CurrentmhnPolicy CP.PHAR.631

Sparsentan (Filspari)

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, contraindications, and administrative guidance for coverage of sparsentan (Filspari) across Commercial, ICHRA/HIM, and Medicaid lines of business for adults with primary IgA nephropathy.

Policy Summary

Payermhn

PolicySparsentan (Filspari)

Policy CodePolicy CP.PHAR.631

Change TypeAnnual review updates (2Q 2026) with criteria revision

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) to demonstrate the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Revised criterion for proteinuria ≥ 0.5 g/day per updated KDIGO 2025 guidance.

Added ICHRA line of business.

Added continuation requirement that Filspari is not prescribed concurrently with RAAS inhibitors, ERAs, or aliskiren.

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 2026-01-01.

Updated FDA Approved Indication to reflect conversion to full approval and expanded indication.

Added Filspari REMS information to Appendix D.

1Covered Indications (FDA-approved)

Adults (≥18)Age Group

>=0.5 g/day

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Proteinuria Threshold

400Max Dose (mg/day)

Coverage Summary

Policy coverage stance: covered_with_criteria; Sparsentan (Filspari) is indicated to slow kidney function decline in adults with primary IgA nephropathy at risk for progression. Scope: Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, contraindications, and administrative guidance for coverage across Commercial, ICHRA/HIM, and Medicaid lines of business. Effective date: 06.01.23; Last review date: 05.26. Filspari is dispensed only through a REMS program.

Key thresholds & quick facts

Proteinuria threshold>= 0.5 g/day

eGFR threshold>= 30 mL/min/1.73 m2

Age groupAdults (>=18)

Maximum daily dose400 mg/day

RAAS inhibitor trial>= 12 weeks at >= 50% of max labeled dose

Initial Therapy Criteria IgA Nephropathy

I. Initial Approval Criteria - Immunoglobulin A Nephropathy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of immunoglobulin A nephropathy (IgAN) confirmed via kidney biopsy
Prescribed by or in consultation with a nephrologist
Age >= 18 years
Documentation
- Proteinuria of >= 0.5 g/day>= 0.5 g/day

Initial Therapy — Other Diagnoses/Indications

I. Initial Approval Criteria - Other diagnoses/indications

If initial criteria do not apply or label changed recently (within 6 months):

ANY of the following

If drug has recently undergone a label change not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for line of business
See policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If requested use is not listed under section III and above does not apply, refer to off-label use policy for line of business
See policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

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Continuation Therapy Criteria — IgA Nephropathy

II. Continuation of Therapy - Immunoglobulin A Nephropathy

Covered when ALL of the following are met:

ALL of the following

Member eligibility continuing status (one of):
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to CC.PHARM.03A and CC.PHARM.03B)
Member response evidence (one of):
- Decrease in UPCR from baseline

Continuation Therapy — Other Diagnoses/Indications

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

Not covered when:

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required per policy criteria

Requests must meet the policy's initial or continuation criteria to be approved. Approval durations are: initial approvals — 6 months; continuation approvals — 12 months.

Documentation Required

Submit supporting documentation

Providers must submit supporting documentation such as office chart notes, laboratory results, and other clinical information to demonstrate that the member meets all approval criteria.

Documentation Required

Evidence of response for continuation

For continuation requests, providers must document treatment response with evidence such as a decrease in urine protein-to-creatinine ratio (UPCR) from baseline or a reduction in total urine protein per day from baseline.

Applicable Codes & Policy References

Clinical Evidence & Guideline References

Key evidence includes the PROTECT phase 3 trial (Rovin et al., Lancet 2023) demonstrating efficacy of sparsentan versus irbesartan; the Filspari Prescribing Information (Travere Therapeutics), August 2025 (accessed Jan 14, 2026); and the KDIGO 2025 guidance which updated the proteinuria threshold and recommends RAAS-first therapy for initial management.

Background & Drug Information

Sparsentan (Filspari) is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary IgA nephropathy who are at risk for progression. It is available as 200 mg and 400 mg tablets; recommended dosing begins at 200 mg once daily with increase to 400 mg once daily as maintenance (maximum 400 mg/day). Filspari is only available through the Filspari REMS and the policy aligns with KDIGO guidance; key clinical evidence includes the PROTECT trial and the Filspari prescribing information.

