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ModifiedCignaPolicy IP0565

Nephrology - Filspari (sparsentan) coverage

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This policy governs prior authorization, medical necessity criteria, and coverage decisions for Filspari (sparsentan) for Cigna-administered health benefit plans, addressing FDA indications for FSGS and primary IgA nephropathy and who may prescribe and monitor therapy.

Policy Summary

PayerCigna

PolicyNephrology - Filspari (sparsentan) coverage

Policy CodePolicy IP0565

Change TypeMaterial coverage updates (added FSGSrevised IgAN proteinuria thresholdsprohibited combination therapy)

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionObtain prior authorization and document biopsy/genetic confirmation, UPCR or proteinuria, eGFR and prior ACEi/ARB optimization before initiating Filspari.

SourceLink

POLICY UPDATE CHANGES

Focal Segmental Glomerulosclerosis was added as a new condition of approval.

High-risk progression proteinuria threshold for Primary IgA Nephropathy was modified multiple times, most recently to urine protein-to-creatinine ratio ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day.

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

Documentation requirements were added for Primary IgA Nephropathy.

2FDA-indicated conditions

≥8Min age (FSGS)

≥18Min age (IgAN)

≥30eGFR threshold

UPCR ≥1.5 / ≥0.5Proteinuria thresholds

ProhibitedConcurrent use with other IgAN meds

Coverage and Medical Necessity Criteria

Focal Segmental Glomerulosclerosis (FDA-approved) - Initial Therapy

Approve for 1 year if the patient meets ALL of the following:

FSGS Initial Therapy Criteria: i. Patient is ≥ 8 years of age; AND ii. Patient has ONE of the following: (a) biopsy confirming the disease [documentation required] OR (b) genetic variant associated with the disease [documentation required]; AND iii. Patient does not have nephrotic syndrome (presence of nephrotic syndrome defined as current proteinuria > 3.5 g/day for adults or ≥ 2 g/g for patients <18 years and serum albumin <30 g/L with or without edema); AND iv. Patient has a urine protein-to-creatinine ratio ≥ 1.5 g/g [documentation required]; AND v. Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND vi. Patient has received the maximum or maximally tolerated dose of ONE of the following for ≥ 6 months prior to starting the medication: (a) an angiotensin converting enzyme inhibitor OR (b) an angiotensin receptor blocker; AND vii. The medication will not be used in combination with any renin-angiotensin-aldosterone system antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; AND viii. The medication is prescribed by or in consultation with a nephrologist.

Examples of genetic variants associated with FSGS (e.g., CD2AP, INF2, LMX1B, NPHS1, NPHS2, TRPC6, WT1, COL4A3-5, APOL1) and examples of prohibited co-medications are listed in policy.

Focal Segmental Glomerulosclerosis (FDA-approved) - Continuing Therapy

Approve (for patients currently receiving Filspari) if the patient meets ALL of the following:

FSGS Continuing Therapy Criteria: i. Patient is ≥ 8 years of age; AND ii. Patient has had a response to the requested medication (examples include reduction in urine protein-to-creatinine ratio from baseline); AND iii. Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND iv. The medication is not being used in combination with any renin-angiotensin-aldosterone system antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; AND v. The medication is prescribed by or in consultation with a nephrologist.

Example responses referenced in policy (e.g., reduction in UPCR from baseline).

Primary Immunoglobulin A Nephropathy (FDA-approved) - Initial Therapy

Approve for 1 year if the patient meets ALL of the following:

IgAN Initial Therapy Criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis has been confirmed by biopsy [documentation required]; AND iii. Patient is at high risk of disease progression, defined by BOTH: (a) patient meets ONE of the following: (1) proteinuria ≥ 0.5 g/day [documentation required] OR (2) urine protein-to-creatinine ratio ≥ 0.5 g/g [documentation required]; AND (b) patient has received the maximum or maximally tolerated dose of ONE of the following for ≥ 12 weeks prior to starting the medication: (1) an angiotensin converting enzyme inhibitor OR (2) an angiotensin receptor blocker; AND iv. According to the prescriber, patient has received ≥ 3 months of optimized supportive care (including blood pressure management, lifestyle modification, and cardiovascular risk modification); AND v. Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND vi. The medication will not be used in combination with any renin-angiotensin-aldosterone system antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; AND vii. The medication is prescribed by or in consultation with a nephrologist.

