Subject: Kerendia PA Policy 4871-A 11-2022

Drug

KERENDIA  (finerenone)

Policy:

FDA-approved Indications
Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). 

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
      •    The patient has a diagnosis of chronic kidney disease (CKD)
            associated with type 2 diabetes (T2D)
AND 
      •    The patient is currently receiving a maximally tolerated dose of
            an angiotensin-converting enzyme inhibitor (ACEi) or
            angiotensin receptor blocker (ARB)
            OR 
      •    The patient has experienced an intolerance to an angiotensin-
            converting enzyme inhibitor (ACEi) or angiotensin receptor
            blocker (ARB)
            OR 
      •    The patient has a contraindication that would prohibit a trial of
            an angiotensin-converting enzyme inhibitor (ACEi) or
            angiotensin receptor blocker (ARB)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Kerendia [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; September 2022. 
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed September 13,2022. 
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed September 13, 2022.
4. ADA’s Standards of Medical Care in Diabetes - 2022. Dia Care. 2022;45(S1):S1-S264. 
5. de Boer IH, Caramori ML, Chan JCN, et al. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney International. 2020;98(4):S1-S115. 
6. Bakris GL, Agarwal R, Anker SD, et. al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. New Engl J Med, 2020;383(23):2219-2229.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 23, 2023