[A21-100] Daratumumab (systemic light chain amyloidosis) - Benefit assessment according to §35a Social Code Book V

Last updated 02.11.2021

Project no.:
A21-100

Commission:
Commission awarded on 01.08.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Haematology

Indication:

Adult patients with newly diagnosed systemic light chain amyloidosis

Result of dossier assessment:
  • Patients for whom bortezomib + cyclophosphamide + dexamethasone is the best individual choice: hint of minor added benefit.
  • Patients for whom a therapy other than bortezomib + cyclophosphamide + dexamethasone is the best individual choice: added benefit not proven.
Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

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