CurrentBlue Cross Blue Shield - IowaPolicy 05.04.94

Filspari (sparsentan) — Coverage Criteria for IgA Nephropathy

Defines prior authorization, coverage criteria, dosing limits, and documentation requirements for Filspari (sparsentan) when used to reduce proteinuria and slow kidney function decline in adults with primary IgA nephropathy. Applies to Wellmark/Blue Cross Blue Shield members governed by the plan.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyFilspari (sparsentan) — Coverage Criteria for IgA Nephropathy

Policy CodePolicy 05.04.94

Change TypeMaterial updates (FDA approval, REMS noted, clarified criteria)

Effective DateAug 9, 2025

Next Review DateJan 1, 2025

Key ActionSubmit prior authorization with kidney biopsy confirmation, UPCR >= 0.8 g/g or proteinuria >=1 g/day, and documentation of stable RAS inhibitor therapy for ≥3 months.

SourceLink

POLICY UPDATE CHANGES

Filspari received full FDA approval in September 2024 and coverage criteria reference the approved indication to slow kidney function decline in adults with primary IgA nephropathy.

REMS requirement for hepatotoxicity and embryofetal toxicity is noted as an FDA requirement for Filspari.

Initial and continuation authorization durations and specific numeric thresholds for proteinuria, UPCR, age, and eGFR are specified.

>= 1 g/dayproteinuria threshold

>= 30eGFR minimum

9 monthsinitial auth

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Coverage Criteria for Filspari (sparsentan)

Initial Therapy Criteria

Authorization of up to 9 months may be granted when ALL of the following are met:

Initial Approval

Age: Member is 18 years of age or older>=18 years
Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy
Proteinuria / UPCR and RAS inhibitor: Proteinuria >= 1 g/day OR UPCR >= 0.8 g/g despite receiving a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor therapy (ACEI or ARB) for at least 3 monthsproteinuria >=1 g/day OR UPCR >=0.8 g/g; RAS therapy >=3 months
RAS inhibitors include ACEIs or ARBs
eGFR: Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m2>=30 mL/min/1.73 m2
Concomitant therapy exclusions: Requested medication will not be used in combination with Tarpeyo (budesonide), Fabhalta (iptacopan), or Vanrafia (atrasentan)
Avoid other endothelin receptor antagonists and aliskiren per policy exclusions

Continuation Therapy Criteria

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Continuation Approval

Ongoing use indication: Using the medication for proteinuria reduction in primary IgAN
Evidence of positive clinical response (one required): Member achieves or maintains a positive clinical response as evidenced by at least one of the following: maintenance of eGFR >= 30 mL/min/1.73 m2; reduction in proteinuria from baseline; or reduction in UPCR from baselineeGFR >=30 mL/min/1.73 m2 OR reduction in proteinuria or UPCR from baseline
Continuation requests should include chart notes or medical record documentation supporting the response

Do not administer Filspari in combination with Tarpeyo (budesonide), Fabhalta (iptacopan), Vanrafia (atrasentan) or other endothelin receptor antagonists (ERAs), or aliskiren. Avoid concomitant use with strong CYP3A4 inducers or inhibitors. The policy also notes the FDA-required REMS for hepatotoxicity and embryofetal toxicity and lists additional safety concerns (hypotension, acute kidney injury, hyperkalemia, fluid retention) that inform these coadministration exclusions.

Filspari is considered not medically necessary for members who do not meet the specified initial or continuation criteria. Denial conditions include failure to meet the age requirement (≥ 18 years), absence of kidney biopsy confirming primary IgA nephropathy, proteinuria below the policy threshold (proteinuria < 1 g/day or UPCR < 0.8 g/g), lack of documentation of prior stable maximally tolerated RAS inhibitor therapy for at least 3 months, or eGFR < 30 mL/min/1.73 m2. Members who do not demonstrate a positive clinical response for continuation (no maintenance of eGFR ≥ 30 mL/min/1.73 m2 or no reduction in proteinuria/UPCR from baseline) are also considered not medically necessary.

Billing and Coding

Billing codes (general instruction)mixed

Not specified

Policy references use of appropriate CPT, HCPCS, Revenue, and ICD diagnostic codes but does not list specific codes.

Proteinuria / UPCR thresholds

Proteinuria threshold (daily)Proteinuria >= 1 g/day

UPCR alternative thresholdUPCR >= 0.8 g/g

Context for thresholdThreshold applies despite stable, maximally tolerated RAS inhibitor therapy for at least 3 months

eGFR requirements

Minimum eGFR for initiation>= 30 mL/min/1.73 m2

Minimum eGFR for continuation>= 30 mL/min/1.73 m2 (may be used to demonstrate ongoing clinical response)

Role in continuation criteria

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy with Filspari (sparsentan). Authorization of up to 9 months may be granted for initial approval when all clinical criteria are met. Submit a complete prior authorization request with the required documentation described below to initiate review.

Initial authorization duration: up to 9 months
Continuation authorization duration: up to 12 months

Documentation Required

RAS inhibitor requirement prior to Filspari

Members must have been on a stable, maximally tolerated renin-angiotensin system (RAS) inhibitor (ACE inhibitor or ARB) for at least 3 months prior to initiation of Filspari. Document the specific RAS agent, dose, start date, and evidence of stability or maximal tolerated dose in the medical record/chart notes.

Acceptable RAS agents: ACEIs or ARBs
Document length of therapy: ≥ 3 months

Background on Filspari (sparsentan)

Filspari (sparsentan) is an oral, once-daily dual endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria and slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN). Efficacy was demonstrated in randomized trials (PROTECT) showing meaningful reductions in proteinuria/UPCR and improvement in eGFR trajectory compared with irbesartan. Safety concerns include potential hepatotoxicity and embryofetal risk, for which the FDA requires a REMS, as well as risks of hypotension, acute kidney injury, hyperkalemia, and fluid retention; because of its mechanism and interactions, Filspari should not be coadministered with RAS inhibitors, ERAs, or aliskiren.

Key Definitions

IgA nephropathy (IgAN)

DefinitionPrimary immunoglobulin A nephropathy (IgAN) is the diagnosis for which Filspari is indicated to slow kidney function decline in adults at risk of rapid progression

Diagnostic confirmation requiredDiagnosis must be confirmed by kidney biopsy for initial authorization

Therapeutic goalTreatment with Filspari is intended to reduce proteinuria and slow decline in kidney function in IgAN

Urine protein-to-creatinine ratio (UPCR) threshold

UPCR numeric cutoffUPCR >= 0.8 g/g

Clinical implicationUPCR >= 0.8 g/g identifies members at risk for disease progression and is used as an alternative to urinary protein >= 1 g/day for authorization

Revision History

2024-09FDA approval

Filspari (sparsentan) received full FDA approval in September 2024 for slowing kidney function decline in adults with primary IgA nephropathy, based on PROTECT trial results.

2024-09Safety/REMS noted

FDA requires a REMS for Filspari addressing hepatotoxicity and embryofetal toxicity; prescribers should be aware of REMS obligations.

2025-08-09Policy effective dateLatest