Budesonide (Tarpeyo) Form

Budesonide (Tarpeyo™) is a corticosteroid. FDA Approved Indication(s) Tarpeyo is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. 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 Tarpeyo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Immunoglobulin A Nephropathy (must meet all):

1. Diagnosis of primary IgAN confirmed by biopsy;
   2. Provider attestation that secondary causes of IgAN have been ruled out (e.g., IgA vasculitis, liver cirrhosis, viral (hepatitis, human immunodeficiency virus [HIV]) and bacterial infection, inflammatory bowel disease, autoimmune disease such as lupus);
2. Prescribed by or in consultation with a nephrologist;
   4. Age ≥ 18 years;
   5. Confirmation of proteinuria as evidenced by either proteinuria ≥ 1 g/day or urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g despite ACEi or ARB therapy (at up to maximally indicated doses);
3. Recent (within the last 30 days) eGFR ≥ 35 mL/min/1.73 m2;
   7. Member is currently receiving therapy with an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) (at up to maximally indicated doses) for at least 90 days;
4. Tarpeyo is prescribed in combination with an ACEi or ARB;
   9. Failure of two alternative systemic corticosteroids (e.g., methylprednisolone, prednisone), each used for at least 2 months, unless contraindicated or clinically significant adverse effects are experienced;

5. Dose does not exceed 16 mg (4 capsules) per day for 9 months, followed by 8 mg (2 capsules) per day for two weeks. Approval duration: 6 months
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   CLINICAL POLICY Budesonide
   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. Immunoglobulin A Nephropathy (must meet all):
   
   1. 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);
8. Member is responding positively to therapy as evidenced by a reduction in UPCR from baseline;
9. Member has not received more than 38 weeks of treatment with Tarpeyo;
   4. If request is for a dose increase, new dose does not exceed 16 mg (4 capsules) per day for 9 months, followed by 8 mg (2 capsules) per day for two weeks.
      Approval duration: up to a total treatment duration 38 weeks Treatment consists of 9 months of therapy followed by a 2-week dose taper (see Section V below) B. Other diagnoses/indications (must meet 1 or 2):

10. 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 Budesonide

11. 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 ACEi: angiotensin converting enzyme inhibitor ARB: angiotensin receptor blocker eGFR: estimated glomerular filtration rate FDA: Food and Drug Administration IgAN: immunoglobulin A nephropathy UPCR: urine protein-to-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 methylprednisolone prednisone methylprednisolone (IV)

    • prednisolone/prednisone (oral) 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. 0.6 to 0.8 mg/kg PO QD 0.8 to 1 mg/kg PO QD methylprednisolone 1 g IV for 3 days at the start of months 1, 3, and 5
    • prednisolone or prednisone 0.5 mg/kg PO every other day on remaining days Dose Limit/ Maximum Dose 48 mg/day 75 mg/day See dosing regimen Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to budesonide or any ingredients in Tarpeyo • Boxed warning(s): none reported V. Dosage and Administration
      Indication IgAN Dosing Regimen 16 mg PO QD for 9 months. When discontinuing therapy, reduce dose to 8 mg PO QD for the last 2 weeks of therapy. Maximum Dose See dosing regimen Page 3 of 6

    CLINICAL POLICY Budesonide
    VI. Product Availability
    Delayed release capsule: 4 mg VII.