CurrentCignaPolicy IP0740

Vanrafia (atrasentan) for primary IgA nephropathy

Defines prior authorization, coverage criteria, duration, and exclusions for Vanrafia (atrasentan) for treatment of adults with primary immunoglobulin A nephropathy (IgAN) under Cigna medical/drug benefit plans.

Policy Summary

PayerCigna

PolicyVanrafia (atrasentan) for primary IgA nephropathy

Policy CodePolicy IP0740

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior Authorization is required for Vanrafia; approve for 9 months when criteria are met.

POLICY UPDATE CHANGES

New policy created for Vanrafia with effective date 07/01/2025.

1Covered Indication (IgAN)

9mInitial approval duration

≥18Minimum age (years)

eGFR ≥30Renal function threshold

Coverage Summary

Scope: Defines prior authorization, coverage criteria, duration, and exclusions for Vanrafia (atrasentan) for treatment of adults with primary immunoglobulin A nephropathy (IgAN) under Cigna medical/drug benefit plans. Coverage stance: Covered with criteria. Status: CURRENT. Effective date: 07/01/2025; Last review: 07/01/2025. Headline thresholds: UPCR ≥ 1.5 g/g; Proteinuria ≥ 0.5 g/day; eGFR ≥ 30 mL/min/1.73 m2; ACEi/ARB pre-treatment ≥ 12 weeks; Optimized supportive care ≥ 3 months.

Initial Therapy Criteria

FDA-Approved Indication - Primary IgA Nephropathy

Approve for 9 months if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
The diagnosis has been confirmed by biopsy
Documentation Required
Patient is at high risk of disease progression (both a and b required)
- a) Proteinuria threshold (ONE of)
  - Proteinuria ≥ 0.5 g/day≥ 0.5 g/day
    Documentation Required
  - Urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g≥ 1.5 g/g
    Documentation Required
- b) Prior ACEi/ARB therapy (ONE of)
  - Patient has received or is currently receiving the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor (ACEi) for ≥ 12 weeks prior to starting Vanrafia≥ 12 weeks
  - Patient has received or is currently receiving the maximum or maximally tolerated dose of an angiotensin receptor blocker (ARB) for ≥ 12 weeks prior to starting Vanrafia≥ 12 weeks
According to the provider, patient has received ≥ 3 months of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification≥ 3 months
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2≥ 30 mL/min/1.73 m2
The medication is prescribed by or on consultation with a nephrologist

Continuation / Current Therapy Criteria

FDA-Approved Indication - Primary IgA Nephropathy

B) Patient is Currently Receiving Vanrafia

Patient is ≥ 18 years of age
The diagnosis has been confirmed by biopsy
Documentation Required
According to the prescriber, patient has had a response to Vanrafia
Examples: reduction in UPCR or reduction in proteinuria from baseline
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2≥ 30 mL/min/1.73 m2
The medication is prescribed by or on consultation with a nephrologist

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Vanrafia. When criteria are met, approvals are provided for a 9-month duration.

Policy identifier: IP0740

Documentation Required

Documentation requirements

Diagnosis must be confirmed by kidney biopsy. Proteinuria thresholds that must be documented include either 24-hour protein ≥ 0.5 g/day or urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. Acceptable documentation may include chart notes, laboratory tests, claims records, and other relevant information.

Documentation Required

Prescriber specialty requirement

Vanrafia must be prescribed by or on consultation with a nephrologist.

Denial Risk

Not medically necessary for other uses and combination therapy

Vanrafia is considered not medically necessary for any use other than the specified primary IgA nephropathy indication and is not covered for concurrent use with other medications indicated for IgAN (for example, Fabhalta and Filspari).

Documentation Required

Contraception and pregnancy risk monitoring

Vanrafia carries a Boxed Warning for embryofetal toxicity. Effective contraception must be started before initiating treatment and continued for 2 weeks after the last dose; providers should document counseling and contraception.

Clinical Evidence

36% relative reductionALIGN primary endpoint

38% vs -3%Geometric LS mean percent change in UPCR (Vanrafia vs placebo)

Evidence summary: The ALIGN trial (Phase III, n=270) enrolled adults with biopsy-proven IgAN, proteinuria ≥ 1.0 g/day at screening, eGFR ≥ 30 mL/min/1.73 m2, and required background maximum tolerated ACEi or ARB for ≥ 12 weeks. In the interim analysis at Week 36, Vanrafia showed a 36% relative reduction in UPCR vs placebo (geometric LS mean percent change 38% for Vanrafia vs -3% for placebo; P < 0.001). Approval basis: Accelerated approval based on reduction of proteinuria; clinical benefit on kidney function not established.

Background

Background: Vanrafia (atrasentan) is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk of rapid progression. It received accelerated approval based on reduction of proteinuria; whether it slows kidney function decline has not been established and continued approval may depend on confirmatory trials. The pivotal ALIGN trial enrolled adults with biopsy-proven IgAN, proteinuria ≥ 1.0 g/day at screening, eGFR ≥ 30 mL/min/1.73 m2, and required background therapy with the maximum tolerated dose of an ACEi or ARB for ≥ 12 weeks prior to entry.

Glossary: UPCR = Urine protein-to-creatinine ratio. eGFR = Estimated glomerular filtration rate.

Policy Summary

PayerCigna

PolicyVanrafia (atrasentan) for primary IgA nephropathy

Policy CodePolicy IP0740

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior Authorization is required for Vanrafia; approve for 9 months when criteria are met.

On This Page

OpenPayer

Vanrafia (atrasentan) for primary IgA nephropathy

Coverage Summary

Initial Therapy Criteria

Continuation / Current Therapy Criteria

Provider Actions & Administrative Requirements

Applicable Codes

Clinical Evidence

Background

Revision History