CurrentBlue Cross Blue Shield - IowaPolicy 05.04.61

Tarpeyo (budesonide DR) — prior authorization and medical necessity criteria for primary IgA nephropathy

Covers prior authorization and medical necessity criteria for Tarpeyo (budesonide delayed release) to reduce loss of kidney function in adults with primary IgA nephropathy; applies to Wellmark/Blue Cross Blue Shield members governed by the payer's benefit contracts.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTarpeyo (budesonide DR) — coverage criteria

Policy CodePolicy 05.04.61

Change TypeAdministrative — no material clinical changes

Effective DateMar 10, 2026

Next Review Date

Key ActionSubmit prior authorization with kidney biopsy confirming primary IgAN and documentation of proteinuria ≥0.5 g/day and eGFR ≥35 mL/min/1.73 m2.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10 monthsAuth duration (initial)

120 caps/30dQuantity limit

40 weeksLifetime duration limit

>=35Minimum eGFR

>=0.5 g/dayProteinuria threshold

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Coverage Criteria for Tarpeyo (budesonide DR)

Criteria for Approval

Authorization of 10 months may be granted when ALL of the following are met:

Initial Approval Criteria: A. Member has a diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy

Required documentation: kidney biopsy confirming primary IgAN (see clinical documentation).

B. Member is 18 years of age or older

C. Member is at risk of rapid disease progression defined by proteinuria greater than or equal to 0.5 g/day>= 0.5 g/day

Laboratory report or chart note documenting proteinuria required.

D. Member's estimated glomerular filtration rate (eGFR) is equal to or greater than 35 mL/min per 1.73 m2>= 35 mL/min/1.73 m2

E. Member is currently receiving a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor therapy (e.g., ACEI or ARB) for at least 3 months and will continue RAS inhibitor therapy, or has an intolerance or contraindication to RAS inhibitors

Prescriber must document duration of RAS therapy or reason for intolerance/contraindication.

F. Prescribed dose does not exceed 16 mg (4 capsules) per day for 9 months followed by 8 mg (2 capsules) per day for two weeks

Authorization duration 10 months; quantity limit 120 capsules per 30 days; lifetime duration limit 40 weeks.

G. Tarpeyo will not be used in combination with Filspari (sparsentan), Vanrafia (atrasentan), Voyxact (sibeprenlimab-szsi), or Fabhalta (iptacopan)

Concomitant use with listed agents is prohibited.

H. Member has not received more than 40 weeks of treatment with Tarpeyo (safety and efficacy beyond 40 weeks not established)

Use of Tarpeyo in combination with the following agents is prohibited: Filspari (sparsentan), Vanrafia (atrasentan), Voyxact (sibeprenlimab‑szsi), and Fabhalta (iptacopan).

Tarpeyo is considered not medically necessary for members who do not meet the specified coverage criteria. Refer to the Criteria for Approval for required elements such as biopsy‑confirmed primary IgAN, age ≥18 years, proteinuria ≥0.5 g/day, eGFR ≥35 mL/min/1.73 m2, required RAS inhibitor therapy (or documented intolerance/contraindication), dosing limits, and the 40‑week lifetime treatment limit.

Coding and Key Clinical Thresholds

Provider services coding guidancemixed

No codes listed

Proteinuria threshold

Proteinuria threshold>= 0.5 g/day (risk of rapid disease progression)

Supporting documentationLaboratory report or chart note demonstrating proteinuria >= 0.5 g/day required for PA

Role in approval criteriaOne of the required ALL criteria for authorization of 10 months

eGFR threshold

eGFR threshold>= 35 mL/min/1.73 m2

Eligibility impactMember's eGFR must meet or exceed this value to qualify for initial authorization

Relation to duration limits

Prior Authorization, Documentation, and Prescribing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tarpeyo (targeted therapy for IgA nephropathy). Approval may be granted for up to 10 months when all clinical criteria are met.

Authorization duration: up to 10 months when criteria are met
Quantity/Duration limits: 120 capsules per 30 days (4 capsules/day); lifetime duration limit 40 weeks

Denial Risk

Denial Risk if Criteria Not Met

Tarpeyo will be considered not medically necessary and will be denied when the listed approval criteria are not satisfied. Examples of denial triggers include: no kidney biopsy confirming primary IgA nephropathy, member younger than 18 years, proteinuria <0.5 g/day, eGFR <35 mL/min/1.73 m2, lack of required RAS therapy history or intolerance documentation, dosing beyond policy limits, prior exposure exceeding 40 weeks, or concomitant use with listed contraindicated agents.

Background

Tarpeyo is an oral targeted‑release formulation of budesonide designed to deliver drug to the ileocecal region to act on gut‑associated lymphoid tissue implicated in primary IgA nephropathy. It is indicated to reduce loss of kidney function in adults with primary IgAN who are at risk for progression. Clinical use is constrained by specific eligibility and dosing criteria in order to balance potential benefit (reductions in proteinuria and preservation of eGFR in trials) against risks; therefore prescribing and monitoring requirements and lifetime treatment limits are defined in the criteria for approval.

Definitions

Primary IgA nephropathy (IgAN)

DefinitionPrimary IgA nephropathy (IgAN) is a glomerular disease characterized by deposition of IgA1-containing immune complexes in the kidney; Tarpeyo is indicated to reduce loss of kidney function in adults with primary IgAN who are at risk for progression.

Diagnostic requirementDiagnosis must be confirmed by kidney biopsy to meet prior authorization criteria.

Clinical rationaleTarpeyo targets gut-associated lymphoid tissue (Peyer’s patches) to reduce production of GdIgA1 implicated in IgAN pathogenesis.

Related PA documentationSubmission of kidney biopsy report is required to initiate prior authorization review.