Cases / 2025-11-15-D-1266
completed2025-11-15D series

Selumetinib

Neues Anwendungsgebiet: Neurofibromatose Typ 1 (≥ 18 Jahre

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Brand
Koselugo
Manufacturer
Alexion Pharma Germany GmbH

G-BA action

final resolution

2026-05-07

Arzneimittel-Richtlinie/Anlage XII: Selumetinib (Neues Anwendungsgebiet: Neurofibromatose Typ 1 (≥ 18 Jahre))

Evidence-checked summary

The G-BA found an indication of minor added benefit for Erwachsene mit symptomatischen, inoperablen plexiformen Neurofibromen (PN) bei Neurofibromatose Typ 1 (NF1). The appropriate comparator was • Best-Supportive-Care. The G-BA issued a final resolution on 2026-05-07. The official page states that it took effect as follows: 07.05.2026. 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 7809 →

Patient group

Erwachsene mit symptomatischen, inoperablen plexiformen Neurofibromen (PN) bei Neurofibromatose Typ 1 (NF1)

Indication of minor added benefit

Comparator
• Best-Supportive-Care

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Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2026-03-23

75 parsed turns

Oral hearing: Selumetinib (Neues Anwendungsgebiet: Neurofibromatose Typ 1 (≥ 18 Jahre))

Official Wortprotokoll · 14 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.

A25-147

matched

Selumetinib (plexiform neurofibromas in adults with neurofibromatosis type 1) – Benefit assessment according to §35a Social Code Book V

Official assessment PDF · 76 pages

G-BA decisions

Distinct actions and documents

1 decision

2026-05-07

final resolution

Arzneimittel-Richtlinie/Anlage XII: Selumetinib (Neues Anwendungsgebiet: Neurofibromatose Typ 1 (≥ 18 Jahre))

The G-BA found an indication of minor added benefit for Erwachsene mit symptomatischen, inoperablen plexiformen Neurofibromen (PN) bei Neurofibromatose Typ 1 (NF1). The appropriate comparator was • Best-Supportive-Care. The G-BA issued a final resolution on 2026-05-07. The official page states that it took effect as follows: 07.05.2026. The page lists Arzneimittel-Richtlinie, Anlage XII: Nutzenbewertung nach § 35a SGB V as the normative target.

2 official documents · 4 cited claims

Official sources

Case document package

7 source
Generic graph relations · 5