Policy references KDIGO intent to ideally maintain urine protein <0.5 g/day (ideally <0.3 g/day).

Primary Immunoglobulin A Nephropathy (FDA-approved) - Continuing Therapy

Approve for 1 year if the patient is currently receiving Filspari and meets the following:

IgAN Continuing Therapy Criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis has been confirmed by biopsy [documentation required]; AND iii. Patient has had a response to the requested medication (examples include reduction in urine protein-to-creatinine ratio or reduction in proteinuria from baseline); AND iv. Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND v. The medication is not being used in combination with any renin-angiotensin-aldosterone system antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; AND vi. The medication is prescribed by or in consultation with a nephrologist.

Example responses referenced in policy (e.g., reduction in UPCR from baseline).

Approved Indications and Key Thresholds

Policy covers Filspari for specified nephrology indications when criteria are met; includes changes over time to thresholds and added indications.

Conditions covered

Primary IgAN high-risk criteria (most recent): Patient is at high risk of disease progression defined by urine protein-to-creatinine ratio ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day.UPC ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day
Approval duration: 1 year per current policy.
FSGS requirements (as added): FSGS added as a condition of approval; patient must have received maximum or maximally tolerated ACE inhibitor or ARB for ≥ 6 months prior to initiation.ACEi/ARB ≥ 6 months
Addition of FSGS and threshold revisions are documented in the revision history with multiple effective dates.

Filspari (sparsentan) is considered not medically necessary when prescribed for any indication other than those explicitly listed in this policy. Requests for coverage that do not meet the approved indication-specific criteria (including but not limited to uses outside the documented FSGS and primary IgA nephropathy criteria) will be denied as not medically necessary.

Concurrent administration of Filspari with other medications specifically indicated for immunoglobulin A nephropathy (for example, Fabhalta and Vanrafia) is explicitly prohibited and will be considered not medically necessary.

Use of Filspari in combination with other agents for IgAN or for any purpose outside the criteria detailed in this policy is considered not medically necessary. Coverage is limited to the conditions and clinical thresholds specified in the approval criteria; combination therapy with other IgAN-directed medications is not covered.

Combination therapy with Filspari and other medications indicated for immunoglobulin A nephropathy is considered not medically necessary because there is a lack of controlled clinical trial evidence demonstrating additive efficacy for such combinations.

Key Clinical Thresholds and Definitions

eGFR — threshold for covered indications

eGFR threshold≥ 30 mL/min/1.73 m2

Source contextRequired for both FSGS and IgAN coverage criteria

DocumentationeGFR value must be provided in prior authorization request

FSGS UPCR threshold

FSGS UPCR thresholdUPCR ≥ 1.5 g/g

ContextRequired for FSGS initial therapy (documentation required)

Related requirementPatient must not have nephrotic syndrome to qualify

IgAN proteinuria/UPCR threshold

IgAN proteinuria/UPCR thresholdProteinuria ≥ 0.5 g/day OR UPCR ≥ 0.5 g/g

ContextDefines 'high risk of disease progression' for Primary IgA Nephropathy (documentation required)

Prior revisionsThresholds were revised over time as shown in revision history

Age (FSGS) minimum age

Minimum age for FSGS indication≥ 8 years

ContextApplies to both initial and continuing FSGS therapy

DocumentationAge must be documented in prior authorization request

Age (IgAN) minimum age

Minimum age for IgAN indication≥ 18 years

ContextApplies to both initial and continuing IgAN therapy

DocumentationAge must be documented in prior authorization request

Urine protein-to-creatinine ratio (latest high-risk threshold)

Latest high-risk UPCR thresholdUPCR ≥ 0.5 g/g

ContextUsed in most recent revision to define high risk of progression for IgAN

DocumentationUPCR must be provided (documentation required)

Proteinuria (latest high-risk threshold)

