CurrentmhnPolicy CP.PMN.266

Clinical Policy: Finerenone (Kerendia)

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, excluded indications, and required documentation for coverage of finerenone (Kerendia) for CKD associated with T2DM and for heart failure with LVEF ≥ 40% across Commercial, HIM, and Medicaid lines.

Policy Summary

Payermhn

PolicyClinical Policy: Finerenone (Kerendia)

Policy CodePolicy CP.PMN.266

Change TypeMaterial updates (new HF indication, dose strength, potassium criterion)

Effective Date12.01.21

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

Added new heart failure indication and accompanying 40 mg dosage strength.

Removed upper eGFR limit of 75 mL/min/1.73 m2 and added concurrent SGLT inhibitor use as an option to failure of an SGLT2 inhibitor.

Added requirement for serum potassium ≤ 5.0 mEq/L for CKD indication per prescribing information.

Template and administrative updates and periodic references review occurred in prior annual reviews (2022-2023) with no significant clinical changes.

2FDA-approved indications covered

12 monthsInitial approval duration

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

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<=5.0Serum potassium threshold (mEq/L)

Coverage Summary

Finerenone (Kerendia) is covered with criteria that align to the FDA label and guideline recommendations for adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM) and for adults with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%. Coverage for the CKD indication requires age ≥ 18 years, eGFR ≥ 25 mL/min/1.73 m2, UACR ≥ 30 mg/g, serum potassium ≤ 5.0 mEq/L, ACE inhibitor or ARB at maximally tolerated dose for ≥ 4 weeks, and SGLT2 inhibitor use or documented failure of ≥ 3 months of a preferred SGLT2 unless contraindicated. Dosing limits for CKD do not exceed 20 mg/day and ≤ 1 tablet/day.

Quick policy thresholds and facts

Minimum eGFR>= 25 mL/min/1.73 m2

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

Serum potassium<= 5.0 mEq/L

Minimum age>= 18 years

Initial approval duration12 months

Covered FDA-approved indications2

Initial Approval Criteria — Chronic Kidney Disease

Initial Approval Criteria - Chronic Kidney Disease

Covered when ALL of the following are met:

ALL of the following

Diagnosis of CKD
Diagnosis of T2DM
Age ≥ 18 years>= 18 years
Laboratory thresholds
- eGFR ≥ 25 mL/min/1.73 m2

Initial Approval Criteria — Heart Failure

Initial Approval Criteria - Heart Failure

Covered when ALL of the following are met:

ALL of the following

Diagnosis of heart failure of NYHA Class II, III, or IV
Prescribed by or in consultation with a cardiologist
Age ≥ 18 year>= 18 years
LVEF ≥ 40% (heart failure with mildly reduced or preserved ejection fraction)>= 40% LVEF

Initial Approval Criteria — Other Indications

Initial Approval Criteria - Other diagnoses/indications

If not covered above, follow one of the options:

ANY of the following

If drug recently underwent a label change within last 6 months not reflected in this policy, refer to formulary/no coverage or non-formulary policies for relevant line of business (listed policies CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16).
If requested use is not listed under section III and criterion 1 does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Continued Therapy Criteria

Continued Therapy - All Indications

Covered when ALL of the following are met:

ALL of the following

Prior receipt or continuity
- Currently receiving medication via Centene benefit or previously met initial approval criteria
- Currently receiving medication and enrolled in state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Dose increase limits

Diagnoses/Indications Not Authorized

Diagnoses/Indications NOT authorized

ALL of the following

Non-FDA approved indications that are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required and may also be required for preferred SGLT2 inhibitors; refer to the prior authorization and off‑label/formulary policy numbers provided in the policy for specifics.

Documentation Required

Submit supporting documentation

Providers must submit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

eGFR result (must meet eGFR ≥ 25 mL/min/1.73 m2)
Urine albumin‑to‑creatinine ratio (UACR) (must meet UACR ≥ 30 mg/g)
Serum potassium (must be ≤ 5.0 mEq/L)
Documentation of ACE inhibitor or ARB use and duration or contraindication/history
Documentation of prior SGLT2 inhibitor use or failure (≥ 3 consecutive months) or contraindication

Applicable Codes & Product Availability

Product availability (tablet strengths)mixed

10 mg	Tablet strength
20 mg	Tablet strength
40 mg	Tablet strength

Clinical Evidence & Guidelines

Benefit in HF with mildly reduced/preserved EF2024 NEJM trial reported finerenone reduced cardiovascular events in heart failure with LVEF ≥ 40%

Policy references key guideline and evidence sources and states alignment with them: KDIGO 2022 guidance and the ADA Standards of Care (2025) are cited regarding diabetes management in CKD and redirection to SGLT2 therapy; the 2022 AHA/ACC/HFSA heart failure guideline is cited for heart failure management and the 2024 NEJM heart failure trial is referenced for the new HF indication. The policy explicitly aligns coverage criteria with these guidelines and updated evidence, including redirection to SGLT2 inhibitors where applicable and incorporation of the newer heart failure indication.

