Dossier assessment

Bulevirtide (chronic hepatitis D) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-113
Last updated

Report documents

  1. Extract of dossier assessment

    Bulevirtide (chronic hepatitis D) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 651 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-113_en
  2. Dossier assessment

    Bulevirtide (chronic hepatitis D) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 848 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-113

Dossier assessment

Indication:

Chronic hepatitis delta virus infection with compensated liver disease

Result of dossier assessment:
  • Adults: added benefit not proven
  • Children and adolescents 3 to < 18 years of age weighing at least 10 kg: added benefit not proven

Project details

Project no.
A25-113
Commission
Commission awarded on 01.09.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Immune system and infections
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/A25-113_en

Connected Projects

  1. Dossier assessment

    Bulevirtide (chronic hepatitis delta virus infection) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

    Project no.
    G20-19
    Last updated

    Status: Commission completed

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