Latest high-risk proteinuria thresholdProteinuria ≥ 0.5 g/day

ContextAlternate criterion to UPCR for defining high risk of progression in IgAN

DocumentationProteinuria measurement must be provided (documentation required)

ACEi/ARB optimization duration for FSGS

ACEi/ARB optimization duration for FSGS≥ 6 months on maximum or maximally tolerated dose

ContextRequired prior to initiating Filspari for FSGS (documentation required)

ExamplesExamples of ACEi/ARB included in policy (e.g., lisinopril, losartan)

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required; approvals time‑limited and nephrology prescriber/monitor required

Prior authorization is required for benefit coverage of Filspari; all approvals are time‑limited and provided for the duration noted in the criteria (typically 1 year for initial and continuation approvals). Filspari must be prescribed by or in consultation with a physician who specializes in the condition being treated (nephrologist). Documentation may be requested where noted in the criteria.

Approvals are provided for the duration noted in the criteria; when authorized in months, 1 month = 30 days.
Prescriber/monitor: prescribed by or in consultation with a nephrologist.

Prior Authorization

Prior authorization criteria and approval durations updated in revision history

Prior authorization criteria and approval durations have been revised in multiple updates; proteinuria/UPCR thresholds for high‑risk Primary IgAN and the approval duration were changed over time, and FSGS was added as an approved condition.

Approval duration for initial and continuation therapy was changed to 1 year in revision history.
High‑risk proteinuria threshold for Primary IgAN was successively revised and most recently set to UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day.
Focal Segmental Glomerulosclerosis was added as a condition of approval in revision entries.

Step Therapy

Step therapy: maximum or maximally tolerated ACEi/ARB required before Filspari

Before initiating Filspari, the patient must have received the maximum or maximally tolerated dose of one ACE inhibitor or one ARB; the required duration differs by indication (see below).

FSGS: ACEi or ARB for ≥ 6 months prior to starting Filspari.
Primary IgAN: ACEi or ARB for ≥ 12 weeks prior to starting Filspari.

Step Therapy

ACEi/ARB optimization for FSGS: ≥ 6 months documented

For FSGS specifically, the policy requires documentation that the patient received the maximum or maximally tolerated dose of an ACE inhibitor or ARB for at least 6 months prior to initiation of Filspari; this must be recorded in the clinical record.

Documentation should show agent, dose, duration (≥ 6 months), and reason if treatment was limited by intolerance.

Documentation Required

Documentation required: biopsy/genetic testing, UPCR/proteinuria, prior therapy, eGFR, prescriber notes

Required documentation includes disease confirmation (biopsy or genetic testing where applicable), urine protein measurements (UPCR or proteinuria), prior treatment history including ACEi/ARB optimization, eGFR values, and prescriber specialty notes.

FSGS: biopsy confirming disease or genetic variant documentation when applicable.
IgAN: biopsy confirmation required for initial therapy.
UPCR/proteinuria values demonstrating thresholds (e.g., UPCR ≥ 1.5 g/g for FSGS; UPCR ≥ 0.5 g/g or proteinuria ≥ 0.5 g/day for IgAN).
Evidence of maximum or maximally tolerated ACEi/ARB therapy for the required duration.
Recent eGFR (≥ 30 mL/min/1.73 m2) and nephrology consultation/prescriber documentation.

Documentation Required

Documentation requirements for Primary IgAN added in revision history

Revision history records that documentation requirements for Primary Immunoglobulin A Nephropathy were added in May 2025; include any newly requested documentation elements per that update when submitting prior authorization.

Revision log entries: 05/15/2025 — Primary IgAN: Added documentation requirements; subsequent effective dates listed in revision history.

Denial Risk

Denial triggers: no prior authorization, non‑covered indications, prohibited combinations

Coverage will be denied if prior authorization is not obtained, if the requested use is outside the specified covered indications, or if the medication is requested in prohibited combinations (e.g., with RAAS antagonists, endothelin receptor antagonists, or aliskiren).

Failure to obtain prior authorization will result in coverage denial.
Non‑covered indications (any use outside specified criteria) will be denied.
Requests for combination use with RAAS antagonists, endothelin receptor antagonists, or aliskiren may be denied.

