Cases / 2024-08-01-D-1087
completed2024-08-01D series

Maralixibat

Neues Anwendungsgebiet: progressive familiäre intrahepatische Cholestase (PFIC), ≥ 3 Monate

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Brand
Livmarli
Manufacturer
Mirum Pharmaceuticals International B.V.

G-BA action

final resolution

2025-02-06

Arzneimittel-Richtlinie/Anlage XII: Maralixibat (Neues Anwendungsgebiet: progressive familiäre intrahepatische Cholestase (PFIC), ≥ 3 Monate)

Evidence-checked summary

The G-BA found a hint of non-quantifiable added benefit for Erwachsene, Jugendliche und Kinder ab einem Alter von 3 Monaten mit progressiver familiärer intrahepatischer Cholestase. The G-BA issued a final resolution on 2025-02-06. The official page states that it took effect as follows: 06.02.2025. 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.

Final benefit result

G-BA result by patient group

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Patient group

Erwachsene, Jugendliche und Kinder ab einem Alter von 3 Monaten mit progressiver familiärer intrahepatischer Cholestase

Hint of non quantifiable added benefit

Comparator

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Official case record

What happened, in source order

No inferred stages

Consultation record

Oral hearing and Wortprotokoll

1 hearing

2024-12-09

151 parsed turns

Oral hearing: Maralixibat (Neues Anwendungsgebiet: progressive familiäre intrahepatische Cholestase (PFIC), ≥ 3 Monate)

Official Wortprotokoll · 17 pages

IQWiG comparison

Assessment record versus G-BA action

0 reference

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

No IQWiG assessment reference is present on the validated official case page. This is an explicit absence, not a broken graph link.

G-BA decisions

Distinct actions and documents

1 decision

2025-02-06

final resolution

Arzneimittel-Richtlinie/Anlage XII: Maralixibat (Neues Anwendungsgebiet: progressive familiäre intrahepatische Cholestase (PFIC), ≥ 3 Monate)

The G-BA found a hint of non-quantifiable added benefit for Erwachsene, Jugendliche und Kinder ab einem Alter von 3 Monaten mit progressiver familiärer intrahepatischer Cholestase. The G-BA issued a final resolution on 2025-02-06. The official page states that it took effect as follows: 06.02.2025. 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

8 source
Generic graph relations · 5