CurrentAvMedPolicy N/A

Filspari (sparsentan) prior authorization

Requirements and documentation needed for pharmacy prior authorization or step-edit requests for Filspari (sparsentan) for AvMed members; applies to prescribers and specialty pharmacy processing these requests.

Policy Summary

PayerAvMed

PolicyFilspari (sparsentan) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and submit required clinical documentation, including recent labs, to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsReauthorization duration

1/dayQuantity limit

≥18Minimum age

eGFR ≥30eGFR requirement

Coverage Criteria — Filspari (sparsentan)

Policy Summary

PayerAvMed

PolicyFilspari (sparsentan) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and submit required clinical documentation, including recent labs, to support approval.

SourceLink

On This Page

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Demographics and provider: Member is 18 years of age or older AND provider is a nephrologist

Initial Authorization: 6 months

Diagnosis: Biopsy-proven, primary immunoglobulin A nephropathy (IgAN) and at risk of rapid disease progression

clinical diagnosis requirement

Renal status: Member is NOT currently receiving dialysis and has NOT undergone a kidney transplant

Background RAAS therapy: Member is established on a stable and maximally tolerated dose of a RAAS inhibitor (ACE inhibitor or ARB) for at least 90 days90 days

verified by chart notes and/or pharmacy paid claims

Laboratory criteria: Recent (within 30 days) labs documenting total urine protein ≥ 1 g/day OR urine protein-to-creatinine ratio ≥ 1.0 g/g AND eGFR ≥ 30 mL/min/1.73 m2urine protein ≥1 g/day OR UPCR ≥1.0 g/g; eGFR ≥30 mL/min/1.73 m2

must submit lab results taken within the last 30 days

Safety monitoring and pregnancy: Provider will measure liver aminotransferases and total bilirubin prior to starting Filspari and will assess ALT/AST regularly during treatment; pregnancy test prior to initiation for members with child-bearing potential and use of effective contraception during treatment

attestation required

Concomitant medications and discontinuations: Member will discontinue all ACE inhibitors and ARBs while using sparsentan and will avoid concomitant therapy with RAAS inhibitors, endothelin receptor antagonists, aliskiren, strong CYP3A inhibitors or inducers, histamine H2 receptor antagonists, proton pump inhibitors, and sensitive substrates of P-gp and BCRP

attestation required

Prior therapy

Budesonide trial failure: Unsuccessful 3-month trial of oral generic budesonide EC capsules (documentation of therapy failure required)3 months
chart notes or pharmacy claims required
Budesonide intolerance/contraindication: Intolerance or hypersensitivity to oral generic budesonide EC capsules or an FDA-labeled contraindication to budesonide (documentation required)
documentation required
Not using listed complementary therapies: Member is NOT using concomitant therapy with Tarpeyo, Filspari, Fabhalta, Vanrafia, Voyxact, or other complement inhibitor therapies (e.g., Empaveli, Soliris, Ultomiris, Voydeya)

Dosing and quantity limit: Recommended dosing: 200 mg once daily for 14 days, then increase to 400 mg once daily if tolerated; quantity limit 1 tablet per day

from drug information section

inv-02: Reauthorization — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Continued criteria: Member continues to meet all initial authorization criteria

Reauthorization: 12 months

Response to therapy: Member has reduction in proteinuria from baseline after initial approval, and reduction or stabilization in proteinuria after subsequent approvals (current lab test results must be submitted)

current lab documentation required

Renal function and adverse effects: Current labs within the last 30 days document eGFR ≥ 30 mL/min/1.73 m2 AND member has NOT experienced treatment-restricting adverse effects (e.g., hepatotoxicity, acute kidney injury, severe hypotension, hyperkalemia)eGFR ≥30 mL/min/1.73 m2

labs within 30 days required

Approval will not be granted under the prior therapy clause for members who are currently using any of the listed therapies. Specifically, members who are using Tarpeyo®, Filspari®, Fabhalta®, Vanrafia™, Voyxact®, or other complement inhibitor therapies are excluded from approval unless they meet alternate criteria documented on the request form. Documentation verifying current use or discontinuation of these agents must be provided to support the prior therapy determination.

Initial Authorization Criteria and Dosing

inv-14: Initial Therapy — initial authorization criteria and dosing

Initial authorization criteria and dosing

Dosing: Recommended dosing: Oral: initial 200 mg once daily for 14 days; on day 15 increase to 400 mg once daily if tolerated; quantity limit 1 tablet per day

from drug information section

Age and provider: Member is 18 years of age or older AND prescriber is a nephrologist

Initial Authorization: 6 months

Reauthorization / Continuation Therapy

inv-15: Reauthorization / Continuation Therapy — reauthorization requirements

Reauthorization requirements

Maintain initial criteria: Member continues to meet all initial authorization criteria

Proteinuria improvement: Member has reduction in proteinuria from baseline after initial approval; reduction or stabilization for subsequent approvals (current lab test results must be submitted)

current lab results required

No treatment-limiting AEs: Member has not experienced hepatotoxicity, acute kidney injury, severe hypotension, or hyperkalemia

Coding and Clinical Thresholds

No specific codes listed on formmixed

No codes listed

inv-05: Proteinuria — Total urine protein ≥ 1 g/day OR urine protein-to-creatinine ratio ≥ 1.0 g/g

Proteinuria thresholdTotal urine protein ≥ 1 g/day OR urine protein-to-creatinine ratio ≥ 1.0 g/g

Lab timingResults must be taken within the last 30 days and submitted with the request

PurposeRequired to meet initial and reauthorization laboratory criteria for Filspari approval

inv-06: eGFR — eGFR ≥ 30 mL/min/1.73 m2

eGFR requirementeGFR ≥ 30 mL/min/1.73 m2

Lab timingeGFR must be documented on lab results obtained within the last 30 days

ApplicabilityRequired for both initial authorization and reauthorization documentation

Prescriber and Specialty Pharmacy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The prescribing physician must complete, sign (handwritten signature; preprinted stamps not valid), and submit the Pharmacy Prior Authorization/Step-Edit Request form to AvMed (fax: 1-305-671-0200). Incomplete, incorrect, or illegible forms — including missing phone/fax numbers — may delay processing or result in denial.

