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Dossier assessment

Dapagliflozin (kidney disease) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-109
Last updated

Report documents

  1. Extract of dossier assessment

    Dapagliflozin (kidney disease) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 814 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 814 kB, EN, not accessible)

  2. Dossier assessment

    Dapagliflozin (kidney disease) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adults with chronic kidney disease

Result of dossier assessment:
  • Without symptomatic chronic heart failure as comorbidity: hint of considerable added benefit
  • With additional symptomatic chronic heart failure as comorbidity: hint of non-quantifiable added benefit

Additional information

Federal Joint Committee (G-BA)

2022-02-18 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-109
Commission
Commission awarded on 26.08.2021 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Kidneys and urinary 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

    Dapagliflozin (heart failure) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-113
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A19-53
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Dapagliflozin (type 1 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

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    A19-37
    Last updated

    Status: Commission completed

  4. Dossier assessment

    Dapagliflozin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

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  5. Dossier assessment

    Dapagliflozin - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

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    Status: Commission completed

  6. Dossier assessment

    Dapagliflozin (type 2 diabetes mellitus in children and adolescents) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-167
    Last updated

    Status: Commission completed

  7. Addendum

    Dapagliflozin (kidney disease) - Addendum to Commission A21-109

    Project no.
    A22-02
    Last updated

    Status: Commission completed

  8. Dossier assessment

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

    Project no.
    A23-11
    Last updated

    Status: Commission completed

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