[A21-113] Icosapent ethyl (hypertriglyceridaemia) - Benefit assessment according to §35a Social Code Book V

Last updated 18.02.2022

Project no.:
A21-113

Commission:
Commission awarded on 01.09.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Digestion, metabolism and hormones

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

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

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

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