Dossier assessment

Icosapent ethyl (hypertriglyceridaemia) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-113
Last updated

Report documents

  1. Extract of dossier assessment

    Icosapent ethyl (hypertriglyceridaemia) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 430 kB, EN, not accessible
  2. Dossier assessment

    Icosapent ethyl (hypertriglyceridaemia) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 706 kB, DE, not accessible

Dossier assessment

Indication:

Reduction of the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and

  • Established cardiovascular disease or
  • diabetes mellitus and at least one further cardiovascular risk factor
Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)
2022-02-18G-BA documents on this decision
A G-BA decision was published.

Project details

Project no.
A21-113
Commission
Commission awarded on 01.09.2021 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
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. Addendum

    Icosapent ethyl (cardiovascular risk reduction) - Addendum to Commission A21-113

    Project no.
    A22-03
    Last updated

    Status: Commission completed

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