ModifiedQualChoicePolicy CP.PHAR.727

Atrasentan (Vanrafia) for IgA nephropathy

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Defines medical necessity criteria, prior authorization and continuation requirements for Vanrafia (atrasentan) primarily for adults with immunoglobulin A nephropathy (IgAN) with specified proteinuria and renal function, and applies to the payer's Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerQualChoice

PolicyAtrasentan (Vanrafia) for IgA nephropathy

Policy CodePolicy CP.PHAR.727

Change TypeCriteria and duration revisions

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation showing biopsy-confirmed IgAN, proteinuria ≥ 0.5 g/day (or UPCR ≥ 1.5 g/g), eGFR ≥ 30 mL/min/1.73 m2, and evidence of RAAS inhibitor therapy for ≥12 weeks.

SourceLink

POLICY UPDATE CHANGES

Revised proteinuria criterion from 1 g/day to 0.5 g/day per updated 2025 KDIGO guidelines.

Extended initial approval duration from 6 to 12 months for this maintenance medication.

Added ICHRA line of business.

0.5 g/dayProteinuria threshold

≥30eGFR requirement

0.75 mgMax daily dose

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ModifiedQualChoicePolicy CP.PHAR.727

Atrasentan (Vanrafia) for IgA nephropathy

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Policy Summary

PayerQualChoice

PolicyAtrasentan (Vanrafia) for IgA nephropathy

Policy CodePolicy CP.PHAR.727

Change TypeCriteria and duration revisions

Effective DateJun 1, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Revised proteinuria criterion from 1 g/day to 0.5 g/day per updated 2025 KDIGO guidelines.

Extended initial approval duration from 6 to 12 months for this maintenance medication.

Added ICHRA line of business.

0.5 g/dayProteinuria threshold

≥30eGFR requirement

0.75 mgMax daily dose

12 moApproval duration

Coverage Criteria for Atrasentan (Vanrafia)

Initial Therapy (Immunoglobulin A Nephropathy)

Covered when ALL of the following are met:

Initial Approval - IgAN: 1. Diagnosis of IgAN confirmed via kidney biopsy; 2. Prescribed by or in consultation with a nephrologist; 3. Age ≥ 18 years; 4. Documentation of both: a) Proteinuria of ≥ 0.5 g/day or UPCR ≥ 1.5 g/g; b) eGFR ≥ 30 mL/min/1.73 m2; 5. Member is currently receiving therapy with a RAAS inhibitor at up to maximally tolerated doses for at least 12 weeks unless contraindicated or clinically significant adverse effects are experienced; 6. Vanrafia is prescribed in combination with a RAAS inhibitor unless contraindicated or clinically significant adverse effects are experienced; 7. Dose does not exceed 0.75 mg (1 tablet) per day.see individual nodes

Approval duration: 12 months

Continuation Therapy (Immunoglobulin A Nephropathy)

Continued therapy coverage requires:

Continued Therapy - IgAN: 1. Member meets one of: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by one of: a) decrease in UPCR from baseline; b) reduction in total urine protein per day from baseline; 3. If request is for a dose increase, new dose does not exceed 0.75 mg (1 tablet) per day.response documented vs baseline

Approval duration: 12 months

Other Diagnoses/Indications

Other/Off-label uses:

Other indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow the applicable formulary or non‑formulary policy for the member's line of business as specified (see policy cross‑references). 2. If the requested use is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, CP.PMN.53 for Medicaid).referenced policies apply

See policy cross‑references

Contraindications include pregnancy and hypersensitivity. The product carries a boxed warning for embryo‑fetal toxicity, and use in pregnant persons is contraindicated. Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless sufficient documentation of efficacy and safety is provided in accordance with applicable off‑label use policies.

Coverage and administration of benefits for requests are subject to all terms, conditions, exclusions, and limitations of the applicable coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as state and federal requirements and Health Plan administrative policies and procedures. This policy is a guide to medical necessity and does not constitute a guarantee of payment.

Use of this product for non‑FDA approved (off‑label) indications that are not specifically addressed in this policy is not authorized as medically necessary unless the request includes sufficient clinical documentation demonstrating efficacy and safety consistent with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for HIM/ICHRA, and CP.PMN.53 for Medicaid) or other evidence of coverage provisions.

Coding and Clinical Thresholds

Neutral product codesmixed

NDC	Not specified in this document

inv-08: Proteinuria / UPCR — ≥ 0.5 g/day OR UPCR ≥ 1.5 g/g

Proteinuria threshold for initiation≥ 0.5 g/day

Alternative threshold (UPCR)UPCR ≥ 1.5 g/g

Guideline basis for revisionRevised from 1 g/day to 0.5 g/day per 2025 KDIGO guidelines

inv-09: eGFR — ≥ 30 mL/min/1.73 m2

eGFR requirement for initiation≥ 30 mL/min/1.73 m2

DefinitioneGFR = estimated glomerular filtration rate

Role in criteria

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for Vanrafia (atrasentan) for IgAN; the provider must demonstrate that all initial approval criteria are met, including biopsy-confirmed diagnosis of IgAN, nephrology involvement, age ≥ 18 years, documentation of proteinuria and eGFR thresholds, RAAS inhibitor therapy and concomitant use unless contraindicated, and dosing limits (≤ 0.75 mg/day).

