Dossier assessment

Sotatercept (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-96
Last updated

Report documents

  1. Extract of dossier assessment

    Sotatercept (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 506 kB, EN, PDF
    DOI-Link
    https://doi.org/10.60584/A24-96_en
  2. Dossier assessment

    Sotatercept (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 620 kB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A24-96

Dossier assessment

Indication:

Treatment of pulmonary arterial hypertension in adult patients with WHO Functional Class II to III, to improve exercise capacity

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2025-03-06 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A24-96
Commission
Commission awarded on 15.09.2024 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Heart and circulation
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/A24-96_en

Connected Projects

  1. Addendum

    Sotatercept (pulmonary arterial hypertension) – Addendum to Project A24-96

    Project no.
    A25-14
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Sotatercept (pulmonary arterial hypertension, WHO functional class IV) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-12
    Last updated

    Status: Commission completed

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