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 bortezomib, thalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

The addition of daratumumab to bortezomib, thalidomide and dexamethasone was associated with a significant improvement in stringent complete response rates in patients with newly diagnosed multiple myeloma who were eligible for autologous stem cell transplant.

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.