ModifiedUnitedHealthcarePolicy N/A

Filspari™ (sparsentan), Vanrafia™ (atrasentan) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

UnitedHealthcare prior authorization/notification policy for the pharmacy coverage of Filspari (sparsentan) and Vanrafia (atrasentan) for adults with primary immunoglobulin A nephropathy (IgAN). Defines initial authorization and reauthorization clinical criteria, approval durations, and note about state mandates, automated approvals, and other utilization management rules.

Policy Summary

PayerUnitedHealthcare

PolicyFilspari™ (sparsentan), Vanrafia™ (atrasentan) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy N/A

Change TypeNew prior authorization/notification program; Vanrafia noted as accelerated approval

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization/notification with documentation of primary IgAN, risk of progression, and intended treatment goal; approvals are issued for 12 months and reauthorization requires documentation of positive clinical response.

SourceLink

POLICY UPDATE CHANGES

New prior authorization/notification program for Filspari and Vanrafia was created with P&T approval 6/2025 and effective date 9/1/2025.

Vanrafia noted as accelerated approval based on reduction of proteinuria; continued approval may be contingent on confirmatory trial.

12 moInitial authorization duration

12 moReauthorization duration

≥1.5 g/gVanrafia UPCR context

Coverage Summary & Scope

UnitedHealthcare prior authorization/notification policy for pharmacy coverage of Filspari (sparsentan) and Vanrafia (atrasentan) for adults with primary immunoglobulin A nephropathy (IgAN). Defines initial authorization and reauthorization clinical criteria and approval durations. Initial approvals for Filspari and Vanrafia are issued for 12 months, and reauthorization approvals are also issued for 12 months. The policy notes that state mandates, federal regulatory requirements, member benefit plans, other utilization management programs, and medical necessity or supply limits may affect coverage. UnitedHealthcare may also use automated approval processes based on previous claims/medication history, diagnosis codes (ICD-10) and/or claim logic which vary by program or therapeutic class.

Coverage stance: covered_with_criteria. Effective date: 2025-09-01. Last review: 2025-06-01.

Initial Therapy Criteria

Initial Authorization - Filspari

Covered when ALL of the following are met:

Diagnosis of primary immunoglobulin A nephropathy (IgAN)
Risk: Patient is at risk of disease progression
Indication: Used to slow kidney function decline
Filspari indicated to slow kidney function decline in adults with primary IgAN at risk for progression (see package insert).

Initial Authorization - Vanrafia

Covered when ALL of the following are met:

Diagnosis of primary immunoglobulin A nephropathy (IgAN)
Risk: Patient is at risk of disease progressionGenerally UPCR ≥ 1.5 g/g for rapid progression
Indication: Used to reduce proteinuria
Vanrafia approved under accelerated approval based on reduction of proteinuria; effect on kidney function decline not established.

Reauthorization / Continuation Criteria

Reauthorization

Covered when the following is met:

Clinical response: Documentation of positive clinical response

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization/notification is required and approvals will be issued for 12 months for initial authorizations of Filspari and Vanrafia; reauthorization approvals are also issued for 12 months contingent upon documentation of positive clinical response.

Initial approval duration: 12 months
Reauthorization duration: 12 months (contingent on documentation of positive clinical response)

Documentation Required

Clinical documentation for eligibility

Provider must document diagnosis of primary IgAN, that the patient is at risk of disease progression, and for Filspari that it is being used to slow kidney function decline or for Vanrafia to reduce proteinuria; for reauthorization, documentation of positive clinical response is required.

Applicable Codes

Relevant diagnosis codes mentioned (ICD-10)ICD-10

No codes listed

Clinical Evidence & Background

Evidence cited includes: Package inserts: Filspari and Vanrafia package inserts (April 2025); and Guideline: KDIGO 2021 Glomerular Diseases Guideline.

Note: Vanrafia received accelerated approval based on reduction of proteinuria; its effect on slowing kidney function decline has not been established and continued approval may depend on confirmatory trials.

Background

Filspari (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. Vanrafia (atrasentan) is indicated to reduce proteinuria in adults with primary IgAN at risk of rapid progression (generally UPCR ≥ 1.5 g/g). Vanrafia is approved under accelerated approval based on reduction of proteinuria; it has not been established whether Vanrafia slows kidney function decline in patients with IgAN, and continued approval may be contingent on verification of clinical benefit in a confirmatory trial.

Revision History

6/2025P&T approval

New prior authorization/notification program (Program number 2025 P 1479-1) for Filspari (sparsentan) and Vanrafia (atrasentan) received P&T approval.

9/1/2025effective dateLatest

Prior authorization/notification program (2025 P 1479-1) for Filspari and Vanrafia became effective; initial and reauthorization approvals issued for 12 months with criteria for diagnosis, risk of progression, and treatment intent.

April 2025regulatory/label note