daratumumab (Darzalex)

following a full submission considered under the orphan assessment process:

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

Indication under review: In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

SMC restriction: in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only.

Progression-free survival was significantly longer in patients who received daratumumab in combination with bortezomib and dexamethasone compared with those who received bortezomib and dexamethasone in a phase III study in patients with multiple myeloma who had received at least one prior therapy.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of daratumumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.

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