CurrentAvMedPolicy N/A

Vanrafia (atrasentan) prior authorization for IgA nephropathy

Defines pharmacy prior authorization and step-edit requirements for Vanrafia (atrasentan) for members with biopsy-proven primary IgA nephropathy; applies to AvMed members and prescribing providers submitting specialty pharmacy requests.

Policy Summary

PayerAvMed

PolicyVanrafia (atrasentan) prior authorization for IgA nephropathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed pharmacy prior authorization form with prescriber signature and supporting documentation (labs, diagnostics, chart notes) via fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+min age

0.75 mgdose

1/dayqty limit

9 moinit auth

12 morenewal

Coverage Criteria

Initial Therapy

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

Initial Authorization Criteria: Member is >= 18 years of age; Provider is a nephrologist; Diagnosis of biopsy-proven, primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression; Member is currently established on a stable and maximally tolerated dose of a RAAS inhibitor (ACE inhibitor or ARB) for >= 90 days (verification by chart notes and/or pharmacy paid claims required); Current lab results within the last 30 days documenting total urine protein >= 1 g/day OR urine protein-to-creatinine ratio >= 1.0 g/g AND eGFR >= 30 mL/min/1.73 m2; Member is NOT currently receiving dialysis and has NOT undergone a kidney transplant; Provider attests pregnancy testing will be completed prior to initiation and member will use effective contraception if of child-bearing potential; Member has had an unsuccessful 3-month trial of oral generic budesonide EC capsules (documentation required) OR has intolerance/hypersensitivity/FDA-labeled contraindication to budesonide that is not expected to occur with Vanrafia (documentation required).see thresholds

Initial authorization duration 9 months

Continuation Therapy

Reauthorization requirements — all that apply must be met:

Policy Summary

PayerAvMed

PolicyVanrafia (atrasentan) prior authorization for IgA nephropathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed pharmacy prior authorization form with prescriber signature and supporting documentation (labs, diagnostics, chart notes) via fax to 1-305-671-0200.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Reauthorization Criteria: Member continues to meet all initial authorization criteria; Demonstrated reduction in UPCR or proteinuria from baseline after initial approval, and reduction or stabilization after subsequent approvals (current lab test results must be submitted); Current lab results within the last 30 days documenting eGFR >= 30 mL/min/1.73 m2; Member has NOT experienced any treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury).see thresholds

Reauthorization duration 12 months

Concomitant therapies

Concomitant therapy exclusion: Member must NOT be using concomitant therapy with Tarpeyo, Filspari, Fabhalta, Vanrafia, Voyxact, or other complement inhibitor therapies (e.g., Empaveli, Soliris, Ultomiris, Voydeya).

Concomitant use is disallowed

Members receiving concomitant complement-targeting therapies are excluded from approval. Specifically, concomitant use of Tarpeyo, Filspari, Fabhalta, Vanrafia, Voyxact, or other complement inhibitor therapies (for example, Empaveli, Soliris, Ultomiris, or Voydeya) is not allowed and will preclude coverage.

Requests that lack required documentation or that fail to meet numeric thresholds are at high risk for denial. Providers must submit current lab results (within the last 30 days) demonstrating total urine protein ≥ 1 g/day OR UPCR ≥ 1.0 g/g and eGFR ≥ 30 mL/min/1.73 m2; failure to provide these will jeopardize approval. Members on dialysis, with prior kidney transplant, or with eGFR < 30 mL/min/1.73 m2 do not meet medical necessity per criteria. Additionally, incomplete, incorrect, or illegible request information, missing chart notes (including confirmation of ≥90 days on a maximally tolerated RAAS inhibitor), or absence of required documentation of a failed 3‑month trial of budesonide EC (or documentation of intolerance/contraindication) may delay or result in denial.

Initial Therapy

Initial authorization (9 months) criteria:

Initial: Adult (>=18 years), nephrologist prescriber; Biopsy-proven primary IgAN at risk of rapid progression; On stable, maximally tolerated RAAS inhibitor (ACE inhibitor or ARB) for >= 90 days (verified by chart notes and/or pharmacy paid claims); Total urine protein >= 1 g/day OR UPCR >= 1.0 g/g; eGFR >= 30 mL/min/1.73 m2; Not receiving dialysis and no prior kidney transplant; Pregnancy testing and effective contraception required for those with child-bearing potential; Prior unsuccessful 3-month trial of oral generic budesonide EC capsules (documentation required) OR intolerance/hypersensitivity/contraindication to budesonide (documentation required).see thresholds

Initial authorization duration 9 months; Dose: 0.75 mg once daily; Quantity limit: 1 tablet/day

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization (12 months) requires:

Reauthorization: Continued fulfillment of all initial authorization criteria; Documented reduction in UPCR or proteinuria from baseline after initial approval and reduction or stabilization thereafter (current lab results must be submitted); Current lab results within the last 30 days documenting eGFR >= 30 mL/min/1.73 m2; No treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury).see thresholds

Reauthorization period 12 months

Coding and Clinical Thresholds

Form fields / unspecifiedmixed

N/A	No specific CPT/HCPCS/NDC codes listed on form; ICD code field present for submitter to provide

inv-07: eGFR — clinical threshold for eligibility

eGFR threshold>= 30 mL/min/1.73 m2

When measuredCurrent lab test results within the last 30 days must be submitted

Applies toRequired for both initial authorization and reauthorization

inv-08: Proteinuria — urine protein / UPCR threshold details

Proteinuria thresholdTotal urine protein >= 1 g/day OR urine protein-to-creatinine ratio (UPCR) >= 1.0 g/g

