CurrentUnitedHealthcarePolicy N/A

Filspari (sparsentan) prior authorization for IgA nephropathy

Prior authorization and medical necessity criteria for coverage of Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy who are at risk for disease progression.

Policy Summary

PayerUnitedHealthcare

PolicyFilspari (sparsentan) prior authorization for IgA nephropathy

Policy CodePolicy N/A

Change TypeMaterial: added tried/failed agentsrevised disease progression criteria

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation including renal biopsy confirming primary IgA nephropathy, baseline eGFR (≥30), prior trial/failure of ACEi/ARB and other required therapies, and nephrology prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Added additional tried/failed agents as part of initial authorization requirements.

Updated disease progression criteria and clarified that use is to slow kidney decline.

Updated references including the Filspari package insert and KDIGO guideline.

12 monthsauthorization duration

eGFR ≥30minimum renal function

renal biopsydiagnosis confirmation

nephrologist

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Coverage Criteria for Filspari (sparsentan)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization for Filspari

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy.
Risk: Patient is at risk of disease progression.
Intended use: Used to slow kidney function decline and to reduce proteinuria.
Renal function threshold: Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m2.
Prior RAAS therapy and washout
- Prior RAAS trial: Patient is on a maximized stable dose of either a maximally tolerated ACE inhibitor OR a maximally tolerated ARB prior to initiating therapy (examples: captopril, enalapril; candesartan, valsartan).
- Discontinuation of interacting agents: Use of RAAS inhibitors (ACE inhibitors, ARBs), endothelin receptor antagonists (ERAs; e.g., Letairis, Opsumit, Tracleer), and Tekturna must be discontinued prior to initiating treatment.
Prior trials/contraindications (glucocorticoid): History of failure after a 30-day trial, contraindication, or intolerance to a glucocorticoid (e.g., methylprednisolone, prednisone).
Prior trials/contraindications (SGLT2 inhibitor): History of failure after a 30-day trial, contraindication, or intolerance to a SGLT2 inhibitor (e.g., Jardiance).
Prior trials/contraindications (Vanrafia): History of failure after a 30-day trial, contraindication, or intolerance to Vanrafia.
Prescriber: Prescribed by or in consultation with a nephrologist.

Reauthorization

Reauthorization covered when ALL of the following are met:

Reauthorization for Filspari: Documentation of positive clinical response demonstrated by a reduction in proteinuria.

Authorization will be issued for 12 months upon meeting reauthorization criteria.

Coverage is denied when required documentation or clinical criteria are not met. Specifically, lack of a documented renal biopsy confirming primary IgA nephropathy (IgAN), failure to show the patient is at risk for disease progression, or an eGFR below 30 mL/min/1.73 m2 will preclude approval. Additionally, absence of documentation of prior maximized or stable dosing of a renin‑angiotensin system agent (ACE inhibitor or ARB), or missing records of required trials/failures/contraindications/intolerance to a glucocorticoid, an SGLT2 inhibitor, or Vanrafia, and lack of a nephrologist prescriber or consult may lead to denial.

UnitedHealthcare may, at its discretion, approve initial authorization or reauthorization based solely on previous claims or medication history, diagnosis codes (ICD‑10), and/or automated claim logic despite the stated coverage criteria. Automated approval and re‑approval processes vary by program and therapeutic class; providers should be aware that supply limits or program‑specific rules may still apply.

Key Coding and Clinical Thresholds

eGFR threshold

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

Source criterion contextListed as a required condition in Initial Authorization criteria for Filspari

Effect on coverageApplicants with eGFR below 30 mL/min/1.73 m2 do not meet the policy’s eGFR eligibility requirement

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Filspari. Approvals are issued for 12 months.

Authorization duration: 12 months
State mandates and member-specific benefit plans may affect coverage

Step Therapy

Required Prior Therapies (Step Therapy)

Prior to initiation, the patient must have tried and failed, been intolerant of, or have a contraindication to a maximally tolerated ACE inhibitor or a maximally tolerated ARB. The patient must also have a history of failure (after a 30-day trial), contraindication, or intolerance to the following prior therapies: a glucocorticoid, an SGLT2 inhibitor, and Vanrafia.