Diagnosis of IgAN confirmed via kidney biopsy
Prescribed by or in consultation with a nephrologist
Age ≥ 18 years
Proteinuria ≥ 0.5 g/day or UPCR ≥ 1.5 g/g and eGFR ≥ 30 mL/min/1.73 m2
Member on RAAS inhibitor at up to maximally tolerated doses for ≥ 12 weeks unless contraindicated; Vanrafia prescribed in combination with a RAAS inhibitor unless contraindicated
Dose does not exceed 0.75 mg/day

Prior Authorization

Initial approval duration — 12 months

Background on Atrasentan and Indication

Atrasentan (Vanrafia) is an endothelin receptor antagonist (ERA) granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A nephropathy who are at risk of rapid progression. The indication is based on reduction in proteinuria; an effect on slowing decline in kidney function has not been established. Current guideline‑based management includes optimized renin‑angiotensin‑aldosterone system (RAAS) blockade for patients with proteinuria exceeding 0.5 g/day.

Definitions and Abbreviations

inv-22: eGFR — Estimated glomerular filtration rate

TermEstimated glomerular filtration rate

AbbreviationeGFR

ContextUsed as a renal function threshold in initial approval criteria

inv-23: UPCR — Urine protein-to-creatinine ratio

TermUrine protein-to-creatinine ratio

AbbreviationUPCR

Use in policyAlternative measure for proteinuria (UPCR ≥ 1.5 g/g)

Policy Summary

PayerQualChoice

PolicyAtrasentan (Vanrafia) for IgA nephropathy

Policy CodePolicy CP.PHAR.727

Change TypeCriteria and duration revisions

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

Must be documented along with proteinuria to meet initial approval

inv-10: Proteinuria — >= 0.5 g/day (revised threshold)

Revised proteinuria threshold>= 0.5 g/day (per 2025 KDIGO guidance)

Previous thresholdPreviously 1 g/day prior to 2Q 2026 revision

Revision dateImplemented during 2Q 2026 annual review

inv-11: Initial approval duration — 12 months

Initial approval duration12 months

Change madeExtended from 6 to 12 months during 2Q 2026 annual review

Applies toInitial and continued therapy approvals for chronic maintenance use

Initial prior authorization approvals for Vanrafia have been extended to 12 months; prior authorization requirements remain subject to the Health Plan's processes.

Approval duration (initial and continued): 12 months

Step Therapy

RAAS inhibitor requirement before initiation

Member must be receiving a RAAS inhibitor at up to maximally tolerated doses for at least 12 weeks prior to initiation unless contraindicated, and Vanrafia must be prescribed in combination with a RAAS inhibitor unless contraindicated.

Examples of RAAS agents are listed in Appendix B (e.g., irbesartan, losartan, lisinopril, benazepril).
Document intolerance or contraindication if RAAS therapy not used.

Note

Apply professional judgment — policy is a guide

Providers are expected to exercise professional judgment when applying this policy; the document is a guide to medical necessity and does not prescribe specific step therapy sequences.

Policy guides coverage determinations but does not guarantee payment; follow clinical judgment and applicable plan procedures.

Documentation Required

Required documentation for authorization

Submit supporting documentation with the prior authorization request, such as office chart notes, laboratory results, or other clinical information, demonstrating the member meets all approval criteria.

Include biopsy report confirming IgAN, nephrology consult notes, proteinuria and eGFR results, RAAS treatment history and dosing, and current Vanrafia dosing.

Documentation Required

Medical necessity documentation — retain clinical justification

Document medical necessity consistent with generally accepted standards of medical practice and applicable coverage documents; the policy serves as a guide and does not guarantee payment.

Retain records that substantiate diagnosis, therapy response, and rationale for continued therapy per plan requirements.

Denial Risk

Non‑FDA indications may be denied without off‑label support

Requests for non–FDA approved (off‑label) indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies for the member's line of business.

Follow CP.CPA.09 for commercial, HIM.PA.154 for marketplace/ICHRA, and CP.PMN.53 for Medicaid when submitting off‑label requests.

Denial Risk

Coverage decisions subject to plan terms and limits

Coverage decisions and benefit administration are subject to the terms, conditions, exclusions, and limitations of the applicable coverage documents; deviations from those documents may result in denial.

Verify member-specific evidence of coverage, certificate of coverage, or contract terms prior to assuming coverage.

Denial Risk

Medicaid precedence — follow state Medicaid provisions

For Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy; conflicts with state rules may result in denials if the policy differs from state requirements.

Refer to the applicable state Medicaid manual for coverage provisions before processing requests.

inv-24: ERA — Endothelin receptor antagonist

TermEndothelin receptor antagonist

AbbreviationERA

RelevanceAtrasentan (Vanrafia) is an ERA used to reduce proteinuria in IgAN

inv-25: Health Plan — A health plan that has adopted this clinical policy and is operated or administered, in whole or in part, by Centene Management Company, ...

DefinitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

ScopeTerm used to clarify applicability of the clinical policy to plan administration and coverage decisions

ImplicationCoverage decisions remain subject to the health plan's terms, conditions, exclusions, and limitations