Kerendia – NC Standard

Restricted Product(s)

• Kerendia® (finerenone) tablets 

FDA Approved Use

• 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 adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Criteria for Approval of Restricted Product(s)

1. The patient is currently being treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB); OR
   1. The patient has a clinical contraindication/intolerance to all products containing an ACEI or ARB; AND
2. The patient is currently being treated with an antidiabetic agent, such as metformin, insulin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or a glucagon-like peptide-1 (GLP-1) agonist; OR 
   1. The patient has a clinical contraindication/intolerance to all products containing metformin, insulin, a DPP-4 inhibitor, an SGLT2 inhibitor, or a GLP-1 agonist; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

Duration of Approval: (365 days) 1 year

References

All information referenced is from FDA package insert unless otherwise noted below.

American Diabetes Association Professional Practice Committee. 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S219-S230.

Policy Implementation/Update Information

March 2025: Criteria change: Updated ACEI/ARB step to allow if contraindication/intolerance to all. Updated antidiabetic step criteria to include metformin, insulin, DPP4, or GLP1. Removed criteria for high risk of CV or CKD progression.

January 2025: Criteria change: Removed age and diagnosis criteria points.

May 2022: Criteria change: Patients at increased risk for cardiovascular events or CKD progression not required to t/f an SGLT2.

July 2021: Original utilization management criteria issued.