Cases / 2025-03-01-D-1180
completed2025-03-01D series

Daratumumab

Neubewertung nach Fristablauf: systemische Leichtketten-Amyloidose, Erstlinie, Kombination mit Cyclophosphamid, Bortezomib und Dexamethason

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Brand
Darzalex
Manufacturer
Janssen-Cilag GmbH

G-BA action

final resolution

2025-08-21

Arzneimittel-Richtlinie/Anlage XII: Daratumumab (Neubewertung nach Fristablauf: systemische Leichtketten-Amyloidose, Erstlinie, Kombination mit Cyclophosphamid, Bortezomib und Dexamethason)

Evidence-checked summary

This document changes earlier benefit text. It does not restate a complete final benefit conclusion, so the graph does not infer one. The G-BA issued a decision on 2025-08-21. The official page states that it took effect as follows: 21.08.2025. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

This is the latest validated public action attached to this case. It is separate from the IQWiG assessment result.

Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2025-07-07

67 parsed turns

Oral hearing: Daratumumab (Neubewertung nach Fristablauf: systemische Leichtketten-Amyloidose, Erstlinie, Kombination mit Cyclophosphamid, Bortezomib und Dexamethason)

Official Wortprotokoll · 11 pages

IQWiG comparison

Assessment record versus G-BA action

1 reference

IQWiG assessment findings and the later G-BA action are separate records. Open both to compare them.

A25-40

matched

Daratumumab (systemic light chain amyloidosis) – Benefit assessment according to §35a Social Code Book V

Official assessment PDF · 121 pages

G-BA decisions

Distinct actions and documents

1 decision

2025-08-21

final resolution

Arzneimittel-Richtlinie/Anlage XII: Daratumumab (Neubewertung nach Fristablauf: systemische Leichtketten-Amyloidose, Erstlinie, Kombination mit Cyclophosphamid, Bortezomib und Dexamethason)

This document changes earlier benefit text. It does not restate a complete final benefit conclusion, so the graph does not infer one. The G-BA issued a decision on 2025-08-21. The official page states that it took effect as follows: 21.08.2025. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

3 official documents · 4 cited claims

Official sources

Case document package

7 source
Generic graph relations · 4