Dossier assessment

Dapagliflozin (heart failure with preserved ejection fraction) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-11
Last updated

Report documents

  1. Extract of dossier assessment

    Dapagliflozin (heart failure with preserved ejection fraction) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 765 kB, EN, not accessible
  2. Dossier assessment

    Dapagliflozin (heart failure with preserved ejection fraction) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 958 kB, DE, not accessible

Dossier assessment

Indication:

Adults with symptomatic chronic heart failure with left ventricular ejection fraction > 40%

Result of dossier assessment:
  • Without type 2 diabetes mellitus and without chronic kidney disease: hint of non-quantifiable added benefit
  • With/without type 2 diabetes mellitus and with chronic kidney disease: hint of non-quantifiable added benefit
  • With type 2 diabetes mellitus and without chronic kidney disease: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2023-08-17 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-11
Commission
Commission awarded on 27.02.2023 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.

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