Dossier assessment

Resmetirom (metabolic dysfunction-associated steatohepatitis) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-117
Last updated

Report documents

  1. Extract of dossier assessment

    Resmetirom (metabolic dysfunction-associated steatohepatitis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 694 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-117_en
  2. Dossier assessment

    Resmetirom (metabolic dysfunction-associated steatohepatitis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-117

Dossier assessment

Indication:

Adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3)

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

05-03-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-117
Commission
Commission awarded on 15.09.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

DOI

https://doi.org/10.60584/A25-117_en

Connected Projects

  1. Addendum

    Resmetirom (metabolic dysfunction-associated steatohepatitis) – Addendum to Project A25-117

    Project no.
    A26-08
    Last updated

    Status: Commission completed

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