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Kerendia (finerenone) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1158
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:
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:
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:
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