CurrentAnthemPolicy CC-0296

Voyxact (sibeprenlimab-szsi) for primary IgA nephropathy — coverage and prior authorization criteria

Policy governs medical-benefit coverage and prior authorization criteria for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) and specifies approval conditions, quantity limits, and coding. Affects providers requesting Voyxact under Anthem clinical policy CC-0296.

Policy Summary

PayerAnthem

PolicyVoyxact (sibeprenlimab-szsi) for primary IgA nephropathy — coverage and prior authorization criteria

Policy CodePolicy CC-0296

Change TypeMaterial clinical and administrative updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of biopsy-verified primary IgAN, trial of maximally tolerated ACE inhibitor or ARB (unless contraindicated), baseline eGFR and proteinuria, and plan for concomitant ACE inhibitor or ARB use.

SourceLink

POLICY UPDATE CHANGES

New clinical criteria and quantity limit for Voyxact were added.

eGFR ≥ 30minimum renal function for eligibility

UPCR ≥ 0.75proteinuria entry thresholds

6 moinitial approval

1 yrcontinuation approval

1 syringe/4 wks

Policy Summary

PayerAnthem

PolicyVoyxact (sibeprenlimab-szsi) for primary IgA nephropathy — coverage and prior authorization criteria

Policy CodePolicy CC-0296

Change TypeMaterial clinical and administrative updates

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Coverage Criteria for Voyxact (sibeprenlimab-szsi)

Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria

Diagnosis: Patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) verified by kidney biopsy.
RAS inhibitor trial and concomitant use: Patient has had a trial of maximally tolerated ACE inhibitor or ARB unless contraindicated or not tolerated; plan to take Voyxact in combination with an ACE inhibitor or ARB unless contraindicated.
Concomitant ACE inhibitor or ARB required unless contraindicated.
Proteinuria threshold
- UPCR: Urine protein-to-creatinine ratio (UPCR) ≥ 0.75 g/g.
- 24-hour urine protein: Urine protein ≥ 1 g/day.
Renal function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2.
Authorization and quantity note: Prior authorization is required; initial approval may be granted for 6 months. Quantity limit: 1 prefilled syringe (400 mg/2 mL) per 4 weeks.

Continuation Therapy

Covered when ALL of the following are met:

Continuation approval criteria

Proteinuria response: There is documentation of clinically significant reduction in proteinuria compared with baseline while on therapy.
Ongoing concomitant RAS inhibitor: Documentation is provided that the individual will be taking Voyxact in combination with an ACE inhibitor or ARB unless contraindicated or not tolerated.
Authorization duration: When criteria are met, continuation approvals may be granted for up to 1 year.

Voyxact (sibeprenlimab-szsi) may not be approved for use in combination with Tarpeyo (budesonide delayed release) or Fabhalta (iptacopan).

Requests that do not meet all initial coverage criteria will be considered not medically necessary. Examples include: absence of a kidney biopsy verifying primary IgA nephropathy; proteinuria below policy thresholds (UPCR < 0.75 g/g and urine protein < 1 g/day); estimated glomerular filtration rate below the minimum (eGFR < 30 mL/min/1.73 m2); or lack of documentation of a trial of maximally tolerated ACE inhibitor or ARB and plan for concomitant ACE inhibitor or ARB use when not contraindicated.

Coding — HCPCS and Diagnosis Codes

HCPCSHCPCS

C9399	Unclassified drugs or biologicals [when specified as Voyxact (sibeprenlimab-szsi)]
J3590	Unclassified biologics [when specified as Voyxact (sibeprenlimab-szsi)]

ICD-10 DiagnosisICD-10

N02.B1-N02.B9

ICD-10 codes listed (recurrent and persistent immunoglobulin A nephropathy)

inv-07: UPCR threshold

UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 0.75 g/g

ContextOne of two proteinuria entry criteria required for initial approval of Voyxact

Measurement useUsed to determine protein excretion for eligibility in IgAN treatment

inv-08: Urine protein (24-hour) threshold

24‑hour urine protein thresholdUrine protein (24‑hour) ≥ 1 g/day

ContextAlternative proteinuria entry criterion for initial approval of Voyxact

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization and Quantity Limit

Prior authorization is required for Voyxact (sibeprenlimab-szsi). Initial approval is limited to 6 months; continuation approvals may be granted for 1 year. Quantity limit: 1 syringe (400 mg) per 4 weeks.

Prior authorization required
Initial approval: up to 6 months
Continuation approval: up to 1 year
Quantity limit: 1 syringe (400 mg) per 4 weeks

Documentation Required

Concomitant RAS Inhibitor Requirement

Patients must have a trial of maximally tolerated angiotensin‑converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) unless contraindicated or not tolerated. Voyxact should be used in combination with ongoing RAS blockade (ACE inhibitor or ARB) when tolerated.

Background and Drug Information

Voyxact (sibeprenlimab-szsi) is an APRIL (a proliferation-inducing ligand) blocker granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for progression. Approval was supported by a randomized, double-blind trial (pivotal population described in the policy) demonstrating a substantial reduction in proteinuria versus placebo. Voyxact is intended to be used in conjunction with renin–angiotensin system blockade (ACE inhibitor or ARB) unless contraindicated; continued approval may depend on confirmatory studies.

Definitions and Key Measures

inv-16: IgAN definition

DefinitionPrimary immunoglobulin A nephropathy (IgAN): a glomerular disease characterized by IgA‑dominant immune complex deposition and often presenting with proteinuria and variable declines in renal function

Diagnostic confirmationDiagnosis must be verified by kidney biopsy for coverage determination

Indication contextVoyxact is indicated to reduce proteinuria in adults with primary IgAN at risk for disease progression

inv-17: UPCR definition

DefinitionUrine protein‑to‑creatinine ratio (UPCR): a laboratory measure of protein excretion used to assess proteinuria

Policy thresholdPolicy requires UPCR ≥ 0.75 g/g for eligibility (one of two acceptable proteinuria criteria)

Documentation Required

Required Documentation for Initial Request

For initial requests provide the following documentation: kidney biopsy verification of primary IgA nephropathy (IgAN); documentation of trial of maximally tolerated ACE inhibitor or ARB or documentation of contraindication/intolerance; baseline proteinuria measurement (UPCR in g/g or 24‑hour urine protein in g/day) showing UPCR ≥ 0.75 g/g or urine protein ≥ 1 g/day; baseline estimated glomerular filtration rate (eGFR) showing ≥ 30 mL/min/1.73 m2; plan showing concomitant use of ACE inhibitor or ARB unless contraindicated; and any other relevant clinical records supporting diagnosis and prior therapies.

Biopsy‑verified diagnosis of primary IgA nephropathy (IgAN)
Documentation of trial of maximally tolerated ACE inhibitor or ARB, or reason ACE/ARB not tolerated/contraindicated
Baseline proteinuria: UPCR (g/g) or 24‑hour urine protein (g/day) meeting criteria
Baseline eGFR (mL/min/1.73 m2) showing ≥ 30
Plan for concomitant ACE inhibitor or ARB unless contraindicated
Other supporting clinical records (progress notes, labs, prior therapy documentation)