ModifiedCentenePolicy CP.PHAR.572

Budesonide (Tarpeyo) for IgA Nephropathy

Defines Centene medical necessity criteria, dosing, and coverage limits for Tarpeyo (budesonide) to reduce loss of kidney function in adults with primary IgA nephropathy; applies to commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyBudesonide (Tarpeyo) for IgA Nephropathy

Policy CodePolicy CP.PHAR.572

Change TypeCriteria revised (1Q 2026)

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, labs) showing biopsy-confirmed IgAN, proteinuria and eGFR results, and ACEi/ARB treatment history.

SourceLink

POLICY UPDATE CHANGES

Removed requirement of one alternative systemic corticosteroid and revised criterion for proteinuria ≥ 0.5 g/day per updated KDIGO 2025 guidance.

Added requirement: recent (within the last 30 days) eGFR ≥ 35 mL/min/1.73 m2.

Revised continuation approval duration to up to a total treatment duration of 38 weeks (9 months plus 2-week taper).

>=18Minimum age

>=0.5 g/dayProteinuria threshold

>=35 mL/mineGFR requirement

16 mg/dayDosing limit

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38 weeksApproval length

Coverage Criteria for Tarpeyo (budesonide)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy for IgAN: 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, HIV) and bacterial infection, inflammatory bowel disease, autoimmune disease such as lupus); 3. Prescribed by or in consultation with a nephrologist; 4. Age >= 18 years; 5. Confirmation of proteinuria as evidenced by either proteinuria >= 0.5 g/day or urine protein-to-creatinine ratio (UPCR) >= 0.8 g/g despite ACEi or ARB therapy (at up to maximally indicated doses); 6. 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; 8. Tarpeyo is prescribed in combination with an ACEi or ARB; 9. Dose does not exceed 16 mg (4 capsules) per day for 9 months, followed by 8 mg (2 capsules) per day for two weeks.see nodes

Approval duration: 6 months

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation Therapy for IgAN: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by a reduction in UPCR from baseline; 3. Member has not received more than 38 weeks of treatment with Tarpeyo; 4. If request is for a dose increase, the 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.up to 38 weeks total treatment

Approval duration: up to a total treatment duration 38 weeks

Other/Off-label Uses — Criteria for other diagnoses/indications

For other diagnoses/indications

Other Indications / Off-label Uses: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., newly approved indication, age expansion, new dosing regimen), follow formulary/no-coverage or non-formulary redirection policies for the relevant line of business as applicable (see referenced policies); 2. If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.see referenced policies

See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

Non–FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety according to the applicable off‑label use policies. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) for the documentation standards required to consider coverage for off‑label uses.

Coverage under this clinical policy is subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance) and to applicable state and federal requirements and Health Plan administrative policies and procedures. This policy is a guide to medical necessity and does not guarantee payment.

Requests for uses that are not FDA‑approved will be evaluated against the Health Plan’s off‑label use criteria; if the requested indication is not supported by sufficient evidence per the off‑label policies, the use is considered not medically necessary. When seeking coverage for a non‑approved indication, provide documentation of efficacy and safety as specified in the referenced off‑label policies and be aware that coverage decisions remain subject to the member’s contract terms and administrative guidelines.

Product Codes, Thresholds and Key Values

Product availability/NDCNDC

NDC	Delayed release capsule: 4 mg

Proteinuria threshold — inv-08

Proteinuria thresholdProteinuria ≥ 0.5 g/day OR UPCR ≥ 0.8 g/g despite treatment with an ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) at maximally indicated doses

ACEi/ARB requirementProteinuria threshold applies despite at least 90 days of ACEi or ARB therapy at maximally indicated doses

Measurement optionsThreshold may be documented as 24-hour urine protein (g/day) or as urine protein-to-creatinine ratio (UPCR) in g/g

eGFR threshold — inv-09

eGFR minimumRecent (within the last 30 days) eGFR ≥ 35 mL/min/1.73 m2

Timing of testeGFR must be documented within 30 days of the request or assessment

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals and continuation/renewal approvals will be issued per the clinical criteria and stated approval durations in the policy (e.g., initial approval: 6 months for IgAN; continuation subject to total treatment duration limits and response criteria). Providers should obtain prior authorization from the member's Health Plan before initiating therapy.

Initial approval duration example: 6 months for Immunoglobulin A Nephropathy (see criteria).
Continuation approval duration: per continuation criteria — up to total treatment duration limits (e.g., do not exceed 38 weeks total where specified).

Denial Risk

Denial Triggers

Requests may be denied if submitted documentation does not support that the member meets all approval criteria, if the requested use is a non‑FDA indication not supported by sufficient off‑label evidence, or if dosing/age/diagnosis do not match policy criteria.

