CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Filspari (sparsentan) — Coverage Criteria for IgA Nephropathy

Covers use of Filspari (sparsentan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid progression when specified authorization criteria are met; applies to Neighborhood Health Plan of Rhode Island Medicaid pharmacy benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilspari (sparsentan) — Coverage Criteria for IgA Nephropathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of kidney biopsy confirming IgAN, baseline proteinuria (24‑hr urine or UPCR) and eGFR to support a 6‑month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauth duration

≥30 to <90eGFR range

≥1 g/dayproteinuria threshold

1 tab/dayquantity limit

nephrologistprescriber

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilspari (sparsentan) — Coverage Criteria for IgA Nephropathy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of kidney biopsy confirming IgAN, baseline proteinuria (24‑hr urine or UPCR) and eGFR to support a 6‑month approval.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met

Indication: Medication is prescribed for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN)FDA-approved indication

Prescriber: Prescribed by or in consultation with a nephrologist

Diagnostic confirmation: Kidney biopsy confirming primary IgAN documented

Proteinuria: Baseline proteinuria >=1 g/day on 24-hour urine OR UPCR >=0.8 g/g on 24-hour urine

Renal function: eGFR >=30 and <90 mL/min/1.73 m2

RAS therapy status: Member has received a stable dose of maximally tolerated RAS inhibitor therapy (ACEI or ARB) for >=3 months prior OR member has intolerance/contraindication to RAS inhibitors

Concomitant therapy exclusion: Member is not using sparsentan in combination with an ACE inhibitor, ARB, endothelin receptor antagonist (ERA), aliskiren, Tarpeyo, or Fabhalta

Continuation Therapy

Covered for continued treatment when ALL of the following are met

Toxicity: No evidence of unacceptable toxicity or disease progression while on current regimen

Clinical benefit: Documentation of decreased proteinuria from baseline on 24-hour urine OR decrease in UPCR from baseline on 24-hour urine

Evidence of response required

Renal function: eGFR remains >=30 and <90 mL/min/1.73 m2

All indications other than the FDA-approved indication for primary immunoglobulin A nephropathy (IgAN) are considered experimental/investigational and not medically necessary.

Use of Filspari (sparsentan) for indications other than FDA-approved treatment of primary IgAN is not medically necessary.

Product and Clinical Thresholds

Covered drug (product)NDC | mixedCovered

Filspari

sparsentan tablets (200 mg and 400 mg) - product name and tablet strengths listed in policy

inv-06: eGFR range

eGFR range (initiation & continuation)eGFR ≥30 and <90 mL/min/1.73 m2

Source requirementDocumented eGFR must be reported in lab report/chart notes for authorization

Applies toBoth initial authorization and reauthorization (6-month approvals)

inv-07: Proteinuria threshold

Baseline proteinuria thresholdProteinuria ≥1 g/day on 24‑hour urine collection

Alternative UPCR thresholdUPCR ≥0.8 g/g on 24‑hour urine collection

DocumentationMust be shown in laboratory report and/or chart notes for initial authorization

Authorization, Documentation, and Denial Guidance

Prior Authorization

Prior Authorization and Quantity Limits

Prior authorization required. Approval may be granted for up to 6 months when all initiation or continuation criteria are met. Quantity limited to one tablet per day.

Prior authorization required for Filspari (up to 6 months when criteria met)
Quantity limit: 1 tablet/day (200 mg or 400 mg formulations)

Denial Risk

Indication Restriction

Filspari is indicated only for FDA‑approved use in primary immunoglobulin A nephropathy (IgAN). Use for indications other than FDA‑approved IgAN is considered experimental/investigational and not medically necessary and may be denied.

Denial Risk

Clinical Criteria Not Met / Denial Risk

Requests may be denied if required clinical criteria or documentation are not provided. Examples include failure to provide baseline kidney biopsy, 24‑hour urine protein/UPCR and eGFR documentation, not meeting proteinuria or eGFR thresholds, evidence of contraindicated combination therapy, or unacceptable toxicity/progression on therapy.

Denial risk if baseline kidney biopsy not provided
Denial risk if 24‑hour urine protein/UPCR does not meet threshold (≥1 g/day or UPCR ≥0.8 g/g)
Denial risk if eGFR not between ≥30 and <90 mL/min/1.73 m2
Denial risk if member is using contraindicated combinations (ACE inhibitor, ARB, endothelin receptor antagonist, aliskiren, Tarpeyo, or Fabhalta)

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request: kidney biopsy confirming primary IgAN; laboratory report and/or chart notes showing baseline proteinuria from a 24‑hour urine collection (≥1 g/day or UPCR ≥0.8 g/g); and documentation of eGFR (≥30 and <90 mL/min/1.73 m2). Additionally, documentation that the member has received a stable dose of maximally tolerated RAS inhibitor therapy (ACEI or ARB) for at least 3 months prior to initiation, or documentation of intolerance/contraindication to RAS inhibitors, is required. Prescribing or consulting nephrologist should be identified.

Kidney biopsy confirming primary IgAN
24‑hour urine protein report showing ≥1 g/day OR UPCR ≥0.8 g/g
eGFR documentation showing ≥30 and <90 mL/min/1.73 m2
Documentation of stable maximally tolerated RAS inhibitor (ACEI or ARB) for ≥3 months, or intolerance/contraindication to RAS inhibitors
Prescribing or consulting nephrologist identified in chart

OpenPayer

Filspari (sparsentan) — Coverage Criteria for IgA Nephropathy

Coverage Criteria for Filspari (sparsentan)

Product and Clinical Thresholds

Authorization, Documentation, and Denial Guidance

Background

Definitions and Measurement