Fax: 1-305-671-0200
Prescriber signature required (no preprinted stamps)
Samples do not satisfy prior authorization/step-edit criteria

Step Therapy

Step Therapy / Prior Therapy Requirement

A trial of specified therapy or documentation of intolerance/contraindication is required prior to approval. Member must meet ONE of the step-therapy options (e.g., unsuccessful 3-month trial of generic budesonide EC with supporting chart notes or labs, or documented intolerance/hypersensitivity/contraindication to budesonide). Previous therapies will be verified via pharmacy paid claims or submitted chart notes.

Unsuccessful 3-month trial of oral generic budesonide EC (chart notes/labs required)
Intolerance/hypersensitivity or FDA contraindication to budesonide (documentation required)
Samples cannot be used to satisfy step-edit

Documentation Required

Required Attachments and Clinical Documentation

Prescriber must provide required attachments and clinical documentation with the PA form. Include member and prescriber details (member name, AvMed #, DOB; prescriber name, NPI, office contact, phone, fax), diagnosis and ICD code, dosing schedule, weight and date obtained (if applicable), recommended dosage, length of therapy, and quantity requested. For initial requests, submit labs and chart notes to support each checked clinical criterion.

Member identifiers: name, AvMed #, DOB
Prescriber identifiers: name, NPI, signature, phone, fax
Drug details: name/form/strength, dosing schedule, length of therapy, quantity limit
Diagnosis and ICD code; weight (if applicable) and date obtained
Recommended dosage and therapy length

Denial Risk

Form Completeness — Risk of Delay or Denial

Form completeness is critical. If the PA form is incomplete, incorrect, or illegible (including missing required contact information or signature), authorization may be delayed or denied.

Hand-signed prescriber signature required; preprinted stamps not valid
Ensure phone and fax numbers are included and legible
Incomplete/illegible forms can delay or result in denial

Denial Risk

Missing Supporting Documentation — Denial Risk

Failure to submit required supporting documentation will risk denial. Provide recent labs (within last 30 days) as specified: urine protein (≥1 g/day or UPCR ≥1.0 g/g), eGFR (≥30 mL/min/1.73 m2), liver aminotransferases and total bilirubin baseline/ongoing monitoring, and pregnancy test for members of child-bearing potential. Also include chart notes or pharmacy claims verifying RAAS inhibitor therapy for ≥90 days and prior therapy trials.

Labs within 30 days: urine protein or UPCR, eGFR ≥30 mL/min/1.73 m2
Baseline and ongoing LFTs (ALT/AST) and total bilirubin
Pregnancy test and contraception attestation for those with child-bearing potential
Evidence of stable, maximally tolerated RAAS inhibitor therapy for ≥90 days (chart notes or paid claims)
Documentation of prior therapy trials or intolerance (chart notes or pharmacy claims)

Step Therapy Requirements

Step	Requirement	Documentation
1	Member must have had an unsuccessful 3‑month trial of oral generic budesonide EC capsules	Chart notes or lab test results confirming therapy failure must be submitted
2	Intolerance, hypersensitivity, or FDA‑labeled contraindication to oral generic budesonide EC capsules	Documentation of intolerance, hypersensitivity, or contraindication must be submitted
3	Member is not using concomitant therapy with Tarpeyo, Filspari, Fabhalta, Vanrafia, Voyxact, or other complement inhibitor therapies	Verification via chart notes or pharmacy paid claims; attestations on PA form

Quantity Limits and Dispensing

inv-17: Filspari (sparsentan) — quantity limit: 1 tablet/day

Quantity limit1 tablet per day

Recommended dosingInitial: 200 mg once daily for 14 days; on day 15 increase to 400 mg once daily if tolerated

Authorization noteQuantity limit aligns with recommended dosing and is enforced on the PA form

Dispensing Site and Specialty Pharmacy

Note

Specialty pharmacy — medication provided by Proprium Rx

This medication is dispensed via a specialty pharmacy—Proprium Rx—so prescriptions will be processed through that specialty pharmacy.

Use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Background

Filspari (sparsentan) is a dual endothelin and angiotensin receptor antagonist indicated for biopsy‑proven primary immunoglobulin A nephropathy (IgAN) at risk of rapid progression. Treatment initiation and continuation require baseline and on‑treatment monitoring because of potential risks including hepatotoxicity, hypotension, hyperkalemia, and changes in renal function. Prior authorization is required and the form documents step‑therapy requirements (for example, a three‑month trial of generic oral budesonide EC capsules unless intolerant or contraindicated), laboratory thresholds (including eGFR ≥ 30 mL/min/1.73 m2 and proteinuria criteria), and the need to submit supporting documentation such as recent labs and chart notes.

Definitions

inv-13: Indicated condition — Biopsy-proven, primary immunoglobulin A nephropathy (IgAN) with risk of rapid progression

IndicationBiopsy-proven, primary immunoglobulin A nephropathy (IgAN) with risk of rapid disease progression

Age and provider requirementMember must be ≥ 18 years of age and prescriber must be a nephrologist

Exclusions/related therapiesPrior or concomitant use of listed complement inhibitors or certain agents may affect approval under prior therapy criteria