CurrentCentenePolicy CP.PMN.266

Finerenone (Kerendia)

Defines medical necessity criteria, initial and continuation approval, dosing limits, exclusions, and appendix therapeutic alternatives for finerenone (Kerendia) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyFinerenone (Kerendia)

Policy CodePolicy CP.PMN.266

Change TypeMaterial clinical updates and dosing/indication additions

Effective DateDec 1, 2021

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

4Q 2025 annual review: added new heart failure indication and accompanying 40 mg dosage strength; for CKD, added criterion requiring serum potassium ≤ 5.0 mEq/L per PI.

4Q 2024 annual review: removed upper eGFR limit of 75 mL/min/1.73 m2 and added concurrent SGLT2 inhibitor use as an option to failure of an SGLT2 inhibitor.

4Q 2023 annual review: no significant changes; references reviewed and updated.

2FDA approved indications

12Initial approval duration (months)

>=25Minimum eGFR (mL/min/1.73 m2)

<=5.0

Maximum serum potassium (mEq/L)

Coverage Summary

Finerenone (Kerendia) is a non‑steroidal mineralocorticoid receptor antagonist indicated for: chronic kidney disease (CKD) associated with type 2 diabetes mellitus (T2DM) to reduce risk of kidney and cardiovascular outcomes, and heart failure with left ventricular ejection fraction (LVEF) ≥ 40% to reduce cardiovascular events. This policy applies to the Commercial, HIM, and Medicaid lines of business and is covered with criteria. Reference: Policy number CP.PMN.266. Effective date: 12.01.21; Last review date: 11.25.

Key thresholds and limits

FDA approved indications2

Initial approval duration12 months

Minimum eGFR threshold>= 25 mL/min/1.73 m2

Minimum UACR threshold>= 30 mg/g

Maximum serum potassium<= 5.0 mEq/L

Tablet limit<= 1 tablet/day

CKD maximum dose<= 20 mg/day

Heart failure maximum dose<= 40 mg/day

Initial Approval Criteria — Chronic Kidney Disease (CKD)

Initial Approval Criteria - Chronic Kidney Disease

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

ALL of the following

- Chronic kidney disease (CKD)
- Type 2 diabetes mellitus (T2DM)
Age>= 18 years

Initial Approval Criteria — Heart Failure

Step Therapy

Step therapy for MRA and SGLT2

Step therapy applies: for heart failure a prior failure of one other MRA (spironolactone or eplerenone) is required unless contraindicated; SGLT2 use or failure requirements also apply as specified in the criteria.

Illinois HIM: step therapy requirement does not apply as of 2026-01-01 per IL HB 5395

Documentation Required

Submit supporting specialty documentation

When applicable, provide documentation of cardiology involvement: prescription by or consultation with a cardiologist or specialty documentation from the prescriber should be submitted to support heart failure indications.

Cardiology consult notes or prescriber specialty documentation

Initial Approval Criteria — Other Diagnoses/Indications

Initial Approval Criteria - Other diagnoses/indications

If request does not match sections above, follow one of the policies below:

Other diagnoses/indications branching

Recent label change - on formulary/PDL: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy and is on the formulary/PDL, refer to the no coverage criteria policy for the relevant line of business: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid)
Recent label change - NOT on formulary/PDL: If the drug has had a recent label change and is NOT on formulary/PDL, refer to the non-formulary policy for the relevant line: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid)
Off-label use: If requested use is NOT listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Continued Therapy (Renewal) Criteria

Continued Therapy - Other diagnoses/indications

Refer to formulary/non-formulary or off-label policies as in Initial Criteria if not specified

Continued therapy - other diagnoses/indications

Recent label change handling for formulary/non-formulary (same policies as initial): CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid) for formulary; CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid) for non-formulary
Off-label use reference: Off-label use policy (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid) if not listed under section III

Billing Rule

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Not authorized indications: Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation per off-label use policies or evidence of coverage documents

Refer to off-label use policies CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid) for exceptions

Denial Risk

Not authorized for non‑FDA uses

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless there is sufficient documentation according to the off‑label use policies or evidence of coverage documents.

Must follow off‑label use policy documentation for exceptions (see CP.CPA.09, HIM.PA.154, CP.PMN.53)

Applicable Codes & Product Availability

Product availability (NDC not specified)mixed

Tablets: 10 mg, 20 mg, 40 mg

Available tablet strengths

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required

Prior authorization is required per Centene policies. Prior authorization may also be required for SGLT2 inhibitors.

