PHMR

England

Scotland

France

Germany

New HTA Decisions in Germany

December 2021

Drug name

VAZKEPA® (icosapent ethyl)

Company

Amarin Pharmaceuticals Ireland Limited

Decision date

01/12/2021

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Our experience

About PHMR

Therapeutic area

Diabetes and other endocrinal, nutritional and metabolic conditions

Therapeutic sub area

Endocrinal, nutritional and metabolic conditions: general and other

G-BA decision date

15/02/2022

Orphan Drug?

Decision
No additional benefit
Indication
To reduce the risk of cardiovascular events in adults treated with statins and patients at high and elevated cardiovascular risk and elevated triglyceride levels  (≥ 150 mg / dl[≥ 1.7 mmol / l]), as well as proven cardiovascular disease or diabetes mellitus and at least 1 other cardiovascular risk factor. 

Appropriate comparator therapy: maximum tolerated drug therapy as prescribed by a doctor, taking into account statins and cholesterol absorption inhibitors.

Decision Detail

Main study: REDUCE-IT Main drivers of decision: Data from the REDUCE-IT trial was not suitable for benefit assessment as the ACT according to the G-BA was not implemented.

Summary

IQWIG concluded that there was no added benefit.

About PHMR

Our experience