Finerenone (Kerendia) — Coverage Criteria for CKD with Type 2 Diabetes
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Defines medical necessity and prior authorization criteria for finerenone (Kerendia) for adult members with chronic kidney disease associated with type 2 diabetes under Meridian (Medicaid) lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Finerenone (Kerendia)
Initial Approval Criteria — Chronic Kidney Disease
Covered when ALL of the following are met:
Initial CKD coverage
- Diagnosis of both chronic kidney disease (CKD) AND type 2 diabetes (T2D)
- Age >= 18 years>=18
- Renal function and albuminuria: Both: eGFR >= 25 mL/min/1.73 m2 AND urine albumin-to-creatinine ratio (UACR) >= 30 mg/geGFR >=25 mL/min/1.73 m2; UACR >=30 mg/g
- Dose limit: Requested dose does not exceed both: 20 mg per day AND 1 tablet per day<=20 mg/day; <=1 tablet/day
Requests lacking required documentation may be denied
Continued Therapy — Chronic Kidney Disease
Covered when ALL of the following are met:
Continued therapy criteria
- Prior receipt or continuity: Member is either currently receiving medication via the Centene benefit or previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations
Refer to state-specific addendums for continuity of care (CC.PHARM.03A/03B)
- Response to therapy: Member is responding positively to therapy
- Dose increase limit: If request is for a dose increase, the new dose does not exceed both: 20 mg per day AND 1 tablet per day<=20 mg/day; <=1 tablet/day
Requests for finerenone (Kerendia) that are for non‑FDA approved indications and are not specifically addressed by this policy will not be authorized unless the provider submits sufficient documentation supporting safety and efficacy per applicable off‑label use policies. Refer to the plan off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP.PMN.53 (Medicaid) when pursuing coverage for an unlisted indication.
Key Clinical Thresholds and Dosing
Prior Authorization, Documentation, and Alternatives
Prior authorization required — submit criteria documentation
Prior authorization is required. Submit documentation demonstrating the member meets the initial approval criteria: diagnosis of CKD and type 2 diabetes, age ≥ 18 years, eGFR ≥ 25 mL/min/1.73 m2, UACR ≥ 30 mg/g, and requested dose not exceeding 20 mg/day and 1 tablet/day.
- Include clinical evidence that all Initial Approval Criteria are met (diagnoses, age, eGFR, UACR, dose limits).
Therapeutic alternatives — ACEi, ARB, SGLT2i listed
Therapeutic alternatives listed in the policy include ACE inhibitors, ARBs, and SGLT2 inhibitors; the policy lists these alternatives but does not mandate a specific step-therapy sequence.
- ACE inhibitors (examples and dose limits provided in Appendix B).
- ARBs (examples and dose limits provided in Appendix B).
- SGLT2 inhibitors (e.g., dapagliflozin 10 mg/day; empagliflozin 10–25 mg/day).
- No explicit step-therapy ordering is required by this policy.
Required documentation — labs and chart notes
Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information that verify the member meets all approval criteria.
- Office chart notes documenting CKD and type 2 diabetes diagnoses.
- Recent eGFR value demonstrating ≥ 25 mL/min/1.73 m2.
- Recent UACR result demonstrating ≥ 30 mg/g.
- Prescription details showing requested dose ≤ 20 mg/day and ≤ 1 tablet/day.
Denial risk — insufficient documentation or unsupported off‑label use
Requests may be denied if submitted documentation does not demonstrate that the member meets all approval criteria or if the request is for a non‑FDA indication without off‑label policy support.
- Insufficient or missing office notes, eGFR, or UACR results can lead to denial.
- Non‑FDA indications require sufficient documentation per applicable off‑label use policies (commercial, marketplace, or Medicaid) or evidence of coverage.
Background and Drug Overview
Finerenone (Kerendia) is a non‑steroidal mineralocorticoid receptor antagonist approved to reduce the risk of kidney and cardiovascular outcomes in adults with chronic kidney disease associated with type 2 diabetes. Dosing decisions are based on renal function and serum potassium, and the medication is provided as 10 mg and 20 mg tablets with a target maintenance dose of 20 mg once daily.
For coverage purposes this policy requires patients to be adults (age ≥ 18 years) with chronic kidney disease and type 2 diabetes, have an estimated glomerular filtration rate of ≥ 25 mL/min/1.73 m2, and urine albumin‑to‑creatinine ratio of ≥ 30 mg/g. Dosing limits for approval are a maximum of 20 mg/day and no more than one tablet per day.
Definitions and Drug Details
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