Finerenone (Kerendia)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Kerendia be reimbursed by public drug plans as an add-on “to standard of care in adults with heart failure with left ventricular ejection fraction (LVEF) ≥ 40% to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits,” if certain conditions are met.
• Evidence from 1 clinical trial showed that adding Kerendia to standard of care (SOC) therapy, improved outcomes, including reduced cardiovascular (CV) deaths, total heart failure (HF) events, and hospitalizations for HF and/or urgent visits, compared to placebo plus SOC therapy in adult patients with HF with LVEF of 40% or more. The Canadian Drug Expert Committee (CDEC) determined that adding Kerendia to SOC therapy provides acceptable clinical value compared with SOC therapy alone for these patients and addresses the needs identified by both patients and clinicians, such as reducing mortality and lowering the risk of initial and recurrent hospitalizations. This determination was enough for CDEC to recommend that Kerendia be reimbursed. Given that Kerendia is expected to be used in addition to SOC therapy, acceptable clinical value refers to added value of Kerendia in combination with SOC therapy versus SOC therapy alone.
• Kerendia should only be covered when initiated as an add-on to SOC therapy in adults with HF (New York Heart Association [NYHA] class II to IV) with mildly reduced or preserved ejection fraction (LVEF ≥ 40%). Treatment should not be initiated in patients with serum or plasma potassium levels of greater than 5.0 mmol/L (i.e., severe hyperkalemia) or with an estimated glomerular filtration rate (eGFR) of less than 25 mL/min/1.73 m².
• Kerendia should only be reimbursed when prescribed by a clinician who has expertise in managing HF and the cost of Kerendia is reduced. Treatment should be discontinued if the patient develops renal failure or hyperkalemia that cannot be adequately managed. Important budget impact considerations must be addressed for health systems to be able to adopt Kerendia.