isatuximab to pomalidomide plus dexamethasone significantly increased progression-free survival (PFS) in adults with RRMM who had received at least two prior lines of therapy including lenalidomide and a PI.

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

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