following an abbreviated submission:
daratumumab subcutaneous injection (Darzalex®) is accepted for restricted use within NHSScotland.
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.
Following a resubmission under the end of life and orphan medicine process, SMC has previously accepted daratumumab 20mg/mL concentrate for solution for infusion for restricted use as a fourth-line treatment option (SMC No 1205/17).
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.
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Medicine details
- Medicine name:
- daratumumab (Darzalex)
- SMC ID:
- SMC2304
- Indication:
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.
- Pharmaceutical company
- Janssen-Cilag Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Abbreviated
- Status
- Restricted
- Date advice published
- 12 October 2020