daratumumab (Darzalex)

following a resubmission considered under the end of life and orphan process:

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

Indication under review: As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

SMC restriction: for use as a fourth line treatment option

In a pooled analysis of patients in a phase I/II and a phase II study, with heavily pre-treated multiple myeloma, who received the licensed dosing schedule of daratumumab, there was an overall response rate of 31%. 

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 NHS Scotland or a list price that is equivalent or lower. 

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