Icosapent-Ethyl (1) – Vazkepa®

Adults with elevated triglyceride levels (≥ 150 mg/dl) and high cardiovascular risk, for the purpose of reducing the risk of cardiovascular events

• Following the publication of the resolution on the G-BA’s website, the G-BA has determined that, in the resolution on the benefit assessment of icosapent ethyl dated 17 February 2022, in the table ‘Summary of results for relevant clinical endpoints’ the individual component ‘cardiovascular death’ should be added under the heading ‘morbidity’.
• As the extent of the only minor positive effects of icosapent ethyl in the REDUCE-IT study is being questioned – particularly with regard to the lack of treatment adjustment during the approximately 5-year treatment period – and cannot be conclusively assessed, the following sentence is added for clarification before the word ‘advantage’: “Overall, no differences relevant to the benefit assessment.”
• Furthermore, following the publication of the resolution on the G-BA’s website, the G-BA noted that, in the table setting out the results of the REDUCE-IT study, an incorrect entry had been made in the ‘Placebo (+ statin + ezetimibe where applicable)’ column regarding the results for the endpoint ‘Total adverse events’ in the ‘Placebo (+ statin + ezetimibe where applicable)’ column.
• Morbidity – cardiovascular death
  • Following the publication of the resolution on the G-BA’s website, the G-BA noted that in the resolution on the benefit assessment of icosapent ethyl dated 17 February 2022, in the table ‘Summary of results for relevant clinical endpoints’ the individual component ‘cardiovascular death’ should be added under the heading ‘Morbidity’.
• Side effects – Total adverse events
  • The figure “4089” is to be replaced by “4090” and the figure “3343 (81.8)” by “3326 (81.3)”.

Courtesy translation only, please refer to the German original.