CurrentColorado Rocky Mountain Health PlansPolicy N/A

Vanrafia (atrasentan) prior authorization for IgA nephropathy

Defines prior authorization and medical necessity criteria for coverage of Vanrafia (atrasentan) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid progression; applies to prescriptions requiring UnitedHealthcare Pharmacy Clinical Pharmacy Programs review.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVanrafia (atrasentan) prior authorization for IgA nephropathy

Policy CodePolicy N/A

Change TypeNew policy (prior authorization program)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating biopsy‑confirmed primary IgAN, risk of progression (e.g., UPCR), eGFR ≥30, ACEi/ARB optimization, and nephrology involvement.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Vanrafia (atrasentan) established with clinical criteria for initial authorization and reauthorization.

UPCR ≥ 1.5typical proteinuria threshold

eGFR ≥ 30minimum renal function

12 moauthorization duration

6/2025P&T approval

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Coverage Criteria for Vanrafia (atrasentan)

Initial Authorization

Covered when ALL of the following are met:

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy.
Patient is at risk of disease progression.
Used to slow kidney function decline.
Used to reduce proteinuria.
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2.≥ 30 mL/min/1.73 m2
Both of the following:
- Patient is on a maximized stable dose of either a maximally tolerated angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril) OR a maximally tolerated angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan) prior to initiating therapy.
- Use of endothelin receptor antagonists (ERAs) (e.g., bosentan, ambrisentan, macitentan or branded examples such as Letairis, Opsumit, Tracleer) will be discontinued prior to initiating treatment.
History of failure, contraindication, or intolerance to a 30-day trial of a glucocorticoid (e.g., methylprednisolone, prednisone).
Prescribed by or in consultation with a nephrologist.

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Initial Authorization

Reauthorization

Reauthorization covered when the following is met:

Documentation of positive clinical response demonstrated by a reduction in proteinuria.reduction in proteinuria
Approval period: 12 months (subject to state mandates and member benefit plan).

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Reauthorization

This policy defines coverage for Vanrafia (atrasentan) specifically to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy who are at risk of rapid disease progression (the indication references UPCR generally ≥ 1.5 g/g). Eligibility requires meeting all clinical criteria in the Initial Authorization set, including a baseline renal function of at least eGFR ≥ 30 mL/min/1.73 m2, documented optimization with a maximized ACE inhibitor or ARB (unless contraindicated), and discontinuation of other endothelin receptor antagonists prior to initiating Vanrafia. Initial approvals are issued per the policy when all listed conditions are satisfied; reauthorization requires documentation of a positive clinical response evidenced by a reduction in proteinuria.

Use of Vanrafia is limited to the FDA‑labeled accelerated approval indication: reduction of proteinuria in adults with primary IgAN at risk of rapid progression. The policy does not describe coverage for other indications. Concurrent therapy with other endothelin receptor antagonists (e.g., bosentan, macitentan, ambrisentan) is effectively excluded because ERAs must be discontinued prior to initiating Vanrafia. A trial and current use of a maximized stable ACE inhibitor or ARB is required unless there is documented intolerance or contraindication. Vanrafia should be prescribed or used in consultation with a nephrologist per the coverage criteria.

Coding and Clinical Thresholds

Diagnosis codes referenced for claim logicICD-10

ICD-10 (general)

Diagnosis codes may be used for automated approvals; specific ICD-10 codes not listed in document.

inv-06: UPCR — key-value displaying the urine protein-to-creatinine ratio threshold

UPCR threshold≥ 1.5 g/g (urine protein-to-creatinine ratio) — threshold referenced in the indication for adults with primary IgAN at risk of rapid progression

ContextReferenced as the general threshold indicating patients with IgAN are at risk of rapid disease progression

Use in criteriaUsed to establish 'at risk of disease progression' for initial authorization of Vanrafia

inv-07: eGFR — key-value showing minimum renal function threshold for eligibility

eGFR minimum for eligibility≥ 30 mL/min/1.73 m2 (estimated glomerular filtration rate) — required for initial authorization

Placement in criteriaListed as a required clinical condition (Initial Authorization condition 'e')

ImplicationeGFR below this threshold may trigger denial of authorization

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vanrafia. Submit a prior authorization request and include all required clinical documentation; approvals are time-limited (see Reauthorization). Operationally, requests must demonstrate that initial-therapy criteria are met prior to approval.

