CurrentMass General Brigham Health PlanPolicy N/A

Filspari (sparsentan) coverage for IgA nephropathy

Defines prior authorization, specialty pharmacy routing, initial and renewal coverage criteria for sparsentan (Filspari) for adults with primary IgA nephropathy within Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFilspari (sparsentan) coverage for IgA nephropathy

Policy CodePolicy N/A

Change TypeRevised reauthorization criteria

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of biopsy-confirmed primary IgA nephropathy, quantitative proteinuria (24-hour or UPCR), and trial/intolerance to a maximally tolerated RAS inhibitor for at least 3 months.

SourceLink

POLICY UPDATE CHANGES

Updated reauthorization criteria to require documentation of benefit and removed requirement that the member is intolerant to glucocorticoids from initial criteria.

12 monthsApproval duration

>=1 g/dayProteinuria threshold

Adults with IgANIndication population

>=3 monthsPrior RAS trial

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Initial Therapy

Covered when ALL of the following are met

Initial approval requirements: 1) Documented diagnosis of primary immunoglobulin A nephropathy confirmed by kidney biopsy; 2) Documented proteinuria ≥1 g/day or UPCR >0.8 g/g based on 24-hour urine collection; 3) Member has had intolerance, adverse effect, or contraindication to a maximally tolerated renin-angiotensin system (RAS) inhibitor (ACE inhibitor or ARB) for at least 3 months;

The policy allows authorization for members new to the plan who are already receiving treatment within the past 90 days as an alternative pathway.

Continuation of Therapy

Requests for reauthorization will be approved when the following criteria are met

Evidence of clinical response: Documentation demonstrating a positive clinical response to therapy as evidenced by decreased levels of proteinuria from baseline on a 24-hour urine collection OR decrease in UPCR from baseline based on 24-hour urine collection.decrease from baseline

Approvals (initial and reauthorization) will be granted for 12 months.

Authorization exclusions: members new to the plan who are not currently receiving the medication within the past 90 days do not qualify for the 'new to plan' exception. The policy permits an exception only when the member is already receiving the requested medication within the past 90 days; products obtained as samples or through manufacturer patient assistance programs are excluded from this allowance.

Use of Filspari (sparsentan) is limited to adults with biopsy-confirmed primary immunoglobulin A (IgA) nephropathy who meet the proteinuria and RAS-inhibitor trial requirements. Indications that do not meet these requirements — for example, diagnoses other than primary biopsy-confirmed IgAN, failure to document proteinuria ≥1 g/day or UPCR >0.8 g/g based on a 24-hour urine collection, or lack of a documented intolerance/contraindication to a maximally tolerated renin-angiotensin system (ACEI or ARB) trial of at least 3 months — are not supported by this policy.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Specialty medication routing: this agent is designated specialty and must be dispensed through a contracted specialty pharmacy.

Prior authorization required for Commercial/Exchange plans
Specialty medication — must be filled at contracted specialty pharmacy (Medical and Specialty Medications contact: Phone: 877-519-1908; Fax: 855-540-3693). Non-specialty contact: Phone: 800-711-4555; Fax: 844-403-1029.

Step Therapy

Step Therapy Note

No formal multi-step therapy sequence beyond requirement to try and have intolerance/adverse effect/contraindication to maximally tolerated RAS inhibitor. Step therapy does not mandate a specific ordered sequence of multiple medications.

Step note: Member must have intolerance, adverse effect, or contraindication to maximally tolerated renin–angiotensin system (RAS) inhibitor (ACEI or ARB) for ≥ 3 months before approval.

Documentation Required

Required Documentation

Submit documentation confirming diagnosis and baseline disease severity. Required items include kidney biopsy confirming primary IgA nephropathy and quantitative proteinuria measurement; for continuations submit evidence of clinical response.

Kidney biopsy confirming primary immunoglobulin A (IgA) nephropathy
Quantitative proteinuria: 24‑hour urine protein (g/day) showing proteinuria ≥1 g/day or UPCR >0.8 g/g (based on 24‑hour collection)
Documentation of intolerance/adverse effect/contraindication to maximally tolerated RAS inhibitor (ACEI or ARB) for at least 3 months
For continuation: documentation of positive clinical response — decreased proteinuria from baseline on 24‑hour urine collection or decreased UPCR from baseline (24‑hour collection)
For members new to the plan: proof of receipt of the medication within the past 90 days (excluding sample or manufacturer patient assistance program supplies)

Denial Risk

Triggers for Denial

Authorization may be denied when criteria are not met, when member is new to plan and has not recently received the medication, or when initiation occurs without required documentation or failure/intolerance to RAS inhibitor.

Denial triggers include: member new to plan without evidence of receiving the medication within the past 90 days (excluding samples and manufacturer assistance programs)
Initiation without required documentation (kidney biopsy, quantitative proteinuria, RAS inhibitor intolerance documentation)
Failure to document intolerance/adverse effect/contraindication to a maximally tolerated ACEI or ARB for ≥ 3 months
Requests that do not demonstrate meeting all approval criteria or lack evidence of clinical response for continuation requests

Definitions and Key Clinical Thresholds

inv-12: Proteinuria criteria

Documented proteinuriaProteinuria ≥1 g/day based on 24-hour urine collection

UPCR criterionUPCR >0.8 g/g based on 24-hour urine collection

Measurement methodQuantification must be from a 24-hour urine collection

inv-13: Prior RAS inhibitor requirement

Required trialMust have trialed a maximally tolerated renin-angiotensin system (RAS) inhibitor (ACEI or ARB) for at least 3 months

Alternative pathwayAuthorization may be granted for members new to the plan currently receiving the medication within the past 90 days (see policy for exclusions)

Intolerance/contraindicationIf member has intolerance, adverse effect, or contraindication to RAS inhibitor, this satisfies the requirement

Policy Summary

PayerMass General Brigham Health Plan

PolicyFilspari (sparsentan) coverage for IgA nephropathy

Policy CodePolicy N/A

Change TypeRevised reauthorization criteria

Effective DateMar 1, 2025

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Filspari (sparsentan) coverage for IgA nephropathy

Coverage Criteria for Filspari (sparsentan)

Billing and Coding

Provider Actions and Authorization Requirements

Definitions and Key Clinical Thresholds

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