CurrentCignaPolicy IP0565

Filspari (sparsentan) for primary IgA nephropathy

This policy governs prior authorization and medical necessity criteria for coverage of Filspari (sparsentan tablets) for adults with primary immunoglobulin A nephropathy (IgAN) under Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyFilspari (sparsentan) for primary IgA nephropathy

Policy CodePolicy IP0565

Change TypeMaterial updates to criteria, thresholds, and approval duration

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of biopsy-confirmed IgAN, proteinuria/UPCR values, and evidence of prior RAAS inhibitor use.

SourceLink

POLICY UPDATE CHANGES

Added 'Patient is currently receiving Filspari' criteria.

High risk of disease progression threshold revised from urine protein-to-creatinine ratio ≥ 1.5 g/g or proteinuria ≥ 1 g/day to urine protein-to-creatinine ratio ≥ 0.8 g/g or proteinuria ≥ 0.5 g/day.

Approval duration for initial therapy changed to 1 year (previously 9 months).

Added documentation requirements for biopsy confirmation and proteinuria measurements.

Added a condition not recommended for approval: concurrent use with other medications indicated for IgAN (e.g., Fabhalta, Vanrafia).

≥18min age

≥30min eGFR

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≥0.5 g/day or ≥0.8 g/g

Coverage Criteria for Filspari (sparsentan)

Initial Therapy Criteria

Covered when ALL of the following are met (Initial Therapy):

Initial Therapy for Primary IgAN: Patient is ≥ 18 years of age; AND the diagnosis has been confirmed by biopsy; AND patient is at high risk of disease progression (meets BOTH proteinuria/UPCR and prior RAAS inhibitor requirements); AND patient has received ≥ 3 months of optimized supportive care (including blood pressure management, lifestyle modification, and cardiovascular risk modification); AND estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND the medication will not be used in combination with any renin-angiotensin-aldosterone antagonists, endothelin receptor antagonists, or aliskiren; AND the medication is prescribed by or in consultation with a nephrologist.see child nodes

Documentation required for biopsy and proteinuria/UPCR

High risk of disease progression (nested)

Both conditions required
- Proteinuria or UPCR
  - Proteinuria ≥ 0.5 g/day [documentation required]
  - Urine protein-to-creatinine ratio ≥ 0.8 g/g [documentation required]
- Prior RAAS inhibitor
  - Patient has received maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor for ≥ 12 weeks prior to starting Filspari
  - Patient has received maximum or maximally tolerated dose of an angiotensin receptor blocker for ≥ 12 weeks prior to starting Filspari

Supportive care: Patient has received ≥ 3 months of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification.

eGFR threshold: Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2.

Concomitant therapy exclusion: Medication will not be used in combination with any renin-angiotensin-aldosterone antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren.

Prescriber requirement: Medication is prescribed by or in consultation with a nephrologist.

Continuation Therapy Criteria

Covered when ALL of the following are met (Currently Receiving Filspari):

Continuation Therapy for Patients Currently Receiving Filspari: Patient is ≥ 18 years of age; AND the diagnosis has been confirmed by biopsy; AND according to the prescriber the patient has had a response to Filspari; AND estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND the medication is not being used in combination with any renin-angiotensin-aldosterone antagonists, endothelin receptor antagonists, or aliskiren; AND the medication is prescribed by or in consultation with a nephrologist.response examples include reduction in UPCR or proteinuria from baseline

Approve for 1 year

Response to therapy (examples)

Reduction in urine protein-to-creatinine ratio from baseline
Reduction in proteinuria from baseline

Concurrent use of Filspari with other medications indicated for the treatment of primary immunoglobulin A nephropathy (for example, Fabhalta or Vanrafia) is considered not medically necessary. The requested medication should not be administered in combination with other IgAN-specific therapies because combination therapy is generally not recommended due to a lack of controlled clinical trial data supporting additive efficacy.

Use of Filspari in combination with renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), or aliskiren is contraindicated per policy. RAAS inhibitors, ERAs, and/or aliskiren must be discontinued prior to initiation of Filspari, and Filspari must not be prescribed concurrently with these agents.

Filspari for any indication other than the specified primary IgA nephropathy criteria in this policy is considered not medically necessary. The policy excludes off-label or alternative uses outside the outlined coverage criteria.

Coding and Thresholds

Covered CPT Codesmixed

No codes listed

Proteinuria / UPCR thresholds

Proteinuria (24-hour)Proteinuria ≥ 0.5 g/day

Urine protein-to-creatinine ratio (UPCR)UPCR ≥ 0.8 g/g

DocumentationMeasurement of proteinuria or UPCR is required (documentation required).

eGFR threshold

eGFR thresholdeGFR ≥ 30 mL/min/1.73 m2

ApplicabilityRequired for both initial and continuation therapy approvals

DocumentationeGFR value must be reported in clinical documentation

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Filspari. All approvals are provided for the duration noted in the clinical criteria (typically 1 year). Approvals require that Filspari be prescribed by or in consultation with a specialist (nephrologist) due to the specialized evaluation, diagnosis, monitoring for adverse events, and long-term efficacy required.

