following an abbreviated submission:
daratumumab subcutaneous injection (Darzalex®) is accepted for use within NHSScotland.
Indication under review: in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Following a submission under the orphan medicine process, SMC has previously accepted daratumumab concentrate for solution for infusion in combination with bortezomib, thalidomide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (SMC2302).
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.
Download detailed advice728KB (PDF)
Medicine details
- Medicine name:
- daratumumab (Darzalex)
- SMC ID:
- SMC2326
- Indication:
In combination with bortezomib, thalidomide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
- Pharmaceutical company
- Janssen-Cilag Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Abbreviated
- Status
- Accepted
- Date advice published
- 18 January 2021
The Marketing Authorisation for daratumumab solution for injection has been extended to include use, in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. SMC will not review this minor change to the indication.