Finerenone (Kerendia) Form

Finerenone (Kerendia®) is a non-steroidal mineralocorticoid receptor antagonist. FDA Approved Indication(s) Kerendia is indicated to reduce the risk of sustained estimated glomerular filtration rate (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). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Kerendia is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Kidney Disease (must meet all):

1. Diagnosis of both of the following (a and b): a. CKD; b. T2D;
2. Age ≥ 18 years;
   3. Both of the following (a and b): a. eGFR between 25 and 75 mL/min/1.73 m2; b. Urine albumin creatinine ratio (UACR) ≥ 30 mg/g;
3. Failure of ≥ 3 consecutive months of a preferred sodium-glucose co-transporter 2 (SGLT2) inhibitor (see Appendix B for examples), unless contraindicated or clinically significant adverse effects are experienced;
   Prior authorization may be required for SGLT2 inhibitors
4. Member is currently receiving an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) at maximally tolerated doses for ≥ 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated;

5. Dose does not exceed both of the following (a and b): a. 20 mg per day; b. 1 tablet per day.
   Approval duration: 12 months
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   CLINICAL POLICY Finerenone B. Other diagnoses/indications (must meet 1 or 2):

6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Chronic Kidney Disease (must meet all):
8. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 20 mg per day; b. 1 tablet per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 2 of 6

   CLINICAL POLICY Finerenone

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ACE: angiotensin converting enzyme ARB: angiotensin receptor blocker CKD: chronic kidney disease eGFR: estimated glomerular filtration rate FDA: Food and Drug Administration SGLT2: sodium-glucose co-transporter 2 T2D: type 2 diabetes UACR: urine albumin creatinine ratio Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Doses vary 450 mg/day 40 mg/day 80 mg/day 80 mg/day 16 mg/day 80 mg/day 20 mg/day 8 mg/day ACE inhibitors captopril (Capoten®) enalapril (Vasotec®, Epaned®) fosinopril (Monopril®) lisinopril (Prinivil®, Zestril®, Qbrelis®) perindopril (Aceon®) quinapril (Accupril®) ramipril (Altace®) trandolapril (Mavik®) ARBs candesartan (Atacand®) losartan (Cozaar®) telmisartan (Micardis®) valsartan (Diovan®) SGLT2 Inhibitors Farxiga® (dapagliflozin) Jardiance® (empagliflozin) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 32 mg/day 100 mg/day 80 mg/day 320 mg/day 10 mg PO QD 10-25 mg PO QD 10 mg/day 25 mg/day Doses vary Page 3 of 6

    CLINICAL POLICY Finerenone Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant use with strong CYP3A4 inhibitors, adrenal insufficiency • Boxed warning(s): none V. Dosage and Administration
    Indication CKD associated with T2D Dosing Regimen 10 mg or 20 mg PO QD based on eGFR and serum potassium thresholds. Increase to target dose of 20 mg PO QD after 4 weeks based on eGFR and serum potassium thresholds. Maximum Dose 20 mg/day VI. Product Availability
    Tablets: 10 mg, 20 mg VII.