daratumumab (Darzalex)

following an abbreviated submission:

daratumumab subcutaneous injection (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.

Following a submission under the orphan medicine process, SMC has previously accepted daratumumab 20mg/mL concentrate for solution for infusion for restricted use in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only (SMC2180).

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.