Dossier assessment

Tixagevimab/cilgavimab (COVID-19) – Benefit assessment according to § 35a Social Code Book V

Status
Status: Commission completed
Project no.
A22-111
Last updated

Report documents

  1. Extract of dossier assessment

    Tixagevimab/cilgavimab (COVID-19) – Benefit assessment according to § 35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 649 kB, EN, PDF
  2. Dossier assessment

    Tixagevimab/cilgavimab (COVID-19) – Benefit assessment according to § 35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 786 kB, DE, PDF

Dossier assessment

Indication:

Adults and adolescents, aged 12 years and older and weighing at least 40 kg, with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19

Result of dossier assessment:
  • Patients ≥ 18 years: hint of considerable added benefit
  • Patients ≥ 12 to < 18 years: added benefit not proven

Project details

Project no.
A22-111
Commission
Commission awarded on 17.10.2022 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Airways and respiratory system
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.

Connected Projects

  1. Dossier assessment

    Tixagevimab/cilgavimab (COVID-19) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A23-42
    Last updated

    Status: Commission completed

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