KERENDIA (finerenone)

Self-Administration – oral

Diagnosis considered for coverage:
  • 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:

For diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes:

  • Dose does not exceed 20 mg once daily; AND
  • Patient is 18 years of age or older; AND
  • Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) defined by one of the following:
    • All of the following:
      • Urinary albumin-to-creatinine ratio (UACR) of 30 to 300 mg/g 
      • Estimated glomerular filtration rate (eGFR) 25 to 60 mL/min/1.73 m2 
      • Diabetic retinopathy, OR
    • Both of the following:
      • UACR of greater than or equal to 300 mg/g 
      • eGFR of 25 to 75 mL/min/1.73 m2; AND
  • Patient meets one of the following:
    • Tried a minimum 30-day supply of a maximally tolerated dose and will continue therapy with a generic angiotensin-converting enzyme (ACE) inhibitor or generic angiotensin II receptor blocker (ARB)
    • Patient has a contraindication or intolerance to ACE inhibitors and ARBs
Reauthorization Criteria:

For diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes:

  • Dose does not exceed 20 mg once daily; AND
  • Documentation of positive clinical response to therapy; AND
  • Patient meets one of the following:
    • Patient continues to be on a maximally tolerated dose of ACE inhibitor or ARB
    • Patient has a contraindication or intolerance to ACE inhibitors and ARBs
Coverage Duration: 
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • The recommended starting dose of Kerendia is based on eGFR
    • eGFR 60 mL/min/1.73m2 or greater: 20 mg once daily
    • eGFR 25-59 mL/min/1.73m2: 10 mg once daily
    • eGFR less than 25 mL/min/1.73m2: not recommended
    • The target daily dose of Kerendia is 20 mg
  • Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L
  • Contraindications: 
    • Patients receiving concomitant treatment with strong CYP3A4 inhibitors
    • Patients with adrenal insufficiency
  • Warning for hyperkalemia
  • Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C)
  • Avoid concomitant use with grapefruit or grapefruit juice
  • Breastfeeding not recommended
Policy Updates:
  • 2/15/2022 – New policy approved by P&T.
References:
  • Kerendia Prescribing Information.Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ. July 2021. 
  • Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2020;98(4S): S1-S115.

Last review date: February 15, 2022

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