KERENDIA (finerenone)

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.