ModifiedBlue Cross Blue Shield - IowaPolicy 05.04.97

Wellmark_Kerendia_Policy

Defines prior authorization criteria, continuation criteria, dosing/quantity limits, and billing guidance for Kerendia (finerenone) for members with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM). Applies to Wellmark Blue Cross and Blue Shield members per their benefit contract.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark_Kerendia_Policy

Policy CodePolicy 05.04.97

Change TypeRevised (Jan 2025)

Effective DateAug 1, 2023

Next Review Date

Key ActionKerendia requires prior authorization and will be covered only when the specified initial approval criteria are met; approval duration is 12 months.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed January 2025 and current effective date updated to March 8, 2025.

12 monthsApproval duration

30Quantity limit per 30 days

3Required baseline labs

Coverage Summary

Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist indicated to reduce the risk of eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), consistent with FDA-approved indications. Coverage is covered_with_criteria and aligned with FDA labeling, accepted compendia, and guideline recommendations from the American Diabetes Association (ADA) and KDIGO. Policy number 05.04.97.

Initial Therapy Criteria (Prior Authorization)

Initial Approval

Covered with prior authorization when ALL of the following are met:

ALL of the following

ALL of the following
- The member has a diagnosis of chronic kidney disease (CKD)
- The member has a history of type 2 diabetes mellitus (T2DM)
- ACEi/ARB requirement: The member is currently receiving a maximally tolerated dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) OR the member has experienced an intolerance, allergy or contraindication to an ACEi or ARB
  Either current ACEi/ARB therapy at maximally tolerated dose OR documented intolerance/allergy/contraindication
- Laboratory thresholds
  - Urinary albumin-to-creatinine ratio (UACR) ≥ 30 mg/g (23 mg/mmol)UACR ≥ 30 mg/g (23 mg/mmol)
  - An eGFR ≥ 25 mL/min/1.73 m2eGFR ≥ 25 mL/min/1.73 m2
  - A serum potassium level < 5 mEq/Lserum potassium < 5 mEq/L
- SGLT2 inhibitor status: The member is stable and at goal with a sodium glucose transport protein 2 (SGLT2) inhibitor that is indicated for use in patients with chronic kidney disease OR the member has a history of failure, contraindication, or intolerance to SGLT2 inhibitors
  Either currently stable on an indicated SGLT2 inhibitor OR documented failure/contraindication/intolerance to SGLT2 therapy

Continuation of Therapy Criteria

Continuation of Therapy

Renewal approval criteria (ALL required):

ALL of the following

Clinical response: The member is experiencing clinical improvement with the requested agent
ACEi/ARB status: The member is currently receiving a maximally tolerated dose of an ACEi or ARB OR the member has experienced an intolerance, allergy or contraindication to an ACEi or ARB
SGLT2 inhibitor status: The member is stable and at goal with a sodium glucose transport protein 2 (SGLT2) inhibitor that is indicated for use in patients with chronic kidney disease OR the member has a history of failure, contraindication, or intolerance to SGLT2 inhibitors
The member has a serum potassium level < 5.5 mEq/Lserum potassium < 5.5 mEq/L

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Kerendia requires prior authorization and will be covered only when the specified initial approval criteria are met; approval duration is 12 months.

Documentation Required

Document ACEi/ARB status

Document current use of a maximally tolerated dose of an ACE inhibitor (ACEi) or an angiotensin receptor blocker (ARB), or document intolerance, allergy, or contraindication to ACEi/ARB.

Documentation Required

Document SGLT2 inhibitor status

Document that the member is stable and at goal on an SGLT2 inhibitor indicated for CKD, or document history of failure, contraindication, or intolerance to SGLT2 inhibitors.

Documentation Required

Provide laboratory values

Provide recent urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), and serum potassium values to support eligibility and continuation. Ensure serum potassium meets the specified thresholds for initiation (< 5 mEq/L) and renewal (< 5.5 mEq/L).

Billing Rule

Quantity limit

Quantity limit of 30 tablets per 30 days applies.

Clinical Evidence

reduced primary kidney endpoint vs placeboFIDELIO-DKD

reduced composite cardiovascular endpoint vs placeboFIGARO-DKD

Evidence from two pivotal phase 3 trials supports finerenone’s benefits: FIDELIO-DKD demonstrated that finerenone reduced the primary kidney endpoint (sustained eGFR decline, kidney failure, or renal death) versus placebo, and FIGARO-DKD showed a reduction in the composite cardiovascular endpoint versus placebo. These trial findings underpin guideline recommendations and the policy’s alignment with ADA and KDIGO guidance for use of a nonsteroidal mineralocorticoid receptor antagonist in appropriate patients with T2D and CKD.

Background & Definitions

Kerendia (finerenone) is 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 adults with CKD associated with T2D, and the policy aligns coverage with FDA labeling, compendia, and ADA/KDIGO guideline recommendations.

Scope summary: Applies to Wellmark Blue Cross and Blue Shield members per their benefit contract and defines prior authorization, continuation criteria, dosing/quantity limits (30 tablets per 30 days), and documentation requirements.

Definitions:

CKD: Chronic kidney disease

T2DM / T2D: Type 2 diabetes mellitus

UACR: Urinary albumin-to-creatinine ratio

eGFR: Estimated glomerular filtration rate

Revision History

2023-08-01effective_date

Policy originally became effective on August 1, 2023.

2025-01-01review

Policy was reviewed in January 2025.

2025-03-08effective_date_updateLatest

Document lists Current Effective Date updated to March 8, 2025 following the January 2025 revision.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark_Kerendia_Policy

Policy CodePolicy 05.04.97

Change TypeRevised (Jan 2025)

Effective DateAug 1, 2023

Next Review Date

Key ActionKerendia requires prior authorization and will be covered only when the specified initial approval criteria are met; approval duration is 12 months.

SourceLink

On This Page

OpenPayer

Wellmark_Kerendia_Policy

Coverage Summary

Initial Therapy Criteria (Prior Authorization)

Continuation of Therapy Criteria

Not Medically Necessary / Exclusions

Provider Actions & Billing Rules

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History