CurrentCentenePolicy N/A

Budesonide (Tarpeyo) for primary IgA nephropathy

Defines medical necessity criteria, initial and continuation approval conditions, dosing, exclusions, and prior authorization documentation requirements for Tarpeyo (targeted-release budesonide) for treatment of primary IgA nephropathy across Commercial, HIM, and Medicaid lines.

Policy Summary

PayerCentene

PolicyBudesonide (Tarpeyo) for primary IgA nephropathy

Policy CodePolicy N/A

Change TypeRevised/Added/Updated (2023-2024)

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member has met all approval criteria (diagnosis by biopsy, proteinuria, ACEi/ARB use, prior steroid trial, nephrologist involvement, age).

SourceLink

POLICY UPDATE CHANGES

1Q 2024 annual review clarified that 1 g/day is associated with proteinuria rather than UPCR and revised continuation approval duration to a total treatment duration of 38 weeks.

1Q 2023 annual review added requirement: recent (within the last 30 days) eGFR ≥ 35 mL/min/1.73 m2.

05.07.24: revised redirection to require one alternative systemic corticosteroid.

RT4: updated FDA approved indication per updated prescribing information (01.02.24 and referenced June 2024 prescribing info).

1Covered Indication (primary IgAN)

38wMaximum total treatment duration

16 mgMaximum daily dose

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>=1 g/dayProteinuria threshold

Coverage Summary

This policy covers Tarpeyo (targeted-release budesonide) for the FDA-approved indication to reduce loss of kidney function in adults with primary IgA nephropathy. Coverage is granted only when the specified medical necessity criteria are met. Key thresholds: age must be ≥ 18 years; proteinuria must be confirmed as ≥ 1 g/day (or UPCR ≥ 1 g/g as alternate evidence); the member must have been on an ACE inhibitor or ARB at up to maximally indicated doses for at least 90 days and Tarpeyo must be prescribed in combination with an ACEi or ARB; dose requested must not exceed 16 mg/day (4 capsules) administered as 16 mg daily for 9 months followed by 8 mg daily for a 2‑week taper. Continued therapy is limited to a maximum total treatment duration of 38 weeks.

Thresholds

Age>= 18 years

Proteinuria>= 1 g/day or UPCR >= 1 g/g

ACEi/ARB trial duration>= 90 days at up to maximally indicated doses

Maximum total treatment duration38 weeks

Dose16 mg (4 capsules) per day for 9 months then 8 mg (2 capsules) per day for 2-week taper

eGFR requirement (1Q2023)recent (within 30 days) eGFR >= 35 mL/min/1.73 m2

Initial Therapy Criteria — Primary IgA Nephropathy

Initial Approval Criteria - Primary IgA Nephropathy

Tarpeyo is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of primary IgAN confirmed by biopsy
Provider attestation that secondary causes of IgAN have been ruled out (eg, IgA vasculitis, liver cirrhosis, viral (hepatitis, HIV) and bacterial infection, inflammatory bowel disease, autoimmune disease such as lupus)
Prescribed by or in consultation with a nephrologist
Age >= 18 years
Proteinuria evidence (ONE of)

Continuation Therapy Criteria

Continued Therapy - Primary IgA Nephropathy

Member meets ONE of the following and ALL continuation requirements:

ALL of the following

ANY of the following
- Member is currently receiving medication via Centene benefit
- Member has previously met initial approval criteria
Member is responding positively as evidenced by a reduction in UPCR from baseline
Member has not received more than 38 weeks of treatment with Tarpeyo (total treatment duration limit)

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

ALL of the following

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation per off-label use policies is provided

Requests for Tarpeyo for non‑FDA indications will be denied unless sufficient documentation is provided per the off‑label use policies or redirection to formulary/non‑formulary policies applies. Refer to the applicable line‑of‑business policies: Commercial (CP.CPA.190 and CP.CPA.09 for off‑label), Health Insurance Marketplace (HIM.PA.33 / HIM.PA.103 and HIM.PA.154 for off‑label), and Medicaid (CP.PMN.255 / CP.PMN.16 and CP.PMN.53 for off‑label).

Applicable Codes

Product availability (NDC not provided)mixed

Delayed release capsule 4 mg

Product strength / formulation (Tarpeyo delayed-release capsule 4 mg)

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Requests must meet the listed initial or continuation criteria and will be authorized for the specified durations. Initial approvals are for 6 months. Continued therapy approvals are limited so total treatment does not exceed 38 weeks (treatment consists of 9 months of therapy followed by a 2‑week taper per dosing regimen).

Documentation Required

Submit supporting documentation

Submit office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria, including: biopsy confirmation of primary IgA nephropathy; documentation that secondary causes have been ruled out; evidence of proteinuria per policy thresholds; documentation of current ACEi or ARB therapy at maximally indicated doses for ≥90 days and that Tarpeyo is prescribed in combination with an ACEi/ARB; evidence of prior steroid trial (see steroid failure block); documentation of nephrologist involvement (prescribed by or in consultation with a nephrologist); and verification of patient age ≥18 years.

