ModifiedMass General Brigham Health PlanPolicy N/A

Filspari (sparsentan)

Prior authorization policy for Filspari (sparsentan) under the pharmacy benefit for Commercial/Exchange members; defines initial and continuation criteria, quantity limits, specialty pharmacy requirement, and required documentation.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFilspari (sparsentan)

Policy CodePolicy N/A

Change TypeMaterial clinical and administrative updates (eGFR threshold, risk-for-progression requirement, quantity limits, specialty)

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization is required; submit documentation per initial or continuation criteria to obtain approval.

SourceLink

POLICY UPDATE CHANGES

Added minimum eGFR (>= 30 mL/min/1.73m2) to initial criteria.

Required that member is 'at risk for disease progression' in initial criteria.

Added quantity limits (1 tablet per day) and specialty pharmacy requirement.

Updated verbiage for ACEI/ARB trial requirement to clarify maximally tolerated dose.

Removed minimum proteinuria level requirement from initial criteria (replaced with 'at risk for disease progression').

Updated reauthorization criteria to require documentation of benefit (positive clinical response).

Removed documentation requirements from initial criteria (administrative wording changes).

12 monthsApproval Duration

1/dayQuantity Limit

>=30Minimum eGFR (mL/min/1.73m2)

>=3 monthsRequired RAS inhibitor trial

Coverage Summary

Scope: Prior authorization policy for Filspari (sparsentan) under the Commercial/Exchange pharmacy benefit. Coverage is for specialty-dispensed fills only (must be filled at a contracted specialty pharmacy). Approval decisions follow defined initial and continuation criteria. Quantity limit: 1 tablet per day. Approval duration for initial and reauthorization requests: 12 months.

Key thresholds and quick facts

Approval duration12 months

Quantity limit1 tablet per day

Minimum eGFR>= 30 mL/min/1.73m2

Required RAS inhibitor trial>= 3 months at maximally tolerated dose (unless intolerance/adverse effect/contraindication)

Specialty pharmacy requirementMust be filled at a contracted specialty pharmacy

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy
Member is at risk for disease progression
Estimated glomerular filtration rate (eGFR)>= 30 mL/min/1.73m2
Exact threshold stated as >= 30 mL/min/1.73m2
Member has received at least a 3-month trial with a renin-angiotensin system (RAS) inhibitor (e.g., ACEI or ARB) at a maximally tolerated dose, unless the member has had an intolerance, adverse effect, or contraindication

Continuation Therapy Criteria

Continuation of Therapy / Reauthorization

Requests for reauthorization will be approved when ALL of the following are met:

ALL of the following

Evidence of positive clinical response (one required): Decreased levels of proteinuria from baseline on a 24-hour urine collection
Evidence of positive clinical response (one required): Decrease in urine protein-to-creatinine ratio (UPCR) from baseline based on 24-hour urine collection

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Filspari. Submit documentation that meets the policy's initial or continuation criteria to obtain approval.

Documentation Required

Diagnosis and Biopsy Documentation

Provide documentation confirming diagnosis of primary immunoglobulin A nephropathy (IgAN) by kidney biopsy for initial authorization.

Applicable Codes & Program Rules

Benefit / Programmixed

Specialty pharmacy fill requirement

Medication must be filled at a contracted specialty pharmacy

Clinical Evidence & References

Evidence: Prescribing information — Travere Therapeutics, August 2025; Key trial — PROTECT phase 3 trial (Rovin et al., Lancet 2023) comparing sparsentan versus irbesartan in IgA nephropathy; Guideline — KDIGO 2021 Clinical Practice Guideline for Management of Glomerular Diseases.

Background & Definitions

Background: Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The policy applies to the Commercial/Exchange pharmacy benefit and requires dispensing through a contracted specialty pharmacy.

Term	Definition
RAS inhibitor	Renin-angiotensin system inhibitor, e.g., angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB).
UPCR	Urine protein-to-creatinine ratio.

Revision History

06/14/2023review

Reviewed at June P&T; policy effective 08/01/2023.

11/15/2023review

Reviewed at Nov P&T; no clinical changes.

12/11/2024revision

Updated wording: 'medical records' changed to 'documentation'; removed glucocorticoid intolerance requirement from initial criteria; reauthorization criteria updated to require documentation of benefit. (Effective 03/01/2025)

Policy Summary

PayerMass General Brigham Health Plan

PolicyFilspari (sparsentan)

Policy CodePolicy N/A

Change TypeMaterial clinical and administrative updates (eGFR threshold, risk-for-progression requirement, quantity limits, specialty)

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization is required; submit documentation per initial or continuation criteria to obtain approval.

SourceLink

On This Page

RAS inhibitor trial duration at maximally tolerated dose unless intolerance/adverse effect/contraindication

New to plan documentation alternative: If member is new to the plan (coverage effective date <= 90 days), submission of medical records documenting that the member is currently receiving treatment with requested drug (excluding samples or manufacturer's patient assistance program supply) may be submitted in lieu of meeting other criteria

Limitations

ALL of the following

Approval length: Initial approvals and reauthorizations will be granted for 12 months12 months
Quantity limit: Filspari tablet - 1 tablet per day1 tablet/day
Specialty pharmacy: This medication is designated specialty and must be filled at a contracted specialty pharmacy

Documentation Required

eGFR Documentation

Submit a recent estimated glomerular filtration rate (eGFR) documenting a value greater than or equal to 30 mL/min/1.73 m2 for initial authorization.

Documentation Required

RAS Inhibitor Trial Documentation

Document a trial of a renin–angiotensin system (RAS) inhibitor (e.g., ACEI or ARB) of at least 3 months at the maximally tolerated dose, or provide documentation of intolerance, adverse effect, or contraindication to RAS inhibition.

Documentation Required

Continuation: Proof of Clinical Response

For reauthorization, submit medical records showing a positive clinical response to therapy demonstrated by either decreased proteinuria from baseline on a 24‑hour urine collection or a decrease in urine protein‑to‑creatinine ratio (UPCR) from baseline based on a 24‑hour urine collection.

Billing Rule

Quantity Limit

Quantity limit: Filspari tablets are limited to 1 tablet per day. Ensure prescriptions adhere to this limit.

Billing Rule

Specialty Pharmacy Dispense

This medication is designated specialty and must be dispensed through a contracted specialty pharmacy per the policy.

03/01/2025clarification

Reauthorization criteria clarified to require documentation of benefit (positive clinical response) such as decreased proteinuria or decreased UPCR from baseline. (Effective 03/01/2025)

08/13/2025administrative_revision

Removed documentation requirements from initial criteria. (Change noted prior to quantity limit addition)

11/01/2025material_change

Quantity limits added: Filspari tablet limited to 1 tablet per day; specialty designation requiring fill at contracted specialty pharmacy noted. (Effective 11/01/2025).

01/01/2026wording_update

Updated verbiage clarifying ACEI/ARB (RAS inhibitor) trial requirement to specify trial at maximally tolerated dose unless intolerance/adverse effect/contraindication. (Effective 01/01/2026)

02/11/2026material_change

Removed prior minimum proteinuria level requirement and replaced with requirement that member is 'at risk for disease progression'; added minimum eGFR threshold (>= 30 mL/min/1.73m2) to initial criteria. (Effective 05/01/2026)

05/01/2026effective_dateLatest

Policy effective incorporating February 11, 2026 updates: initial criteria require diagnosis by kidney biopsy, member at risk for disease progression, eGFR >= 30 mL/min/1.73m2, and ≥3-month RAS inhibitor trial at maximally tolerated dose; quantity limit and specialty pharmacy requirements in place.