CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY

Defines Cigna prior authorization requirements for Kerendia (finerenone tablets) for FDA-approved indications (chronic kidney disease in adults with type 2 diabetes and heart failure with LVEF ≥40%), including baseline lab thresholds, concomitant therapy requirements or contraindication allowances, duration of approval, and not-covered indications.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY

Policy CodePolicy N/A

Change TypeAdded HF indication; clarified SGLT-2 and intolerance language

Effective DateJul 30, 2025

Next Review Date

Key ActionPrior authorization is required for Kerendia; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Heart Failure indication and criteria were added to the policy (LVEF ≥ 40% with SGLT-2 trial or contraindication/intolerance).

Updated SGLT-2 requirement to 'has tried or is currently receiving' Farxiga, Inpefa, or Jardiance.

Added 'or significant intolerance' option to prescriber-reported contraindication language for ACE inhibitor/ARB criteria.

2Covered FDA Indications

1 yearApproval duration

≥25eGFR initiation threshold (mL/min/1.73 m²)

Serum potassium threshold (mEq/L)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: This policy defines Cigna prior authorization requirements for Kerendia (finerenone) for the FDA‑approved indications of chronic kidney disease (CKD) in adults with type 2 diabetes and heart failure (HF) in adults with left ventricular ejection fraction ≥40%. Effective/last review date: 07/30/2025 (review date noted 07/30/2025; selected revision 08/13/2025). Approvals are provided for 1 year when criteria are met. Approved indications include: CKD with type 2 diabetes (with baseline requirements including eGFR ≥25 mL/min/1.73 m², urine albumin-to-creatinine ratio ≥30 mg/g, and serum potassium ≤5.0 mEq/L, and documentation of ACE inhibitor/ARB use or prescriber‑reported contraindication/intolerance) and HF with LVEF ≥40% (with documentation of trial of or current SGLT-2 therapy or prescriber‑reported contraindication/intolerance, and baseline eGFR ≥25 and serum potassium ≤5.0 mEq/L). Not-covered/high‑level excluded uses include treatment of essential hypertension and concomitant use with spironolactone or eplerenone (among other non‑FDA indications).

Key Thresholds & Surface Stats

Age≥ 18 years

eGFR for initiation≥ 25 mL/min/1.73 m²

Serum potassium≤ 5.0 mEq/L

Urine albumin-to-creatinine ratio≥ 30 mg/g

Left ventricular ejection fraction≥ 40%

Chronic Kidney Disease in Type 2 Diabetes — Initial & Continuation Therapy

Chronic Kidney Disease in a Patient with Type 2 Diabetes (FDA-Approved Indication)

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age≥ 18 years
Patient has a diagnosis of type 2 diabetes
iii. ONE of
- a: Patient is currently receiving a maximally tolerated labeled dosage of an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB)Maximally tolerated labeled dosage

Heart Failure (LVEF ≥40%) — Initial & Continuation Therapy

Heart Failure (FDA-Approved Indication)

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age≥ 18 years
Patient has left ventricular ejection fraction ≥ 40%≥ 40%
iii. ONE of
- a: Patient has tried or is currently receiving ONE of the following SGLT-2 inhibitors: Farxiga (dapagliflozin), Inpefa (sotagliflozin), or Jardiance (empagliflozin)

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Kerendia. Approvals are provided for 1 year when the policy criteria are met.

Documentation Required

Baseline laboratory documentation

Required baseline labs prior to initiation: estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m²; serum potassium ≤ 5.0 mEq/L; and for CKD patients urine albumin-to-creatinine ratio ≥ 30 mg/g.

Applicable Codes

Drug (NDC) - CoveredNDCCovered

No codes listed

Clinical Evidence Summary

Phase III RCT (n=5,734)FIDELIO-DKD: diabetic CKD trial

Phase III RCT (n=7,352)FIGARO-DKD: diabetic CKD trial

Phase III RCT (n=6,001)FINEARTS-HF: HF with LVEF ≥40% trial

Background: Kerendia (finerenone) is a non-steroidal mineralocorticoid receptor antagonist evaluated in Phase III trials FIDELIO-DKD (n=5,734), FIGARO-DKD (n=7,352) for diabetic CKD, and FINEARTS-HF (n=6,001) for HF with LVEF ≥40%. The prescribing information includes a Warning for hyperkalemia, noting increased risk with declining kidney function. Label and policy recommend monitoring serum potassium and eGFR; do not initiate Kerendia if baseline serum potassium is > 5.0 mEq/L or if eGFR is < 25 mL/min/1.73 m².

Background & Definitions

Background/mechanism and scope: Kerendia is a non‑steroidal mineralocorticoid receptor antagonist (nsMRA) indicated to reduce risk of CKD progression and cardiovascular outcomes in adults with CKD associated with type 2 diabetes, and to reduce cardiovascular death and heart failure outcomes in adults with HF with LVEF ≥40%. The label warns about hyperkalemia and recommends monitoring of serum potassium and eGFR; initiation is not recommended when serum potassium is > 5.0 mEq/L or eGFR is < 25 mL/min/1.73 m². This policy defines Cigna prior authorization requirements for Kerendia for those FDA‑approved indications, including baseline lab thresholds, concomitant therapy documentation or allowance for prescriber‑reported contraindication/intolerance, and a 1‑year approval duration.