Background on Tarpeyo and Indication

Tarpeyo (targeted‑release budesonide) is an oral, targeted‑release corticosteroid formulated to deliver active drug to the distal ileum where mucosal immune activity implicated in immunoglobulin A nephropathy (IgAN) is modulated. It is indicated to reduce loss of kidney function in adults with primary IgAN at risk for progression. The dosing regimen supported by clinical trials and this policy is 16 mg once daily for 9 months followed by 8 mg once daily for a 2‑week taper; product is available as a delayed‑release 4 mg capsule. This policy aligns inclusion criteria with clinical trial entry and current guidance, including requirements for biopsy‑confirmed primary IgAN, adult age (≥ 18 years), proteinuria thresholds, concurrent ACEi/ARB therapy, and renal function limits.

Definitions and Abbreviations

UPCR definition — inv-19

UPCR abbreviationUPCR = urine protein-to-creatinine ratio

Use in criteriaUPCR is an accepted alternative to 24-hour urine protein for documenting proteinuria

UnitsReported as g protein per g creatinine (g/g)

eGFR definition — inv-20

eGFR abbreviationeGFR = estimated glomerular filtration rate

Role in policyUsed to document renal function eligibility (minimum eGFR threshold applies)

Common reporting units

Policy Summary

PayerCentene

PolicyBudesonide (Tarpeyo) for IgA Nephropathy

Policy CodePolicy CP.PHAR.572

Change TypeCriteria revised (1Q 2026)

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation (office notes, labs) showing biopsy-confirmed IgAN, proteinuria and eGFR results, and ACEi/ARB treatment history.

SourceLink

On This Page

Source of requirementRequirement added to align with clinical trial inclusion criteria (1Q 2023 review)

Denial may occur when documentation (office notes, labs, biopsy reports) is insufficient to demonstrate criteria are met.
Non‑FDA approved indications without adequate supporting evidence are not authorized (see off‑label policies referenced).

Denial Risk

Denial Risk When Coverage Terms Not Met

Coverage is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies; claims that do not comply with those documents or that fall outside policy limits may be denied.

Coverage decisions are governed by the member's evidence of coverage, certificate of coverage, policy, contract, and applicable state/federal requirements.
Providers submitting claims accept and are bound by the Health Plan's terms; where no contract exists, submission of services/claims implies agreement to terms.

Documentation Required

Required Documentation

Provider must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, pathology/biopsy reports, lab results (e.g., UPCR, proteinuria, eGFR), and consultation notes demonstrating that all approval criteria are met.

Office chart notes and nephrology consultation documenting diagnosis and treatment plan.
Biopsy report confirming primary IgA nephropathy and documentation ruling out secondary causes.
Recent labs: proteinuria measurement (g/day or UPCR), eGFR within required timeframe (e.g., within 30 days).

Documentation Required

Documentation and Claims Compliance

Follow the member's coverage documents and Health Plan administrative policies when submitting documentation and claims. Incomplete or inconsistent documentation may result in denial or payment delay.

Adhere to Health Plan‑level submission requirements and timelines.
Ensure claims reflect the approved diagnosis, dosing, and duration; retain supporting records for audit.

Step Therapy

Step Therapy / Redirection

Step therapy/redirection: follow the formulary and Health Plan redirection rules. Prior policy language requiring trial of an alternative systemic corticosteroid has been removed (1Q 2026); providers should follow current formulary and redirection guidance.

1Q 2026 update: requirement for one alternative systemic corticosteroid removed — follow current criteria instead.
If drug/formulary status changes, refer to the appropriate formulary/non‑formulary or off‑label policies as listed in the policy.

Note

Provider Action Note

Provider action: obtain prior authorization from the appropriate Health Plan and include all required documentation; check plan‑specific requirements and formularies prior to prescribing to avoid denials or delays.

Verify plan‑specific prior authorization processes and submit necessary clinical documentation.
Confirm dosing and total treatment duration do not exceed policy limits before submitting request.

IgAN definition — inv-21

IgAN abbreviationIgAN = immunoglobulin A nephropathy

Diagnostic requirementPolicy requires diagnosis of primary IgAN confirmed by biopsy

Exclusions to considerProvider must attest secondary causes of IgAN have been ruled out (e.g., IgA vasculitis, liver disease, infections, IBD, autoimmune disease)

Health Plan definition — inv-22

Health Plan definitionHealth Plan = a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Policy roleThis clinical policy provides guidance to assist coverage decisions and administering benefits for the Health Plan

Non-contractual natureThe clinical policy does not constitute a contract or guarantee of payment; coverage remains subject to the member's coverage documents and applicable laws/regulations