Background & Definitions

Finerenone is a non-steroidal mineralocorticoid receptor antagonist indicated to reduce the risk of kidney and cardiovascular outcomes in adults with CKD associated with T2DM and to reduce cardiovascular events in adults with heart failure with LVEF ≥ 40%. The policy mirrors FDA-approved indications and dosing guidance (tablet strengths 10 mg, 20 mg, 40 mg) and aligns coverage to the prescribing information and guideline recommendations.

Term	Definition
CKD	Chronic kidney disease
T2DM	Type 2 diabetes mellitus
eGFR	Estimated glomerular filtration rate
UACR	Urine albumin creatinine ratio
SGLT2	Sodium-glucose co-transporter 2 inhibitor

Revision History

4Q2022administrative

Template and administrative update: added redirection to SGLT inhibitor per ADA guideline; references reviewed. (no material clinical policy changes indicated in this review.)

4Q2023administrative

Template and references review: no significant clinical changes; template changes applied to other diagnoses/indications and continued therapy sections. (no material clinical policy changes.)

4Q2024revised

Policy Summary

Payermhn

PolicyClinical Policy: Finerenone (Kerendia)

Policy CodePolicy CP.PMN.266

Change TypeMaterial updates (new HF indication, dose strength, potassium criterion)

Effective Date12.01.21

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

>= 25 mL/min/1.73 m2

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

Serum potassium ≤ 5.0 mEq/L<= 5.0 mEq/L

SGLT2 inhibitor status (ONE of)

Member is currently receiving a preferred SGLT2 inhibitor
Failure of ≥ 3 consecutive months of a preferred SGLT2 inhibitor, unless contraindicated or clinically significant adverse effects are experienced>= 3 months

Member is currently receiving an ACE inhibitor or ARB at maximally tolerated doses for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced>= 4 weeks

Dose limits

Dose does not exceed 20 mg per day<= 20 mg/day
Dose does not exceed 1 tablet per day<= 1 tablet/day

Laboratory thresholds

eGFR ≥ 25 mL/min/1.73 m2>= 25 mL/min/1.73 m2
Serum potassium ≤ 5.0 mEq/L<= 5.0 mEq/L

Failure of one other mineralocorticoid receptor antagonist (spironolactone or eplerenone), unless contraindicated or clinically significant adverse effects are experienced

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

SGLT2 inhibitor status (ONE of)

Member is currently receiving a preferred SGLT2 inhibitor
Failure of ≥ 3 consecutive months of a preferred SGLT2 inhibitor, unless contraindicated or clinically significant adverse effects are experienced>= 3 months

Dose limits

Dose does not exceed 40 mg per day<= 40 mg/day
Dose does not exceed 1 tablet per day<= 1 tablet/day

If request is for a dose increase, new dose does not exceed 1 tablet per day<= 1 tablet/day

Indication-specific max

For CKD: 20 mg per day<= 20 mg/day
For heart failure: 40 mg per day<= 40 mg/day

Continued Therapy - Other diagnoses/indications

Follow same redirection rules as initial other indications:

ANY of the following

Refer to formulary/no coverage or non-formulary policies if label change occurred (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If use not listed under section III and previous rule does not apply, refer to off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Step Therapy

Step therapy for SGLT2 and MRA

Step therapy requires current use of a preferred SGLT2 inhibitor or failure of ≥ 3 consecutive months of a preferred SGLT2 inhibitor (unless contraindicated). For heart failure, failure of one other mineralocorticoid receptor antagonist (spironolactone or eplerenone) is required unless contraindicated; note that for Illinois HIM requests the MRA step therapy requirement does not apply as of 2026‑01‑01 per IL HB 5395.

Billing Rule

Approval duration

Authorizations for initial approvals (both CKD and heart failure indications) are approved for 12 months.

Documentation Required

Continuity of care

For continued therapy, providers must document that the member is responding positively to treatment and provide evidence of prior approval or that the member is enrolled in a state continuity of care program as applicable (see state addendums referenced).

Evidence of prior approval or enrollment in state continuity programs (see addendums CC.PHARM.03A and CC.PHARM.03B)
Clinical notes showing positive response to therapy

Material change: Removed upper eGFR limit of 75 mL/min/1.73 m2 and added concurrent SGLT inhibitor use as an option to failure of an SGLT2 inhibitor in initial criteria. Detail: for initial criteria, the policy eliminated the prior upper eGFR cap and allowed use of a concurrent SGLT inhibitor as an alternative to documenting failure of an SGLT2 inhibitor per competitor analysis and guidelines.

4Q2025addedLatest

Material change: Added heart failure indication and 40 mg tablet strength; clarified serum potassium requirement for CKD. Detail: the policy was updated to add an FDA-aligned heart failure indication (LVEF ≥ 40%) with dosing limits up to 40 mg/day and the product availability was expanded to include a 40 mg tablet; for CKD the policy added a serum potassium requirement of ≤ 5.0 mEq/L per the prescribing information.