Cases / 2022-11-15-D-888
completed2022-11-15D series

Tralokinumab

Neues Anwendungsgebiet: Atopische Dermatitis, 12 bis < 18 Jahre

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Brand
Adtralza
Manufacturer
LEO Pharma GmbH

G-BA action

final resolution

2023-12-21

Arzneimittel-Richtlinie/Anlage XII: Tralokinumab (Neues Anwendungsgebiet: Atopische Dermatitis, 12 bis 17 Jahre) – Kombinationstherapie

Evidence-checked summary

The G-BA issued a final resolution on 2023-12-21. The official page states that it took effect as follows: 21.12.2023. 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.

Final benefit result

G-BA result by patient group

Open decision 6007 →

Patient group

Jugendliche von 12 bis 17 Jahren mit mittelschwerer bis schwerer atopischer Dermatitis, die für eine kontinuierliche systemische Therapie in Frage kommen

Added benefit not proven

Comparator
Dupilumab (ggf. in Kombination mit topischen Glukokortikoiden (TCS) und/oder topischen Calcineurininhibitoren (TCI))

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Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2023-03-27

23 parsed turns

Oral hearing: Tralokinumab (Neues Anwendungsgebiet: Atopische Dermatitis, 12 bis < 18 Jahre)

Official Wortprotokoll · 7 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.

A22-121

matched

Tralokinumab (moderate-to-severe atopic dermatitis in adolescents) – Benefit assessment according to § 35a Social Code Book V

Official assessment PDF · 37 pages

G-BA decisions

Distinct actions and documents

2 decision

2023-05-12

final resolution

Arzneimittel-Richtlinie/Anlage XII: Tralokinumab (Neues Anwendungsgebiet: Atopische Dermatitis, 12 bis 17 Jahre)

The G-BA found no proven added benefit for Jugendliche von 12 bis 17 Jahren mit mittelschwerer bis schwerer atopischer Dermatitis, die für eine kontinuierliche systemische Therapie in Frage kommen. The appropriate comparator was Dupilumab (ggf. in Kombination mit topischen Glukokortikoiden (TCS) und/oder topischen Calcineurininhibitoren (TCI)). The G-BA issued a final resolution on 2023-05-12. The official page states that it took effect as follows: 12.05.2023. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

3 official documents · 4 cited claims

2023-12-21

final resolution

Arzneimittel-Richtlinie/Anlage XII: Tralokinumab (Neues Anwendungsgebiet: Atopische Dermatitis, 12 bis 17 Jahre) – Kombinationstherapie

The G-BA issued a final resolution on 2023-12-21. The official page states that it took effect as follows: 21.12.2023. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

4 official documents · 3 cited claims

Official sources

Case document package

10 source
Generic graph relations · 6