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Kerendia (finerenone) Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-91158

 

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.            

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

07-01-2024            

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

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

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Overview

Type 2 diabetes is the leading cause of chronic kidney disease (CKD) worldwide. International guidelines for the management of CKD in patients with type 2 diabetes recommend control of hypertension and hyperglycemia, as well as the use of a renin–angiotensin system (RAS) blocker (an angiotensin-converting–enzyme [ACE] inhibitor or angiotensin-receptor blocker [ARB]) and, more recently, a sodium–glucose cotransporter 2 (SGLT2) inhibitor.(2) The International Society of Nephrology Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend ACEIs or ARBs for slowing the progression of CKD in patients with diabetes, with the dose titrated to the highest approved dose that is tolerated. In addition, the KDIGO guidelines also state that glycemic management for patients with type 2 diabetes and CKD should include first-line treatment with metformin and a sodium-glucose contransporter-2 (SGLT2) inhibitor, with further drug therapy as needed for glycemic control, (unless pretreatment eGFR less than 20 ml/min). SGLT2 inhibitors have a large effect on reducing CKD progression that appears to be independent of eGFR. Even when glycemic targets are achieved on metformin, an SGLT2 inhibitor should be added for their beneficial effects. The KDIGO guidelines recommend that the selection of an SGLT2 inhibitor should prioritize agents with documented kidney or cardiovascular benefits and take eGFR into account.(8) Of these, canagliflozin, dapagliflozin, and empagliflozin have obtained FDA approval for reducing the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with CKD at risk of progression.(4-6,9) Nonetheless, despite recommended treatment, a risk of CKD progression remains. Evidence supports a pathophysiological role for overactivation of the mineralocorticoid receptor in cardiorenal diseases, including CKD and diabetes, through inflammation and fibrosis that lead to progressive kidney and cardiovascular dysfunction.(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 Kerendia was based on screening eGFR. The dose of Kerendia 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, Kerendia 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. Kerendia also reduced the incidence of the 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, Kerendia 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)  

In the 2023 edition of the American Diabetes Association’s Standards of Medical Care in Diabetes, a recommendation was made for patients with type 2 diabetes and chronic kidney disease who are at increased risk for cardiovascular events or chronic kidney disease progression. In these patients, consideration should be given for the use of  SGLT2 inhibitors, a glucagon-like peptide 1 agonist (GLP1), or a nonsteroidal mineralocorticoid receptor antagonist (finerenone) is recommended to reduce chronic kidney disease progression and cardiovascular events.(7) The International Society of Nephrology Kidney Disease Improving Global Outcomes (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 renin–angiotensin system (RAS) blocker.(8)

 Safety

Kerendia is contraindicated in patients concomitantly using strong CYP34 inhibitors and in patients with adrenal insufficiency. Treatment with Kerendia should not be initiated if serum potassium is greater than 5 mEq/L. Initiation of treatment with Kerendia is not recommended if estimated glomerular filtration rate (eGFR) is less than 25 mL/min/1.73m^2.(1)

REFERENCES                                                                                                                                                                           

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Target Brand Agent(s)

Target Generic Agent(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Kerendia

finerenone tab

10 MG ; 20 MG

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Kerendia

Finerenone Tab

10 MG

30

Tablets

30

DAYS

Kerendia

Finerenone Tab

20 MG

30

Tablets

30

DAYS

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Kerendia

finerenone tab

10 MG ; 20 MG

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

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

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

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

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

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

      1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
    1. The patient has a diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes and BOTH of the following:
      1. ONE of the following:
        1. The patient will be using an agent containing an angiotensin-receptor enzyme inhibitor (ACEi) (e.g., lisinopril, captopril) or an agent containing an angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan) at a maximally tolerated dose in combination with the requested agent OR
        2. The patient has an intolerance or hypersensitivity to an agent containing an angiotensin-receptor enzyme inhibitor (ACEi) AND an agent containing an angiotensin II receptor blocker (ARB) OR
        3. The patient has an FDA labeled contraindication to ALL agents containing an angiotensin-receptor enzyme inhibitor (ACEi) AND ALL agents containing an angiotensin II receptor blocker (ARB) AND
      2. ONE of the following:
        1. The patient will be using an agent containing a sodium glucose transport protein 2 (SGLT2) inhibitor that is indicated for use in patients with chronic kidney disease (i.e., canagliflozin, dapagliflozin, empagliflozin) in combination with the requested agent OR
        2. The patient has an intolerance or hypersensitivity to an agent containing a sodium glucose transport protein 2 (SGLT2) inhibitor that is indicated for use in patients with chronic kidney disease (i.e., canagliflozin, dapagliflozin, empagliflozin) OR
        3. The patient has an FDA labeled contraindication to ALL agents containing a sodium glucose transport protein 2 (SGLT2) inhibitor that is indicated for use in patients with chronic kidney disease (i.e., canagliflozin, dapagliflozin, empagliflozin) OR
        4. The patient has chronic kidney disease and is at increased risk for cardiovascular events or chronic kidney disease progression OR
    2. The patient has another FDA approved indication for the requested agent and route of administration OR
    3. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
  1. The patient's serum potassium is less than or equal to 5.0 mEq/L AND
  2. The patient's estimated glomerular filtration rate (eGFR) is greater than or equal to 25 mL/min/1.73m^2 AND
  3. The patient's urine albumin-to-creatinine ratio (UACR) is greater than or equal to 30 mg/g AND
  4. If the patient has an FDA approved indication, ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  5. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval:  4 months

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

 

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  2. The patient has had clinical benefit with the requested agent AND
  3. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

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

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

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. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. 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. ALL of the following:
    1. The requested quantity (dose) exceeds the program quantity limit AND
    2. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
    3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  Initial: 4 months; Renewal: 12 months

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.  

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Kerendia_PAQL _ProgSum_ 07-01-2024