Term	Definition
Maximally tolerated labeled dosage	The highest dose of ACE inhibitor or ARB tolerated by the patient within the product labeling.

Revision History

08/13/2025selected_revisionLatest

Updated Heart Failure criteria to add 'or is currently receiving' to the SGLT-2 inhibitor requirement (Farxiga, Inpefa, or Jardiance).

07/30/2025early_annual_revision_2

Heart Failure indication and criteria were added to the policy (moved from not recommended to FDA‑Approved Indication with LVEF ≥ 40% and SGLT‑2 requirement or documented contraindication/intolerance).

08/07/2024early_annual_revision_1

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY

Policy CodePolicy N/A

Change TypeAdded HF indication; clarified SGLT-2 and intolerance language

Effective DateJul 30, 2025

Next Review Date

Key ActionPrior authorization is required for Kerendia; approvals are provided for 1 year when criteria are met.

SourceLink

On This Page

b: According to the prescriber, the patient has a contraindication or has experienced significant intolerance to ACE inhibitor and ARB therapy

Prescriber-reported contraindication or significant intolerance allowed

iv. Baseline labs

a: Estimated glomerular filtration rate ≥ 25 mL/min/1.73 m²≥ 25 mL/min/1.73 m²
Baseline eGFR prior to initiation
b: Urine albumin-to-creatinine ratio ≥ 30 mg/g≥ 30 mg/g
Baseline UACR prior to initiation
c: Serum potassium level ≤ 5.0 mEq/L≤ 5.0 mEq/L
Baseline serum potassium prior to initiation

B) Patient is Currently Receiving Kerendia

Patient is ≥ 18 years of age≥ 18 years
Patient has a diagnosis of type 2 diabetes
iii. ONE of
- a: Patient is currently receiving a maximally tolerated labeled dosage of an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB)Maximally tolerated labeled dosage
- b: According to the prescriber, the patient has a contraindication or has experienced significant intolerance to ACE inhibitor and ARB therapy
  Prescriber-reported contraindication or significant intolerance allowed

Top-level: either A) Initial Therapy or B) Patient is Currently Receiving Kerendia must be met

Prior Authorization

Prior authorization required

Prior authorization is required for Kerendia. When the patient meets the policy criteria, approvals are provided for 1 year.

Documentation Required

Baseline laboratory documentation

At baseline prior to initiation, document estimated glomerular filtration rate (eGFR), serum potassium (must be ≤ 5.0 mEq/L), and for CKD patients urine albumin-to-creatinine ratio (must be ≥ 30 mg/g).

Documentation Required

Concomitant therapy or intolerance documentation

Document current receipt of or prior trial of an ACE inhibitor or ARB for CKD, or document a prescriber-reported contraindication or significant intolerance to ACE inhibitor/ARB therapy.

Tried or currently receiving one of listed SGLT-2s

b: According to the prescriber, the patient has a contraindication or has experienced significant intolerance to SGLT-2 inhibitor therapy

Prescriber-reported contraindication or significant intolerance allowed

iv. Baseline labs

a: Estimated glomerular filtration rate ≥ 25 mL/min/1.73 m²≥ 25 mL/min/1.73 m²
Baseline eGFR prior to initiation
b: Serum potassium level ≤ 5.0 mEq/L≤ 5.0 mEq/L
Baseline serum potassium prior to initiation

B) Patient is Currently Receiving Kerendia

Patient is ≥ 18 years of age≥ 18 years
Patient has left ventricular ejection fraction ≥ 40%≥ 40%
iii. ONE of
- a: Patient has tried or is currently receiving ONE of the following SGLT-2 inhibitors: Farxiga (dapagliflozin), Inpefa (sotagliflozin), or Jardiance (empagliflozin)
  Tried or currently receiving one of listed SGLT-2s
- b: According to the prescriber, the patient has a contraindication or has experienced significant intolerance to SGLT-2 inhibitor therapy
  Prescriber-reported contraindication or significant intolerance allowed

Top-level: either A) Initial Therapy or B) Patient is Currently Receiving Kerendia must be met

Documentation Required

Concomitant therapy or intolerance documentation

Document current receipt of or prior trial of an SGLT-2 inhibitor for heart failure, or document a prescriber-reported contraindication or significant intolerance to SGLT-2 inhibitor therapy.

Documentation Required

Concomitant therapy or intolerance documentation

Require documentation of either current receipt or prior trial of ACE inhibitor/ARB (for CKD) and/or SGLT-2 inhibitor (for HF) as applicable, or a prescriber-reported contraindication or significant intolerance to those therapies.

Denial Risk

Not medically necessary for other uses

Claims for Kerendia will be denied as not medically necessary for uses other than the listed FDA-approved indications. Examples include treatment of essential hypertension and concomitant use with spironolactone or eplerenone.

Modified ACE inhibitor/ARB criterion to allow prescriber‑reported 'contraindication or significant intolerance' instead of only contraindication.

08/02/2022annual_revision

Annual revision with no criteria changes.