ModifiedColorado Rocky Mountain Health PlansPolicy N/A

Filspari™ (sparsentan) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines initial authorization and reauthorization clinical criteria, prescriber requirement, duration, and ancillary program rules for Filspari (sparsentan) for treatment of primary IgA nephropathy (IgAN) in adults under UnitedHealthcare commercial plans; effective date listed in header.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyFilspari™ (sparsentan) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy N/A

Change TypeUpdated clinical criteria and references (most recently 3/2026)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit documentation of renal biopsy confirming primary IgAN, evidence patient is at risk of progression, eGFR (≥30 mL/min/1.73 m2), history of maximized ACE inhibitor or ARB use, discontinuation of RAAS/ERA/Tekturna prior to initiating, glucocorticoid failure/contraindication/intolerance, and that prescriber is a nephrologist or consulted nephrologist.

SourceLink

POLICY UPDATE CHANGES

New program created 4/2023.

Updated disease progression criteria and statement that use is to slow kidney decline (10/2024).

Updated references (6/2025 and 7/2025).

Added additional tried/failed agents (7/2025).

Added budesonide as a corticosteroid example and removed step through SGLT2 and Vanrafia; updated references (3/2026).

12 monthsAuthorization Duration

≥30Minimum eGFR for initiation

BiopsyDiagnostic requirement

NephrologistPrescriber requirement

Coverage Summary

Coverage stance: covered_with_criteria for Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. Effective date: 2026-06-01. Payer/scope: UnitedHealthcare commercial prior authorization/medical necessity program. Authorization duration: 12 months. Policy and criteria reference the Filspari package insert (August 2025) and KDIGO 2025 guidance.

Key thresholds and quick facts

Minimum eGFR for initiationeGFR ≥ 30 mL/min/1.73 m2

Diagnostic requirementRenal biopsy confirming primary IgA nephropathy (IgAN) required

Prescriber requirementPrescribed by or in consultation with a nephrologist

Authorization duration12 months

Initial Therapy Criteria

Initial Authorization

Filspari will be approved based on all of the following:

ALL of the following

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

Continuation / Reauthorization Criteria

Reauthorization

Filspari will be approved for reauthorization when the following is documented:

Documentation of positive clinical response demonstrated by a reduction in proteinuria

Exclusions / Important Limitations

Exclusions/requirements: Patients must discontinue RAAS inhibitors, endothelin receptor antagonists (ERAs), and Tekturna (aliskiren) prior to initiating Filspari. Patients with eGFR < 30 mL/min/1.73 m2 are not eligible for initiation (policy requires eGFR ≥ 30 mL/min/1.73 m2). Policy applies to adults with primary IgAN with diagnosis confirmed by renal biopsy; prescriber must be a nephrologist or in consultation with one. A history of glucocorticoid failure/contraindication/intolerance is required (30-day trial for glucocorticoid failure).

Applicable Codes

Drugs referenced in criteria examplesmixed

ACE inhibitors	e.g., captopril, enalapril (maximally tolerated dose prior to initiating Filspari)
ARBs	e.g., candesartan, valsartan (maximally tolerated dose prior to initiating Filspari)
ERAs	Examples: Letairis, Opsumit, Tracleer
Tekturna	aliskiren - must be discontinued prior to initiating Filspari
Glucocorticoids	e.g., budesonide, methylprednisolone, prednisone (history of failure/contraindication/intolerance required)

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required with specific documentation

Submit prior authorization with documentation including: renal biopsy confirming primary IgAN; evidence the patient is at risk for disease progression and is being treated to slow kidney function decline and reduce proteinuria; current eGFR value (≥ 30 mL/min/1.73 m2); history of maximized, stable ACE inhibitor or ARB use prior to initiating Filspari; confirmation that RAAS inhibitors, ERAs, and Tekturna were discontinued prior to initiation; history of glucocorticoid failure after a 30-day trial or documented contraindication/intolerance (examples: budesonide, methylprednisolone, prednisone); and that the prescriber is a nephrologist or that nephrology consultation occurred.

Renal biopsy confirming primary IgAN
Evidence patient is at risk of progression and intent to slow kidney decline/reduce proteinuria
eGFR value (≥ 30 mL/min/1.73 m2)
History of maximized, stable ACE inhibitor or ARB use
Discontinuation of RAAS inhibitors, ERAs, and Tekturna prior to initiating
History of glucocorticoid failure after a 30-day trial or contraindication/intolerance (e.g., budesonide)
Prescriber is a nephrologist or documentation of nephrology consultation

Clinical Evidence & References

Evidence and approvals: P&T approval dates include 4/2023, 10/2024, 6/2025, 7/2025, 3/2026. The policy references the Filspari package insert: Filspari [package insert], Traverse Therapeutics, Inc; August 2025, and the KDIGO 2025 guideline for IgAN/IgAV. The policy explicitly references these sources to align criteria with the indication and guidance.

Background & Definitions

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. The policy aligns medical necessity criteria with the product labeling and KDIGO 2025 guidance and references the Filspari package insert (August 2025).

Definitions: Primary immunoglobulin A nephropathy (IgAN): diagnosis must be confirmed by renal biopsy per policy. Maximally tolerated dose: the highest dose of an ACE inhibitor or ARB tolerated by the patient prior to initiating Filspari.

Revision History

4/2023program_created

New program created.

10/2024policy_updated

Updated disease progression criteria and clarified that use is to slow kidney function decline; updated references.

6/2025references_updated

Updated references.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyFilspari™ (sparsentan) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy N/A

Change TypeUpdated clinical criteria and references (most recently 3/2026)

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Prior RAAS/ERA/Tekturna requirements

Patient is on a maximized stable dose with one of the following prior to initiating therapy: - maximally tolerated angiotensin converting enzyme (ACE) inhibitor (e.g., captopril, enalapril) - maximally tolerated angiotensin II receptor blocker (ARB) (e.g., candesartan, valsartan)
Use of renin-angiotensin-aldosterone system (RAAS) inhibitors (e.g., ACE inhibitors, ARBs), endothelin receptor antagonists (ERAs) (e.g., Letairis, Opsumit, Tracleer), and Tekturna will be discontinued prior to initiating treatment

History of failure (after a 30-day trial), contraindication or intolerance to a glucocorticoid (e.g., budesonide, methylprednisolone, prednisone)30 days (failure after a 30-day trial)

Prescribed by or in consultation with a nephrologist

Documentation Required

Reauthorization documentation

For reauthorization, provide documentation of a positive clinical response demonstrated by a reduction in proteinuria.

Billing Rule

Authorization duration

Authorizations are issued for a duration of 12 months.

Denial Risk

Automated approvals possible

UnitedHealthcare may approve initial or reauthorization requests automatically based on prior claims/medication history, diagnosis codes (ICD-10), and/or claim logic; however, absence of the required documentation may lead to denial if the request is later subjected to manual review.

7/2025references_and_criteria_updated

Updated references and added additional tried/failed agents (expanded therapeutic trial requirements).

3/2026policy_revisedLatest

Added budesonide as a corticosteroid example and removed previous step therapy through SGLT2 and Vanrafia; updated references.