Effective Date

Date of Origin   

04-01-2025           

Kerendia®

(finerenone)

Tablets

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)

1

Chronic Kidney Disease (CKD) and Diabetes

Chronic kidney disease (CKD) is diagnosed by blood and urine laboratory tests, which include screening for albuminuria and a low estimated glomerular filtration rate (eGFR). These tests are often paired with biopsies and imaging to determine the underlying cause of renal dysfunction.(2,4) It is crucial to emphasize that CKD, commonly known as diabetic kidney disease when linked to diabetes, affects 20-40% of adults with diabetes.(2) This association underscores the critical need for regular monitoring and early intervention in diabetic patients, as it can significantly reduce the risk of complications. Diabetic kidney disease is associated with increased morbidity and mortality, primarily due to poor cardiovascular outcomes and a progression to end-stage kidney disease.(2,4)

The 2024 American Diabetes Association’s (ADA) Standards of Care in Diabetes guidelines recommend routine annual urinary albumin and eGFR screening for individuals with type 2 diabetes. Treatment of diabetic kidney disease focuses on the optimization of glucose control to prevent the progression of CKD. Additionally, an emphasis is placed on adequate blood pressure control to reduce adverse cardiovascular outcomes and slow the progression of CKD.(2,3) The 2024 International Society of Nephrology Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend that people who have both CKD and diabetes should utilize a comprehensive treatment strategy that emphasizes improving cardiovascular and kidney outcomes.(4)

Both the 2024 ADA Standards of Care in Diabetes and KDIGO guidelines for the management of CKD in patients with type 2 diabetes recommend control of hypertension and hyperglycemia. They suggest treatment with a renin–angiotensin system (RAS) blocker (an angiotensin-converting–enzyme [ACE] inhibitor or angiotensin-receptor blocker [ARB]).(2,3,4) Data has shown that both ACEIs and ARBs slow the progression of CKD in patients with diabetes. Dosing should be titrated to the highest approved dose that is tolerated.(2,3,4) Both guidelines also recommend that these patients should include first-line treatment with metformin and a sodium-glucose cotransporter-2 (SGLT2) inhibitor, (unless pretreatment eGFR is less than 20 ml/min).(2,4) Evidence from several trials have demonstrated that SGLT2 inhibitors appear to reduce CKD progression and cardiovascular events independent of their glucose-lowering effects.(2) The KDIGO guidelines recommend treatment with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) in these patients when glycemic targets have not been reached despite use with metformin and SGLT2 inhibitor treatment, or in patients unable to use those agents.(4) Data suggest that glucagon-like peptide 1 receptor agonists (GLP-1 RAs) may also have direct beneficial effects on the kidney and they also appear to provide cardiovascular protection.(2) The ADA Standards of Care in Diabetes recommends that use of an SGLT2 inhibitor, a glucagon-like peptide 1 agonist (GLP1) or a nonsteroidal mineralocorticoid receptor antagonist (finerenone) be considered for patients with type 2 diabetes and chronic kidney disease to reduce the risk for cardiovascular events or chronic kidney disease progression.(2) The (KDIGO) guidelines recommend a nonsteroidal mineralocorticoid receptor antagonist (finerenone) with proven kidney or cardiovascular benefit for patients with type 2 diabetes, an eGFR greater than or equal to 25 ml/min per 1.73 m^2, normal serum potassium concentration, and albuminuria (greater than or equal to 30 mg/g [greater than or equal to 3 mg/mmol]) despite maximum tolerated dose of a renin–angiotensin system (RAS) blocker.(4) The  ADA guidelines recommend basing glucose-lowering agents selection on an individual’s risk factors, including kidney and cardiovascular risk factors, in addition to glucose control.(2)

Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR-mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation.(1)

