Pharmacy Prior Authorization Criteria

Kerendia (finerenone)

Indications for Prior Authorization

Kerendia (finerenone)

• For diagnosis of Chronic Kidney Disease Associated with Type 2 Diabetes
  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).

Criteria

Kerendia

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
AND
• Urine albumin-to-creatinine ratio (UACR) greater than or equal to 30 mg/g
AND
• Estimated glomerular filtration rate (eGFR) greater than or equal to 25 mL/min/1.73 m2
AND
• Serum potassium level less than or equal to 5.0 mEq/L prior to initiating treatment
AND
• One of the following:
• Minimum 30-day supply trial of a maximally tolerated dose and will continue therapy with one of the following [2]:
• Generic angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
• Generic angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
OR
• Patient has a contraindication or intolerance to ACE inhibitors and ARBs
AND
• One of the following:
• Patient is on a stable dose and will continue therapy with a sodium-glucose cotransporter-2 (SGLT2) inhibitor (e.g., Farxiga [dapagliflozin], Jardiance [empagliflozin])
OR
• Patient has a contraindication or intolerance to an SGLT2 inhibitor (e.g., Farxiga [dapagliflozin], Jardiance [empagliflozin])

Kerendia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy
AND
• One of the following:
• Patient continues to be on a maximally tolerated dose of ACE inhibitor or ARB
OR
• Patient has a contraindication or intolerance to ACE inhibitors and ARBs
AND
• One of the following:
• Patient continues to be on an SGLT2 inhibitor (e.g., Farxiga [dapagliflozin], Jardiance [empagliflozin])
OR
• Patient has a contraindication or intolerance to an SGLT2 inhibitor (e.g., Farxiga [dapagliflozin], Jardiance [empagliflozin])

P & T Revisions

2024-09-19, 2024-01-11, 2022-09-23, 2021-10-12

References

1. Kerendia Prescribing Information. Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ. September 2022.
2. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022;102(5S): S1-S127.

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Revision History

• 2024-09-19: 2024 annual review: no criteria changes.
• 2024-01-11: 2023 annual review: Updated initial and reauth criteria to add requirement for concomitant use with an SGLT2i. Updated standard reauth from "documentation of.." to "patient demonstrates positive clinical response to therapy".
• 2022-09-23: Annual review: Updated initial authorization criteria.
• 2021-10-12: New Program

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