KERENDIA (finerenone) - Chronic kidney disease

The Committee deems that the clinical benefit of KERENDIA 10 mg and 20 mg (finerenone) film-coated tablets is low in stage 1 or 2 chronic kidney disease (with albuminuria) associated with type 2 diabetes.

Considering:

• the demonstrated superiority of KERENDIA (finerenone) compared to placebo, in combination with the optimised standard of care with ACEi or ARB on the composite primary endpoint, including cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke or hospitalisation for heart failure, with 458 patients in the finerenone group (12.4%) versus 519 patients in the placebo group (14.2%), HR = 0.87; CI95% [0.76; 0.98]; p=0.0264,
• an effect size attributable to the reduction in hospitalisations for heart failure, HR = 0.71; CI95% [0.56; 0.90], p<0.0043,
• the value of this result in a population of diabetes patients with stage 1 or 2 chronic kidney disease and albuminuria, heart failure being one of the risk factors for exacerbation of chronic kidney disease,
• but the absence of any demonstration of a benefit on the first ranked secondary endpoint, which was renal composite endpoint including end-stage renal disease, durable reduction in estimated glomerular filtration rate > 40% compared to baseline or renal death,
• an acceptable comparison versus placebo in view of the concomitant development of KERENDIA (finerenone) in relation to gliflozins,
• the safety profile of KERENDIA (finerenone) marked by a hyperkalaemia risk, which may be increased with concomitant use of medicinal products liable to raise serum potassium levels, e.g. ACEi or ARB, leading to more frequent blood potassium monitoring for some patients, particularly kidney failure patients,
• the lack of robust quality of life results,

the Committee deems that KERENDIA (finerenone) provides no clinical added value (CAV V) in the care pathway for stage 1 or 2 chronic kidney disease (with albuminuria) associated with type 2 diabetes, excluding gliflozins.