Step therapy: trial of a maximally tolerated ACE inhibitor (e.g., captopril, enalapril) OR a maximally tolerated ARB (e.g., candesartan, valsartan)
Glucocorticoid (e.g., methylprednisolone, prednisone) — 30-day trial unless contraindicated/intolerant

Background — Indication and Drug Information

Sparsentan (Filspari) is indicated to slow kidney function decline and reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk for disease progression. Per the policy, eligibility requires an eGFR of ≥ 30 mL/min/1.73 m2, confirmation of IgAN by renal biopsy, prior trial and maximized/stable dosing of an ACE inhibitor or ARB, documented trials/failures/contraindications/intolerance to a glucocorticoid, an SGLT2 inhibitor, and Vanrafia, and that the medication be prescribed by or in consultation with a nephrologist.

Definitions and Terms

Primary IgA nephropathy (IgAN) — confirmation

Confirmation methodDiagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by renal biopsy

Where requiredSpecified as the first element of the Initial Authorization criteria for Filspari

Implication for documentationSubmit renal biopsy report showing findings consistent with primary IgAN

At risk for disease progression — policy requirement

Documentation requirementPatient must be documented as 'at risk of disease progression' to meet Initial Authorization

Quantitative thresholdsPolicy does not define additional quantitative risk thresholds beyond the eGFR cutoff (≥ 30 mL/min/1.73 m2)

Policy Revision History and Changes

2025-07criteria_updateLatest

Added additional required tried/failed agents to the initial authorization requirements.

2025-06references_update

Updated references cited in the policy.

2024-10criteria_update

Policy Summary

PayerUnitedHealthcare

PolicyFilspari (sparsentan) prior authorization for IgA nephropathy

Policy CodePolicy N/A

Change TypeMaterial: added tried/failed agentsrevised disease progression criteria

Effective DateOct 1, 2025

Next Review DateN/A

SourceLink

On This Page

SGLT2 inhibitor (e.g., Jardiance) — 30-day trial unless contraindicated/intolerant

Vanrafia — 30-day trial unless contraindicated/intolerant

Documentation Required

Required Documentation

Submit documentation confirming the diagnosis and clinical status to support medical necessity. Required documentation must include renal biopsy confirmation of primary IgA nephropathy, evidence the patient is at risk for disease progression, baseline labs, and documentation of prior therapy trials or reasons for not using those therapies.

Renal biopsy report confirming primary IgA nephropathy
Documentation that the patient is at risk of disease progression
Baseline labs including eGFR (must be ≥ 30 mL/min/1.73 m2) and proteinuria measurements
Documentation of maximized stable dose of ACE inhibitor or ARB prior to initiation, or rationale if not used
Records showing 30-day trials (or documented contraindication/intolerance) for glucocorticoid, SGLT2 inhibitor, and Vanrafia
Consultation or prescription by a nephrologist

Denial Risk

Denial Risks / Triggers for Denial

Applications may be denied if required elements are missing or criteria are not met. Common triggers for denial include absence of renal biopsy confirmation, lack of documented risk for progression, eGFR below policy threshold, failure to show required prior therapy trials or documented contraindications/intolerances, continued concurrent use of disallowed agents (RAAS inhibitors, ERAs, Tekturna), or lack of nephrology involvement.

No renal biopsy confirming primary IgA nephropathy
No documentation patient is at risk of disease progression
eGFR < 30 mL/min/1.73 m2
No proof of maximized ACE inhibitor or ARB trial or acceptable rationale
Missing 30-day trial documentation (or contraindication/intolerance) for glucocorticoid, SGLT2 inhibitor, or Vanrafia
Concurrent use of RAAS inhibitors, endothelin receptor antagonists, or Tekturna at initiation
Prescriber not a nephrologist or no nephrology consultation

Related requirementsRisk documentation is one of multiple required criteria including biopsy confirmation, prior therapies, and nephrology prescribing/consultation

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

2023-04policy_created

Program created and initial prior authorization/medical necessity criteria established for Filspari (sparsentan).