Denial Risk

Concurrent use with other IgAN medications triggers denial (not medically necessary)

Requests will be considered not medically necessary and may be denied when Filspari is administered concurrently with other medications indicated for IgA nephropathy (e.g., Fabhalta and Vanrafia); combination therapy is generally not recommended due to lack of controlled trial data supporting additive efficacy.

Concurrent use with other IgAN agents (examples: Fabhalta, Vanrafia) is listed as not medically necessary.
Policy states combination therapy is generally not recommended because of lack of controlled clinical trial data supporting additive efficacy.

Drug Background and Context

Filspari (sparsentan) is a dual endothelin and angiotensin II receptor antagonist. It is indicated under FDA-approved labeling and by this policy for specific nephrology indications when the patient meets the defined criteria; however, use outside those criteria—including concurrent use with other IgAN-directed therapies—is considered not medically necessary.

Clinical Definitions and Risk Categories

Nephrotic syndrome definition — proteinuria and serum albumin thresholds

Nephrotic syndrome proteinuria threshold (adults)Current proteinuria > 3.5 g/day

Nephrotic syndrome proteinuria threshold (patients <18 years)≥ 2 g/g

Serum albumin thresholdSerum albumin < 30 g/L (with or without edema)

High risk of progression — UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day (most recent revision)

High risk of progression (latest)UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day

ContextMost recent revision defines high risk for Primary IgA Nephropathy used in approval criteria

DocumentationMeeting either criterion must be documented in the prior authorization

Policy Change Log

2024-03-14threshold_revision

Primary IgA Nephropathy high-risk definition revised (effective 06/01/2024 entry referenced) and approval duration changed to 1 year for initial and continuation therapy (previously 9 months initial).

2024-10-24approval_duration_change

Approval duration for Primary IgA Nephropathy changed to 1 year for initial and continuation therapy; high-risk proteinuria criteria revised in this review.

2024-12-15review

Routine review with no criteria changes recorded on 12/15/2024.

2025-05-15documentation_update

Documentation requirements added for Primary Immunoglobulin A Nephropathy.

2025-07-31addition_of_denial_condition

Policy updated to add a condition not recommended for approval regarding concomitant use with other medications indicated for IgA nephropathy.

2026-02-19indication_added

Focal Segmental Glomerulosclerosis was added as a new condition of approval (entered in revision log).

2026-05-01indication_added_effective

Focal Segmental Glomerulosclerosis added as a new condition of approval (effective entry recorded 05/01/2026).

2026-06-18step_therapy_requirement

Focal Segmental Glomerulosclerosis requirement that patient has received maximum or maximally tolerated ACE inhibitor or ARB for ≥ 6 months was recorded in the revision log.

2026-08-01policy_effective_dateLatest

Policy effective date recorded and revisions through 08/01/2026 are in force, including the most recent modification to Primary IgA Nephropathy high-risk threshold (UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day) and inclusion of FSGS criteria; approvals are time-limited (typically 1 year).

2025-07-31policy_update

Added a condition not recommended for approval: concurrent use with other medications indicated for treatment of immunoglobulin A nephropathy.

2026-02-19material_change

Focal Segmental Glomerulosclerosis was added as a new condition of approval (revision log entry).

2026-05-01material_change_effective

Focal Segmental Glomerulosclerosis recorded as added and effective as a new condition of approval on 05/01/2026.

2026-06-18criteria_specification

Revision log documents the FSGS requirement that patients have received maximum or maximally tolerated ACE inhibitor or ARB for ≥ 6 months.

2026-08-01policy_effective_dateLatest

Policy effective date reflects incorporation of the FSGS addition and other material updates; this is the most recent effective policy snapshot.

Policy Summary

PayerCigna

PolicyNephrology - Filspari (sparsentan) coverage

Policy CodePolicy IP0565

Change TypeMaterial coverage updates (added FSGSrevised IgAN proteinuria thresholdsprohibited combination therapy)

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionObtain prior authorization and document biopsy/genetic confirmation, UPCR or proteinuria, eGFR and prior ACEi/ARB optimization before initiating Filspari.

SourceLink

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