Drug facts

Available strengths200 mg, 400 mg tablets

REMS programYes (Filspari REMS)

FDA-approved indications1

Age groupAdults (>=18)

Definitions

IgAN: Immunoglobulin A nephropathy, a primary glomerular disease characterized by IgA deposition in the kidney.

eGFR: Estimated glomerular filtration rate, a measure of kidney function reported in mL/min/1.73 m2.

RAAS: Renin-angiotensin-aldosterone system, a hormonal system targeted by ACE inhibitors and ARBs to reduce proteinuria and slow CKD progression.

UPCR: Urine protein-to-creatinine ratio, a metric used to quantify proteinuria; ERA: Endothelin receptor antagonist, a class of drugs including agents that block endothelin receptors.

Revision History

03.26.26revisedLatest

Revised criterion for proteinuria ≥ 0.5 g/day per updated KDIGO 2025 guidance. (2Q 2026 annual review) - aligned proteinuria threshold with KDIGO 2025 guidance; references reviewed and updated.

03.26.26addedLatest

Added ICHRA line of business. (2Q 2026 annual review)

01.24.25

Policy Summary

Payermhn

PolicySparsentan (Filspari)

Policy CodePolicy CP.PHAR.631

Change TypeAnnual review updates (2Q 2026) with criteria revision

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) to demonstrate the member meets all approval criteria.

SourceLink

On This Page

Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m2>= 30 mL/min/1.73 m2

RAAS inhibitor step therapy

Failure of a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., irbesartan, losartan, lisinopril, benazepril) for at least 12 weeks
Unless contraindicated or clinically significant adverse effects are experienced
RAAS inhibitor therapy dose was at least 50% of maximum labeled dose
Unless contraindicated or clinically significant adverse effects are experienced
For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395
Applies only to Illinois HIM requests

Filspari is not prescribed concurrently with RAAS inhibitors, endothelin receptor antagonists (ERAs), or aliskiren

Dose limits

Dose does not exceed 400 mg per day<= 400 mg/day
Dose does not exceed 1 tablet per day<= 1 tablet/day

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I. Initial Approval Criteria - Other diagnoses/indications

Reduction of proteinuria as evidenced by a lower total urine protein per day from baseline

Filspari is not prescribed concurrently with RAAS inhibitors, endothelin receptor antagonists (ERAs), or aliskiren

Continuation-specific requirement

Dose increase limits (if request is for dose increase):

New dose does not exceed 400 mg per day<= 400 mg/day
New dose does not exceed 1 tablet per day<= 1 tablet/day

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II. Continuation of Therapy - Immunoglobulin A Nephropathy

Billing Rule

Dose limits

Dose limits: maximum sparsentan dose must not exceed 400 mg per day and must not exceed 1 tablet per day. Requests for dose increases must not exceed these limits.

Denial Risk

Concurrent therapy contraindication

Claims may be denied if Filspari is prescribed concurrently with renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), or aliskiren.

Step Therapy

RAAS inhibitor trial required prior to initiation

Prior to initiation, a trial of a RAAS inhibitor is required unless contraindicated: failure for at least 12 weeks while on a RAAS inhibitor at at least 50% of the maximum labeled dose. An Illinois HIM step therapy bypass applies per IL HB 5395 effective 2026-01-01.

IL HIM bypass per IL HB 5395 effective 2026-01-01

Documentation Required

REMS program requirement

Filspari is distributed via a restricted program (Filspari REMS). Providers and dispensing sites must comply with REMS program requirements when prescribing and dispensing Filspari.

Added continuation requirement that Filspari is not prescribed concurrently with RAAS inhibitors, endothelin receptor antagonists (ERAs), or aliskiren. (2Q 2025 annual review; carried forward)

07.14.25added

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 2026-01-01; referenced in criteria and Appendix D.

09.11.24revised

RT4 update: Updated FDA Approved Indication to reflect conversion to full approval and expanded indication. (09.11.24)

01.12.24added

Added Filspari REMS information to Appendix D. (2Q 2024 annual review)

Sparsentan (Filspari)

Coverage Summary

Initial Therapy Criteria  IgA Nephropathy

Initial Therapy — Other Diagnoses/Indications

Continuation Therapy Criteria — IgA Nephropathy

Continuation Therapy — Other Diagnoses/Indications

Diagnoses / Indications Not Authorized

Provider Actions & Authorization Requirements

Applicable Codes & Policy References

Clinical Evidence & Guideline References

Background & Drug Information

Definitions

Revision History

Initial Therapy Criteria IgA Nephropathy