Prior authorization required — Approve for 1 year for initial and continuation therapy when medical-necessity criteria are met.
Prescriber requirement — Must be prescribed by or in consultation with a nephrologist (specialist in the condition).
Approval duration — 1 year (1 month = 30 days when applicable).

Denial Risk

Denial Triggers / Claims Will Be Denied If Not Billed With Covered Codes

Claims submitted without covered diagnosis or procedure codes referenced in this policy, or services billed for conditions not covered under this policy, will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service.

Background

Filspari (sparsentan) is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid progression. Coverage under this policy applies when specified criteria are met, including age ≥ 18 years, biopsy-confirmed diagnosis, evidence of high risk of disease progression (for example, proteinuria ≥ 0.5 g/day or UPCR ≥ 0.8 g/g and prior treatment with a maximal or maximally tolerated ACE inhibitor or ARB for ≥ 12 weeks), and adequate renal function (eGFR ≥ 30 mL/min/1.73 m2). Safety considerations include a REMS program for hepatotoxicity and embryo-fetal toxicity.

Definitions and Risk Criteria

High risk of disease progression

Definition (policy)High risk of disease progression is defined as meeting BOTH: (1) proteinuria ≥ 0.5 g/day or UPCR ≥ 0.8 g/g, and (2) prior receipt of maximum or maximally tolerated ACEi or ARB for ≥ 12 weeks before starting Filspari.

ContextThis definition is used to determine eligibility for initial therapy under the coverage criteria.

DocumentationBiopsy confirmation and documentation of proteinuria/UPCR and prior RAAS inhibitor use are required where noted.

REMS

REMS programFilspari has a REMS to monitor hepatotoxicity and embryo-fetal toxicity

REMS objectivesMonitor liver enzyme elevations, ensure patients who can become pregnant are not pregnant before initiation, and minimize exposure during pregnancy

Policy Summary

PayerCigna

PolicyFilspari (sparsentan) for primary IgA nephropathy

Policy CodePolicy IP0565

Change TypeMaterial updates to criteria, thresholds, and approval duration

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of biopsy-confirmed IgAN, proteinuria/UPCR values, and evidence of prior RAAS inhibitor use.

SourceLink

On This Page

Concomitant therapy exclusion: Medication is not being used in combination with any renin-angiotensin-aldosterone antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren.

Prior RAAS inhibitor duration

Required durationMaximum or maximally tolerated ACE inhibitor or ARB for ≥ 12 weeks prior to starting Filspari

Agents referencedACE inhibitors or angiotensin receptor blockers (examples listed in policy)

Study precedentPROTECT trial required ≥ 12 weeks of ACEi/ARB prior to entry (patients discontinued ACEi/ARB 1 day before starting Filspari)

Denial triggers include: missing covered diagnosis/procedure codes, services not accompanied by covered codes under this Coverage Policy, or billing for conditions excluded by the member's benefit plan.
In the event of a conflict between this Coverage Policy and a customer's specific benefit plan document, the benefit plan document controls.

Documentation Required

Documentation is required where noted in the criteria. Documentation may include chart notes, laboratory tests, biopsy reports, claims records, and other supporting clinical information. Providers should submit the documentation at time of prior authorization request and retain records to support continued coverage.

Biopsy confirmation of IgA nephropathy is required [documentation required].
Evidence of proteinuria (protein ≥ 0.5 g/day or urine protein-to-creatinine ratio ≥ 0.8 g/g) is required [documentation required].
Documentation of response to therapy for patients currently receiving Filspari (e.g., reduction in UPCR or proteinuria from baseline) is required for continuation approvals.
Documentation of prior RAAS inhibitor use and dosing (see RAAS inhibitor prerequisite) is required.

Documentation Required

RAAS Inhibitor Prerequisite

Before initiating Filspari, the patient must have received the maximum or maximally tolerated dose of an ACE inhibitor or ARB for ≥ 12 weeks. This prerequisite must be documented in the medical record and submitted with the prior authorization request.

RAAS inhibitor prerequisite — Patient must have received an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) at the maximum or maximally tolerated dose for ≥ 12 weeks prior to starting Filspari.
Examples of ACE inhibitors: lisinopril, fosinopril, enalapril, benazepril (not exhaustive).
Examples of ARBs: irbesartan, losartan, candesartan, valsartan (not exhaustive).
If ACEi/ARB therapy was discontinued per study-like protocol or for intolerance, documentation of intolerance or reason for discontinuation is required.

Safety alertREMS accompanies the product and includes liver enzyme monitoring and pregnancy prevention measures