Efficacy

The FIDELIO-DKD and FIGARO-DKD studies were randomized, double-blind, placebo-controlled, multicenter studies in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. Both trials excluded patients with known significant non-diabetic kidney disease. All patients were to have a serum potassium less than or equal to 4.8 mEq/L at screening and be receiving standard of care background therapy, including a maximum tolerated labeled dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Patients with a clinical diagnosis of chronic heart failure with reduced ejection fraction and persistent symptoms (New York Heart Association class II to IV) were excluded. The starting dose of finerenone was based on screening eGFR. The dose of finerenone could be titrated during the study, with a target dose of 20 mg daily. The FIDELIO-DKD patients were followed for 2.6 years and the FIGARO-DKD patients were followed for 3.4 years.(1)  

At baseline, 99.8% of patients were treated with an ACEi or ARB. Approximately 97% were on an antidiabetic agent (insulin [64.1%], biguanides [44%], glucagon-like peptide-1 [GLP-1] receptor agonists [7%], sodium-glucose cotransporter 2 [SGLT2] inhibitors [5%]), 74% were on a statin, and 57% were on an antiplatelet agent. In the FIGARO-DKD study, background therapies were similar to the FIDELIO-DKD study.(1)

In the FIDELO-DKD trial, finerenone reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of greater than or equal to 40%, kidney failure, or renal death (HR 0.82, 95% CI 0.73-0.93, p=0.001). The treatment effect reflected a reduction in a sustained decline in eGFR of greater than or equal to 40% and progression to kidney failure. Finerenone also reduced the incidence of the secondary composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), and non-fatal stroke or hospitalization for heart failure (HR 0.86, 95% CI 0.75-0.99, p=0.034). The treatment effect reflected a reduction in CV death, non-fatal MI, and hospitalization for heart failure. In the FIGARO-DKD study, finerenone reduced the incidence of the primary composite endpoint of CV death, non-fatal MI, non- fatal stroke or hospitalization for heart failure (HR 0.87, 95% CI 0.76-0.98, p = 0.026). The treatment effect was mainly driven by an effect on hospitalization for heart failure, though CV death also contributed to the treatment effect.(1)  

 Safety

Finerenone is contraindicated in patients concomitantly using strong CYP3A4 inhibitors and in patients with adrenal insufficiency. Treatment with finerenone should not be initiated if serum potassium is greater than 5 mEq/L. Initiation of treatment with finerenone is not recommended if estimated glomerular filtration rate (eGFR) is less than 25 mL/min/1.73m^2.(1)

1

Kerendia prescribing information. Bayer HealthCare Pharmaceuticals Inc. September 2022.

2

American Diabetes Association Professional Practice Committee; 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S219–S230. https://doi.org/10.2337/dc24-S011.

3

American Diabetes Association Professional Practice Committee; 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S179–S218. https://doi.org/10.2337/dc24-S010.

4

Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018.

Kerendia

finerenone tab

10 MG ; 20 MG

M ; N ; O ; Y

N

Kerendia

Finerenone Tab

10 MG

30

Tablets

30

DAYS

Kerendia

Finerenone Tab

20 MG

30

Tablets

30

DAYS

Kerendia

finerenone tab

10 MG ; 20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kerendia

Finerenone Tab

20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kerendia

Finerenone Tab

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Target Agent(s) will be approved when ONE of the following is met:

1. The requested agent is eligible for continuation of therapy AND ONE of the following:

1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 180 days OR
2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 180 days AND is at risk if therapy is changed OR
3. BOTH of the following:
   1. ONE of the following:
      1. The patient has a medication history of use in the past 180 days, intolerance, or hypersensitivity to a product containing an ACE inhibitor or an ARB OR
      2. The patient has an FDA labeled contraindication to ALL products containing an ACE inhibitor or an ARB AND
   2. ONE of the following:
      1. The patient has a medication history of use in the past 180 days, intolerance, or hypersensitivity to a product containing a DPP-4, GLP-1, insulin, metformin, or SGLT2 OR
      2. The patient has an FDA labeled contraindication to ALL products containing a DPP-4, GLP-1, insulin, metformin, or SGLT2

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
   3. BOTH of the following:
      1. The requested quantity (dose) exceeds than the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months