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria. Typical required documents include office chart notes and relevant laboratory results (eGFR, UACR, serum potassium).

Office chart notes
Laboratory results (eGFR, UACR, serum potassium)

Clinical Evidence & Definitions

Key RCTs and guidelines referenced include: FIDELIO‑DKD and FIGARO‑DKD trials, the 2022 KDIGO guideline, ADA and AHA/ACC/HFSA heart failure guidelines/consensus documents, and the Kerendia Prescribing Information (updated July 2025).

Definitions

CKDChronic kidney disease

eGFREstimated glomerular filtration rate

UACRUrine albumin creatinine ratio

SGLT2Sodium-glucose co-transporter 2

MRAMineralocorticoid receptor antagonist

Revision History

4Q 2023annual review

Template changes applied to other diagnoses/indications and continued therapy section; no significant clinical policy statement changes (references reviewed and updated).

4Q 2024annual review

Removed upper eGFR limit of 75 mL/min/1.73 m2 and added concurrent SGLT2 inhibitor use as an option to failure of an SGLT2 inhibitor in initial criteria (references reviewed and updated).

4Q 2025annual reviewLatest

Added new heart failure indication and accompanying 40 mg dosage strength; for CKD added criterion requiring serum potassium ≤ 5.0 mEq/L per prescribing information (material).

Policy Summary

PayerCentene

PolicyFinerenone (Kerendia)

Policy CodePolicy CP.PMN.266

Change TypeMaterial clinical updates and dosing/indication additions

Effective DateDec 1, 2021

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria.

SourceLink

On This Page

Estimated glomerular filtration rate (eGFR)

>= 25 mL/min/1.73 m2

Urine albumin creatinine ratio (UACR)>= 30 mg/g

Serum potassium<= 5.0 mEq/L

SGLT2 inhibitor requirement

Member is currently receiving a preferred sodium-glucose co-transporter 2 (SGLT2) inhibitor* (see Appendix B for examples)
Failure of >= 3 consecutive months of a preferred SGLT2 inhibitor*, unless contraindicated or clinically significant adverse effects are experienced

Member is currently receiving an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) at maximally tolerated doses for >= 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated

20 mg per day
1 tablet per day

Prior Authorization

Prior authorization required

Prior authorization is required per Centene policies for Kerendia. Prior authorization may also be required for SGLT2 inhibitors.

Approval duration: 12 months

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation to demonstrate that criteria are met.

Required documentation: office chart notes
Required documentation: relevant laboratory results (eGFR, UACR, serum potassium)
Note: Requests for uses that are non-FDA approved are not authorized unless supported by applicable off-label use policies or evidence of coverage documents.

Prior Authorization

Off‑label/non‑formulary uses — follow applicable policies

If the requested use is not listed in the policy sections for CKD or heart failure, follow the applicable formulary/non‑formulary or off‑label policies and obtain prior authorization as required.

Relevant policy codes: CP.CPA.190 (Commercial), HIM.PA.33 (Marketplace no-coverage) / HIM.PA.103 (Marketplace non-formulary), CP.PMN.255 (Medicaid no-coverage) / CP.PMN.16 (Medicaid non-formulary), CP.CPA.09 (Commercial off-label), HIM.PA.154 (Marketplace off-label), CP.PMN.53 (Medicaid off-label)

Initial approvals are valid for 12 months.

Step Therapy

Step therapy for MRA and SGLT2

Step therapy applies as specified: heart failure requires failure of one other MRA (spironolactone or eplerenone) unless contraindicated; SGLT2 use or failure (≥ 3 months) requirements also apply. Illinois HIM requests are exempt from the step therapy requirement as of 2026-01-01 per IL HB 5395.

MRA failure required for heart failure unless contraindicated
Illinois HIM exemption: IL HB 5395 effective 2026-01-01

Billing Rule

Approval duration

Initial approvals are valid for 12 months.

Denial Risk

Not authorized for non‑FDA uses

Non‑FDA uses not addressed in this policy are not authorized unless sufficient documentation is provided per off‑label use policies or evidence of coverage. Exceptions require following the off‑label documentation requirements.

Follow off‑label use policy documentation for exceptions (CP.CPA.09, HIM.PA.154, CP.PMN.53)