Advice

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