daratumumab (Darzalex)

following a full submission assessed under the orphan medicine process:

daratumumab (Darzalex®) is accepted for use within NHSScotland.

Indication under review: In combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.

In a phase III study in patients with newly diagnosed AL amyloidosis with at least one affected organ, the addition of daratumumab to bortezomib, cyclophosphamide and dexamethasone was associated with a significant improvement in complete haematologic response rate.

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.