following a full submission:
daratumumab (Darzalex®) is not recommended for use within NHSScotland.
Indication under review: in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
In an open-label, phase III study, the addition of daratumumab to bortezomib, melphalan, and prednisone was associated with a significant improvement in progression-free survival.
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Medicine details
- Medicine name:
- daratumumab IV and SC (Darzalex)
- SMC ID:
- SMC2416
- Indication:
In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
- Pharmaceutical company
- Janssen-Cilag Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 09 May 2022