daratumumab (Darzalex)

following a full submission assessed under the orphan medicine process:

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

Indication under review: in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.

SMC restriction: for use in patients who are ineligible for autologous stem cell transplant (ASCT).

An open-label, phase III study demonstrated that daratumumab plus bortezomib, lenalidomide and dexamethasone had a significantly higher minimal residual disease (MRD)-negativity rate and improved progression free survival (PFS) compared with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma. Results from a transplant ineligible subpopulation were consistent with the intention to treat (ITT) population. Indirect evidence suggested improved PFS versus daratumumab, lenalidomide and dexamethasone but no evidence of a difference for overall survival.

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

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.