isatuximab (Sarclisa)

following a full submission assessed under the orphan equivalent medicine process:

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

Indication under review: in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

In a phase III study of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant, the addition of isatuximab to bortezomib, lenalidomide, and dexamethasone significantly improved progression-free survival.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.