Prior authorization required for Vanrafia
Authorization issued for 12 months

Step Therapy

Background Step Therapy

Prior to initiating Vanrafia, patients must have trialed and been maximized on an ACE inhibitor or an ARB (or have a documented contraindication/intolerance). The ACE inhibitor or ARB must be at a maximally tolerated stable dose. If an ERA is being used, it must be discontinued before starting Vanrafia.

Must trial/maximize ACE inhibitor (e.g., captopril, enalapril) OR maximally tolerated ARB (e.g., candesartan, valsartan)
Discontinue endothelin receptor antagonists (e.g., bosentan, ambrisentan, macitentan) prior to initiation
Documented failure, contraindication, or intolerance to ACE/ARB should be included if applicable

Documentation Required

Required Medical Record Documentation

Include the following medical record documentation with the prior authorization request to support medical necessity: renal biopsy confirming primary IgA nephropathy, baseline and follow-up urine protein-to-creatinine ratio (UPCR) showing proteinuria and response, baseline estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2, prior treatment history (including ACE/ARB dosing and duration, ERA discontinuation, and a 30‑day glucocorticoid trial or reason for not using), and documentation of nephrology involvement (prescriber or consult).

Renal biopsy confirming primary IgA nephropathy (IgAN)
Baseline eGFR (must be ≥ 30 mL/min/1.73 m2)
Baseline UPCR and follow-up UPCRs to document response
Documentation of maximized ACE inhibitor or ARB (dosing and duration) or documented contraindication/intolerance
Documentation of ERA discontinuation if applicable
Documentation of 30‑day glucocorticoid trial or reason for failure/contraindication/intolerance
Prescriber is a nephrologist or documentation of nephrology consultation

Denial Risk

Triggers for Denial / High-Risk Conditions

Claims or authorizations may be denied if required criteria or documentation are missing or if the patient does not meet clinical thresholds. Common denial triggers include absence of biopsy-confirmed primary IgAN, insufficient evidence of risk for progression or indication to slow kidney function decline, eGFR < 30 mL/min/1.73 m2, lack of documentation of maximized ACE inhibitor or ARB (or no documented contraindication), ongoing use of an endothelin receptor antagonist without discontinuation, no documentation of prior 30‑day glucocorticoid trial or rationale for omission, and no nephrology involvement.

No renal biopsy confirming primary IgAN
Insufficient evidence patient is at risk of progression or lacks indication to slow decline/reduce proteinuria
Baseline eGFR < 30 mL/min/1.73 m2
No documentation of maximized ACE inhibitor or ARB and no documented contraindication/intolerance
Endothelin receptor antagonist not discontinued prior to initiation
No documentation of 30‑day glucocorticoid trial or reason for not using
Prescriber not a nephrologist and no nephrology consult provided

Definitions and Clinical Terms

inv-13: Primary IgAN (biopsy-confirmed) — definition of biopsy-confirmed primary immunoglobulin A nephropathy

DefinitionPrimary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy — diagnosis must be confirmed by renal biopsy for initial authorization

Role in authorizationBiopsy confirmation is a required condition in the Initial Authorization criteria (condition 'a')

Documentation requirementMedical record must include renal biopsy confirming primary IgAN per required documentation list

inv-14: At risk of rapid progression (UPCR threshold) — define UPCR threshold generally used to indicate risk

UPCR level indicating riskGenerally ≥ 1.5 g/g (urine protein-to-creatinine ratio) — used to indicate patients with IgAN are at risk of rapid progression

Source languageThreshold cited in the product indication describing adults with primary IgAN at risk of rapid disease progression

Use in policy logicApplied to determine 'at risk of disease progression' for initial authorization of Vanrafia

OpenPayer

Vanrafia (atrasentan) prior authorization for IgA nephropathy

Coverage Criteria for Vanrafia (atrasentan)

Coding and Clinical Thresholds

Provider Requirements and Authorization Process

Background on Atrasentan (Vanrafia)

Definitions and Clinical Terms

Policy Revision History