Subject: Filspari SGM 5791-A P2025a

Drug

FILSPARI  (sparsentan)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications¹

Filspari is indicated:

·        To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

·        To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Primary Immunoglobulin A Nephropathy (IgAN)

·        Initial requests:

§  Kidney biopsy confirming a diagnosis of primary immunoglobulin A nephropathy (IgAN).

§  Laboratory report and/or chart note(s) of baseline proteinuria or baseline urine protein-to-creatinine ratio (UPCR) obtained within 3 months prior to initiation of the requested drug.^C,D

·        Continuation requests: Laboratory report and/or chart note(s) indicating the member has experienced benefit from therapy (e.g., decreased levels of proteinuria from baseline, decrease in UPCR from baseline, stabilization of proteinuria, UPCR, or kidney function).^D

Focal Segmental Glomerulosclerosis (FSGS)

·        Initial requests:

§  Kidney biopsy confirming a diagnosis of FSGS or chart notes or medical record documentation confirming diagnosis of FSGS genetic mutation in a podocyte protein associated with FSGS.

§  Laboratory report and/or chart note(s) of baseline UPCR obtained within 3 months prior to initiation of the requested drug.

§  Chart notes or medical record documentation confirming that member does not have nephrotic syndrome.

·        Continuation requests: Laboratory report and/or chart note(s) indicating the member has experienced benefit from therapy (e.g., decrease in UPCR).

Prescriber Specialties

This medication must be prescribed by or in consultation with a nephrologist.

Coverage Criteria

Primary Immunoglobulin A Nephropathy (IgAN)^1-4,A-D

Authorization of 12 months may be granted when all of the following criteria are met:

·        Member has a diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy.

·        Member has either of the following obtained within 3 months prior to initiation of the requested drug:

§  Proteinuria greater than or equal to 0.5 g/day

§  UPCR greater than or equal to 0.5 g/g

·        Member has received a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor therapy (e.g., angiotensin converting enzyme inhibitor [ACEI] or angiotensin II receptor blocker [ARB]) for at least 3 months prior to initiation of therapy, or member has an intolerance or contraindication to RAS inhibitors.

Focal Segmental Glomerulosclerosis (FSGS)¹

Authorization of 12 months may be granted for members 8 years of age or older when all of the following criteria are met:

·        Member has a diagnosis of focal segmental glomerulosclerosis (FSGS) confirmed by either of the following:

§  Kidney biopsy

§  Documentation of a genetic mutation in a podocyte protein associated with FSGS

·        Member has a UPCR greater than or equal to 0.3 g/g obtained within 3 months prior to initiation of the requested drug.

·        Member does not have nephrotic syndrome defined by either of the following:

§  For members 18 years of age or older, member meets either of the following:

§  Proteinuria less than or equal to 3.5 g/day or UPCR less than or equal to 3.5 g/g

§  Proteinuria greater than 3.5 g/day or UPCR greater than 3.5 g/g AND serum albumin greater than or equal to 3 g/dL

§  For members less than 18 years of age or older, member meets either of the following:

§  Proteinuria less than 1000 mg/m²/day or UPCR less than 2 g/g

§  Proteinuria greater than or equal to 1000 mg/m²/day or UPCR greater than or equal to 2 g/g AND serum albumin greater than or equal to 3 g/dL

Other

Member will not use the requested medication concomitantly with ARB, endothelin receptor antagonists [ERA], or renin-angiotensin-aldosterone system (RAAS) inhibitors (i.e., aliskiren).

Continuation of Therapy

Primary Immunoglobulin A Nephropathy (IgAN)^D

Authorization of 12 months may be granted for continued treatment in all members (including new members) who are currently receiving the requested medication and who are experiencing benefit from therapy (e.g., decreased levels of proteinuria from baseline, decrease in UPCR from baseline, stabilization of proteinuria, UPCR, or kidney function).

Focal Segmental Glomerulosclerosis (FSGS)

Authorization of 12 months may be granted for continued treatment in all members (including new members) who are currently receiving the requested medication and who are experiencing benefit from therapy (e.g., decrease in UPCR from baseline).

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Filspari [package insert]. San Diego: Travere Therapeutics, Inc.; April 2026.

2.     ClinicalTrial.gov. National Library of Medicine (US). Identifier NCT03762850 A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT). September 6, 2023. Available from: https://clinicaltrials.gov/ct2/show/study/NCT03762850.

3.     Fellstrom BC, Baratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomized, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389 (10084): 2117-2127.

4.     Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025 Oct; 108 (4S): S1-S71.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 16, 2026