16 June 2016 - Addendum results in a revised benefit assessment for patients with type 2 diabetes mellitus.

The fixed combination of sacubitril with valsartan (Entresto) has been available since November 2015 for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction.

In a previous early benefit assessment, the IQWiG determined there is an indication of a significant additional clinical benefit for all patients with respect to the appropriate comparator therapy enalapril: the positive effects in terms of mortality, hospitalizations and quality of life outweigh the negative effects with no serious side effects.

The addendum examined the benefits of sacubitril with valsartan in patients with diabetes mellitus. For patients without diabetes mellitus the assessment does not change. For patients with diabetes mellitus, there is an indication of a marginal additional clinical benefit instead of a reference to a significant additional benefit.

For more details, go to: https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/sacubitril/valsartan-bei-herzinsuffizienz-zusatznutzen-differenziert.7422.html