CurrentCignaPolicy IP0565

Filspari (sparsentan) coverage for primary IgA nephropathy

Defines prior authorization, medical necessity criteria, and coverage conditions for Filspari (sparsentan) in adults with primary immunoglobulin A nephropathy (IgAN) for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyFilspari (sparsentan) coverage for primary IgA nephropathy

Policy CodePolicy IP0565

Change TypeAnnual review with material coverage revisions

Effective DateSep 1, 2025

Next Review DateJun 1, 2024

Key ActionObtain prior authorization and document biopsy, urine protein/UPCR, and prior ACEi/ARB optimization to support approval for 1 year.

SourceLink

POLICY UPDATE CHANGES

Added 'Patient is currently receiving Filspari' continuation criteria.

Lowered numeric thresholds defining high risk of disease progression from UPCR ≥ 1.5 g/g or proteinuria ≥ 1 g/day to UPCR ≥ 0.8 g/g or proteinuria ≥ 0.5 g/day.

Added documentation requirements to criteria.

Added a condition excluding concurrent use with other medications indicated for IgAN (e.g., Fabhalta and Vanrafia).

≥18Min age

≥30 mL/min/1.73 m2eGFR

≥0.5 g/day or UPCR ≥0.8 g/gProteinuria threshold

ACEi/ARB ≥12 wks

Policy Summary

PayerCigna

PolicyFilspari (sparsentan) coverage for primary IgA nephropathy

Policy CodePolicy IP0565

Change TypeAnnual review with material coverage revisions

Effective DateSep 1, 2025

Next Review DateJun 1, 2024

Key ActionObtain prior authorization and document biopsy, urine protein/UPCR, and prior ACEi/ARB optimization to support approval for 1 year.

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met for Initial Therapy (approve for 1 year):

Initial Therapy (A)

Age and diagnosis: i. Patient is ≥ 18 years of age; ii. The diagnosis has been confirmed by biopsy [documentation required]
High risk of progression: iii. Patient meets BOTH (a) and (b): (a) Patient meets ONE of the following: (1) Proteinuria ≥ 0.5 g/day [documentation required]; OR (2) Urine protein-to-creatinine ratio ≥ 0.8 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 Filspari: (1) Angiotensin converting enzyme inhibitor; OR (2) Angiotensin receptor blocker
Supportive care, renal function, and concomitant therapy: iv. According to the prescriber, patient has received ≥ 3 months of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification; v. Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; vi. The medication will not be used in combination with any renin-angiotensin-aldosterone antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; vii. The medication is prescribed by or in consultation with a nephrologist.

Continuation / Currently Receiving Filspari

Covered when ALL of the following are met for patients currently receiving Filspari (approve for 1 year):

Continuation Therapy (B)

Age and diagnosis: i. Patient is ≥ 18 years of age; ii. The diagnosis has been confirmed by biopsy [documentation required]
Response: iii. According to the prescriber, patient has had a response to Filspari (e.g., reduction in urine protein-to-creatinine ratio from baseline, reduction in proteinuria from baseline)
Renal function and concomitant therapy: iv. Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; v. The medication is not being used in combination with any renin-angiotensin-aldosterone antagonists (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; vi. The medication is prescribed by or in consultation with a nephrologist.

Not Medically Necessary / Conditions Not Covered

Not Medically Necessary: Filspari for any other use is considered not medically necessary, including concurrent use with other medications indicated for the treatment of IgAN (e.g., Fabhalta and Vanrafia).

Concurrent use of Filspari with other medications specifically indicated for the treatment of primary immunoglobulin A nephropathy (for example, Fabhalta and Vanrafia) is not covered. The policy states that the medication should not be administered in combination with other IgAN-directed agents because combination therapy is generally not recommended given the lack of controlled clinical trial data demonstrating additive benefit.

Any use of Filspari that does not meet the coverage criteria listed in this policy is considered not medically necessary. This includes uses outside the specified indications, dosing, or patient-selection criteria described in the policy and other scenarios not supported by the listed clinical criteria.

Coding and Clinical Thresholds

Covered/Required codes and billing notemixed

No codes listed

Proteinuria/UPCR thresholds — inv-07

Proteinuria thresholdProteinuria ≥ 0.5 g/day (documentation required)

UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g (documentation required)

Threshold applicationMeets component (a) of 'high risk of disease progression' for initial therapy criteria

eGFR threshold — inv-08

eGFR minimumEstimated glomerular filtration rate ≥ 30 mL/min/1.73 m2

ContextRequired for both initial therapy and continuation criteria

Documentation

Provider Requirements and Authorization Process

Prior Authorization

Prior authorization required — 1 year approvals; nephrologist prescribing

Prior authorization is required for benefit coverage of Filspari. All approvals are provided for the duration noted (approve for 1 year). Filspari must be prescribed by or in consultation with a physician who specializes in the condition being treated (nephrologist).

Approvals are provided for the duration noted (1 year for initial and continuation).
Medication must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Step Therapy

RAAS blockade prerequisite — ACEi/ARB ≥ 12 weeks

Before initiating Filspari, the patient must have received the maximum or maximally tolerated dose of an ACE inhibitor or an ARB for at least 12 weeks.

Key Definitions and Risk Criteria

High risk of disease progression — inv-14

High-risk definition (proteinuria/UPCR)Patient meets ONE of: proteinuria ≥ 0.5 g/day OR UPCR ≥ 0.8 g/g (documentation required)

RAAS blockade prerequisitePatient has received maximum or maximally tolerated dose of an ACE inhibitor or ARB for ≥ 12 weeks prior to starting Filspari

Combined requirementHigh risk requires BOTH the proteinuria/UPCR threshold AND prior maximal or maximally tolerated ACEi/ARB ≥ 12 weeks

Use in criteria setsThis high-risk definition is required for Initial Therapy approval (and informs continuation assessments)

Drug Background and Indication

Filspari (sparsentan) is a therapy for primary immunoglobulin A nephropathy. The policy’s Conditions Not Covered section reiterates that Filspari should not be used in combination with other medications indicated for IgAN and that combination therapy is generally not recommended in the absence of controlled trial evidence supporting additive efficacy.