Daratumumab (9, reassessment) (Darzalex®) – Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone

Characteristics

Start date 01.04.2022
Resolution 15.09.2022
INN Daratumumab
Brand name Darzalex®
Pharm. company Janssen-Cilag
G-BA procedure ID 2022-04-01-D-812
Therapeutic area Oncological diseases ORPHAN (turnover exceeded)
Reason for procedure Reassessment: G-BA limitation
Original resolution: Daratumumab (2, reassessment >€50m) (15.02.2018)

G-BA resolution "Anwendungsgebiet des Beschlusses" (German)

Adults with multiple myeloma (MM) who have already received at least one therapy

Subpopulation Indication Comparator
a) Adults with multiple myeloma (MM) who have already received at least one therapy - Bortezomib in combination with pegylated liposomal doxorubicin or - bortezomib in combination with dexamethasone or - lenalidomide in combination with dexamethasone or - Elotuzumab in combination with lenalidomide and dexamethasone or - carfilzomib in combination with lenalidomide and dexamethasone, or - carfilzomib in combination with dexamethasone

9. Associated procedures

Resolution INN Brand name Indication Patients Additional benefit
Daratumumab Darzalex® Multiple myeloma (MM), monotherapy, pre-treated patients 0
2,300
Daratumumab (eingestellt) Darzalex® Multiple myeloma (MM) n.d.
Daratumumab (2, reassessment >€50m) Darzalex® Multiple myeloma (MM), monotherapy; multiple myeloma, at least 1 prior therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone 2,300
7,000 – 9,300
Daratumumab (3) Darzalex® Multiple myeloma (MM), first-line, unsuitable for stem cell transplantation, combination with bortezomib, melphalan and prednisone 3,380 – 3,900
Daratumumab (4) Darzalex® Multiple myeloma (MM), newly diagnosed, patients suitable for autologous stem cell transplantation, combination with bortezomib, thalidomide and dexamethasone 1,800 – 1,900
Daratumumab (5) Darzalex® Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 0
3,479 – 3,670
Daratumumab (6) Darzalex® Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone 440 – 1,030
Daratumumab (7) Darzalex® Multiple Myeloma (MM), at least 1 pretreatment, combination with Pomalidomid and Dexamethason 3,190 – 3,600
Daratumumab (8, reassessment) Darzalex® Multiple myeloma (MM), newly diagnosed, patients not suitable for autologous stem cell transplantation, combination with lenalidomide and dexamethasone 3,470 – 3,670
Daratumumab (9, reassessment) Darzalex® Multiple myeloma (MM), after at least 1 previous therapy, combination with lenalidomide and dexamethasone or bortezomib and dexamethasone 4,700 – 7,000


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