When measuredCurrent lab test results taken within the last 30 days must be submitted to document proteinuria/UPCR

Requirement timingRequired for initial authorization and used to assess response for reauthorization (reduction or stabilization required)

inv-09: RAAS therapy duration — required duration (>= 90 days)

Required duration on RAAS therapy>= 90 days (stable and maximally tolerated dose)

DocumentationVerified by chart notes and/or pharmacy paid claims

Included agentsACE inhibitors or ARBs (renin-angiotensin-aldosterone system inhibitors)

Step Therapy Requirements

Step	Requirement
1	Member has had an unsuccessful 3-month trial of oral generic budesonide EC capsules (must submit chart notes or lab test results confirming therapy failure)
1	Member has an intolerance or hypersensitivity to oral generic budesonide EC capsules or an FDA‑labeled contraindication to oral generic budesonide EC capsules that is not expected to occur with Vanrafia (documentation of intolerance or hypersensitivity must be submitted)

Quantity Limits

inv-20: Vanrafia (atrasentan) — quantity limit (1)

Quantity limit1 tablet per day

Recommended dose0.75 mg once daily

FormulationOral tablet

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization and Submission

Prior authorization is required for this medication. Submit completed prior authorization/step-edit request forms with the prescribing physician’s original signature (preprinted stamps not valid). Fax requests to 1-305-671-0200. Incomplete, incorrect, or illegible information (including missing phone/fax numbers) may delay processing or result in denial.

Fax: 1-305-671-0200
Prescriber signature required (original; preprinted stamps not valid)
Medication provisioned via Specialty Pharmacy - Proprium Rx
Use of samples to initiate therapy does NOT meet step edit/prior authorization criteria

Step Therapy

Step Requirement vs Budesonide

A trial of oral generic budesonide EC capsules for 3 months is required prior to approval unless the member has documented intolerance/hypersensitivity or an FDA-labeled contraindication to budesonide that would not be expected with the requested agent. Documentation of trial failure or intolerance/hypersensitivity must be provided.

Required: unsuccessful 3-month trial of oral generic budesonide EC capsules (submit chart notes or lab results confirming failure)
Alternative: documented intolerance or hypersensitivity to budesonide, or FDA contraindication not expected to occur with requested agent (submit documentation)

Documentation Required

Required Documentation

All clinical documentation supporting the request must be submitted. Authorization may be delayed or denied if documentation is incomplete. For initial requests provide chart notes/pharmacy claims demonstrating prior therapies and the following supporting data (most recent labs within 30 days unless otherwise noted):

Diagnosis documentation: biopsy-proven primary IgA nephropathy
Laboratory results within last 30 days: total urine protein ≥1 g/day OR urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g
Laboratory results within last 30 days: eGFR ≥30 mL/min/1.73 m2
Proof of member NOT on dialysis and no history of kidney transplant
Documentation of stable, maximally tolerated RAAS inhibitor (ACE inhibitor or ARB) therapy for ≥90 days (chart notes and/or paid pharmacy claims)
Pregnancy test documentation for members with child-bearing potential and plan for effective contraception prior to and during treatment
Documentation of prior budesonide trial or intolerance/hypersensitivity as applicable
For reauthorization: current lab results within last 30 days showing reduction or stabilization in UPCR/proteinuria from baseline and eGFR ≥30 mL/min/1.73 m2, plus evidence of no treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury)

Denial Risk

Documentation and Completeness Requirements

Incomplete, incorrect, or illegible requests and missing supporting documentation (labs, diagnostics, chart notes, signature) can delay the authorization process or result in denial. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Authorization may be delayed if documentation is incomplete or illegible
Previous therapies will be verified via pharmacy paid claims or chart notes
Ensure phone and fax numbers are provided and legible on the request form

Site of Care

Note

Specialty pharmacy provisioning (Proprium Rx)

Vanrafia is dispensed via specialty pharmacy — medication is provided by Proprium Rx; coordinate submission and distribution through the specialty pharmacy channel.

Medication provided by Specialty Pharmacy - Proprium Rx

Background

Vanrafia (atrasentan) is requested for treatment of adults with biopsy-proven primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The policy requires members be managed by a nephrologist, be ≥18 years old, and be on a stable, maximally tolerated RAAS inhibitor (ACE inhibitor or ARB) for ≥90 days. Baseline laboratory documentation within the prior 30 days is required showing qualifying proteinuria (total urine protein ≥ 1 g/day or UPCR ≥ 1.0 g/g) and eGFR ≥ 30 mL/min/1.73 m2. Initial approvals are for 9 months with reauthorization (12 months) contingent on continued criteria fulfillment and evidence of reduction or stabilization in proteinuria.

Definitions

inv-15: IgAN — biopsy-proven, primary immunoglobulin A nephropathy

DefinitionBiopsy-proven, primary immunoglobulin A nephropathy (IgAN)

PopulationAdults (>=18 years) with IgAN at risk of rapid disease progression

Documentation requiredBiopsy confirmation must be provided with prior authorization request

inv-16: RAAS inhibitor — includes ACE inhibitors or ARBs

DefinitionRenin-angiotensin-aldosterone system (RAAS) inhibitor includes ACE inhibitors or ARBs

Therapy requirementMember must be on a stable and maximally tolerated RAAS inhibitor for >=90 days prior to initiation

VerificationDuration verified by chart notes and/or pharmacy paid claims