Clinical Evidence & References

Key reference: Tarpeyo Prescribing Information, Calliditas Therapeutics; June 2024. Clinical trials: NEFIGAN (Lancet 2017) and NEFIGARD (Kidney Int 2022) are cited as pivotal trials of targeted‑release budesonide in primary IgA nephropathy. Guideline: KDIGO 2021 Clinical Practice Guideline for Management of Glomerular Diseases is listed as a referenced guideline.

Background

Background: Tarpeyo is targeted‑release budesonide indicated to reduce the loss of kidney function in adults with primary IgA nephropathy. Coverage and dosing align with FDA prescribing information: 16 mg PO once daily for 9 months followed by an 8 mg daily dose for the last 2 weeks (taper). The policy requires that members be on and continue an ACE inhibitor or ARB (at maximally indicated doses) and documents that the member has failed one alternative systemic corticosteroid (e.g., methylprednisolone or prednisone) prior to Tarpeyo, unless contraindicated or adverse effects preclude use.

Scope & Dates

Policy Effective Date2022-03-01

Last Review Date2025-02-25

StatusCURRENT

Revision History

05.07.24revised

05.07.24: revised redirection to require one alternative systemic corticosteroid. (material)

1Q 2024revised

1Q 2024 annual review clarified that 1 g/day is associated with proteinuria rather than UPCR and revised continuation approval duration to a total treatment duration of 38 weeks. (material)

1Q 2023added

1Q 2023 annual review added requirement: recent (within the last 30 days) eGFR ≥ 35 mL/min/1.73 m2. (material)

Policy Summary

PayerCentene

PolicyBudesonide (Tarpeyo) for primary IgA nephropathy

Policy CodePolicy N/A

Change TypeRevised/Added/Updated (2023-2024)

Effective DateMar 1, 2022

Next Review Date

SourceLink

On This Page

Confirmation of proteinuria as evidenced by proteinuria >= 1 g/day

Confirmation of proteinuria as evidenced by urine protein-to-creatinine ratio (UPCR) >= 1 g/g

Member is currently receiving therapy with an ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) at up to maximally indicated doses for at least 90 days

Tarpeyo is prescribed in combination with an ACEi or ARB

Failure of one alternative systemic corticosteroid (e.g., methylprednisolone, prednisone) for at least 2 months, unless contraindicated or clinically significant adverse effects are experienced

Dose requested does not exceed 16 mg (4 capsules) per day for 9 months, followed by 8 mg (2 capsules) per day for 2 weeks (taper)

Initial Approval Criteria - Other diagnoses/indications

Coverage not authorized for other indications unless follow policy redirection:

ANY of the following

If drug is on formulary/PDL: follow no coverage criteria policy for relevant line of business (Commercial: CP.CPA.190; Health Insurance Marketplace: HIM.PA.33; Medicaid: CP.PMN.255)
If drug is NOT on formulary/PDL: follow non-formulary policy for relevant line of business (Commercial: CP.CPA.190; Health Insurance Marketplace: HIM.PA.103; Medicaid: CP.PMN.16)
If requested use is not listed in section III and initial criterion does not apply: refer to off-label use policy for relevant line of business (Commercial: CP.CPA.09; Health Insurance Marketplace: HIM.PA.154; Medicaid: CP.PMN.53)

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 2 weeks (taper)

Continued Therapy - Other diagnoses/indications

Refer to formulary/non-formulary/off-label redirection policies:

ANY of the following

For drugs on formulary/PDL follow no coverage criteria policy for relevant line of business (Commercial: CP.CPA.190; HIM: HIM.PA.33; Medicaid: CP.PMN.255)
For drugs not on formulary/PDL follow non-formulary policy for relevant line of business (Commercial: CP.CPA.190; HIM: HIM.PA.103; Medicaid: CP.PMN.16)
If use not listed and initial criteria don't apply, refer to off-label use policy (Commercial: CP.CPA.09; HIM: HIM.PA.154; Medicaid: CP.PMN.53)

Documentation Required

Evidence of steroid failure

Document that one alternative systemic corticosteroid (for example, methylprednisolone or prednisone) was tried and failed for at least 2 months, unless use was contraindicated or clinically significant adverse effects occurred. Provide chart notes or other records showing the agent, dose/duration (≥2 months), and reason for discontinuation or failure.

Billing Rule

Dose limits enforcement

Dose requests must conform to the FDA‑aligned regimen: 16 mg per day (4 capsules of the 4 mg delayed‑release formulation) once daily for 9 months, followed by an 8 mg per day dose for the final 2‑week taper. Requests for dose increases must not exceed these dose limits.

Denial Risk

Exclusion for non-FDA indications without documentation

Coverage for non‑FDA approved (off‑label) indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided in accordance with the applicable off‑label use policies, or the request is redirected to the relevant formulary/non‑formulary policy as specified.

01.02.24 / June 2024 (RT4)updatedLatest

RT4 / June 2024: updated FDA approved indication per updated prescribing information (non-material)