Log in or register to see all Alerts
New HTA Decisions in Germany
December 2021
Drug name
VAZKEPA® (icosapent ethyl)
Amarin Pharmaceuticals Ireland Limited
Decision date
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
Orphan Drug?
No additional benefit
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.
IQWIG concluded that there was no added benefit.