CurrentBlue Cross Blue Shield - IowaPolicy N/A

Vanrafia (atrasentan) — Coverage Criteria for Primary IgA Nephropathy

Defines prior authorization, coverage criteria, dosing limits, and documentation requirements for Vanrafia (atrasentan) to reduce proteinuria in adults with primary IgA nephropathy for Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVanrafia (atrasentan) — Coverage Criteria for Primary IgA Nephropathy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 10, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation: kidney biopsy confirming primary IgAN, UPCR ≥1.5 g/g, eGFR ≥30 mL/min/1.73 m2, and trial of sparsentan unless intolerant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1.5 g/gUPCR threshold

≥30eGFR minimum

0.75 mgFDA dosing

30 tabQuantity limit

≥18Adult-only

Coverage Criteria for Vanrafia (atrasentan)

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVanrafia (atrasentan) — Coverage Criteria for Primary IgA Nephropathy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 10, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation: kidney biopsy confirming primary IgAN, UPCR ≥1.5 g/g, eGFR ≥30 mL/min/1.73 m2, and trial of sparsentan unless intolerant.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met for initial therapy:

Initial Approval - All criteria: 1. Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy; 2. Age ≥ 18 years; 3. At risk for rapid disease progression defined by UPCR ≥ 1.5 g/g; 4. eGFR ≥ 30 mL/min per 1.73 m2; 5. Received a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor therapy (ACE inhibitor or ARB) for ≥ 3 months prior to initiation, or has documented intolerance/contraindication to RAS inhibitors; 6. Tried and failed Filspari (sparsentan) unless intolerant or contraindicated; 7. Vanrafia will not be used in combination with Tarpeyo (budesonide delayed release), Fabhalta (iptacopan), Filspari (sparsentan), or Voyxact (sibeprenlimab-szsi); 8. Dosing and quantity limits are within FDA labeling (0.75 mg once daily; standard limit 30 tablets per 30 days).

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation Approval - All criteria: 1. No evidence of unacceptable toxicity or disease progression while on the current regimen; 2. Member is experiencing clinical benefit from Vanrafia demonstrated by either decreased proteinuria from baseline or a decrease in UPCR from baseline; required documentation provided via chart notes, medical records, or laboratory values.

Members who do not meet the criteria specified in this policy are considered to have Vanrafia (atrasentan) not medically necessary. Members currently receiving Vanrafia as samples or through the manufacturer’s patient assistance program must still meet the policy’s initial approval criteria to continue therapy.

Vanrafia (atrasentan) is considered not medically necessary for members who do not meet the criteria set forth in this policy. This applies regardless of how the member initially received the drug (including samples or patient assistance), and such members must satisfy the initial approval requirements to be eligible for coverage.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vanrafia (atrasentan) for IgAN. Initial requests must include documentation demonstrating biopsy-proven primary IgA nephropathy and that the member meets baseline clinical thresholds; continuation requests must show ongoing benefit and absence of unacceptable toxicity.

Prior authorization required for Vanrafia (atrasentan) for treatment of primary IgAN
Quantity limit: 30 tablets per 30 days; FDA dosing: 0.75 mg orally once daily

Prior Authorization

Initial Authorization Criteria (ALL must be met)

Initial approval will be considered only when ALL of the following are provided and met.

Diagnosis of primary IgA nephropathy confirmed by kidney biopsy
Age ≥ 18 years
Urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
Stable dose of maximally tolerated renin‑angiotensin system (RAS) inhibitor therapy for ≥ 3 months prior to initiation, or documentation of intolerance/contraindication to RAS inhibitors
Trial and failure of Filspari (sparsentan) unless intolerant or contraindicated
Requested medication will not be used in combination with Tarpeyo (budesonide DR), Fabhalta (iptacopan), Filspari (sparsentan), or Voyxact (sibeprenlimab-szsi)

Prior Authorization

Continuation Criteria (ALL must be met)

Continuation of therapy will be approved only when ALL of the following are documented.

No evidence of unacceptable toxicity or disease progression while on Vanrafia (atrasentan)
Clinical benefit demonstrated by either: (a) decreased levels of proteinuria from baseline, or (b) decrease in UPCR from baseline

Documentation Required

Required Documentation

Provide the following documentation to initiate and support prior authorization reviews. Incomplete documentation may result in delay or denial.

Initial requests: kidney biopsy report confirming diagnosis of primary IgA nephropathy; chart notes, medical records, or laboratory values showing UPCR ≥ 1.5 g/g and other relevant baseline data (age, eGFR)
Continuation/renewal requests: chart notes, medical records, or laboratory values demonstrating clinical response (decreased proteinuria or decreased UPCR from baseline) and absence of unacceptable toxicity
If claiming intolerance/contraindication to RAS inhibitors or Filspari (sparsentan), submit documentation supporting intolerance or contraindication and prior treatment history

Denial Risk

Denial for Not Meeting Criteria

Requests that do not meet the stated criteria or lack required documentation will be considered not medically necessary and will be denied.

Denial examples: absence of biopsy-confirmed primary IgAN; UPCR < 1.5 g/g at baseline; eGFR < 30 mL/min/1.73 m2; no prior trial of RAS inhibitors without documented intolerance/contraindication; no trial of Filspari (sparsentan) without documented intolerance/contraindication; concurrent use with disallowed agents
Members receiving samples or through manufacturer assistance programs must meet initial approval criteria to continue coverage

Key Definitions and Treatment Preconditions

inv-13: At risk for rapid disease progression — defined as UPCR ≥ 1.5 g/g

DefinitionAt risk for rapid disease progression is generally defined as UPCR ≥ 1.5 g/g

Regulatory basisThis threshold is cited in the FDA‑approved indication for Vanrafia

Use in policyServes as a required criterion for initial coverage authorization

inv-14: Maximally tolerated RAS inhibitor therapy — stable ACE inhibitor or ARB dose for ≥ 3 months prior to initiation or documented intolerance/contraindication

Required definitionMaximally tolerated RAS inhibitor therapy = stable dose of ACE inhibitor or ARB for ≥ 3 months prior to initiation

ExceptionOr documented intolerance or contraindication to RAS inhibitors

Policy rolePrior stable RAS therapy (or intolerance) is required for initial approval of Vanrafia

OpenPayer

Vanrafia (atrasentan) — Coverage Criteria for Primary IgA Nephropathy

Coverage Criteria for Vanrafia (atrasentan)

Procedures, Codes, and Key Thresholds

Prior Authorization, Documentation, and Provider Requirements

Background on Vanrafia (atrasentan)

Key Definitions and Treatment Preconditions