CurrentCignaPolicy IP0788

Voyxact (sibeprenlimab) for primary IgA nephropathy

Cigna coverage policy for prior authorization, medical necessity criteria, and coverage stance for Voyxact (sibeprenlimab) in adults with biopsy‑confirmed primary IgA nephropathy (IgAN) at risk of rapid progression.

Policy Summary

PayerCigna

PolicyVoyxact (sibeprenlimab) for primary IgA nephropathy

Policy CodePolicy IP0788

Change TypeNew policy

Effective DateJun 1, 2026

Next Review DateApr 16, 2026

Key ActionObtain prior authorization and document biopsy‑confirmed IgAN, proteinuria/UPCR, prior maximized ACEI/ARB therapy (≥12 weeks), and supportive care before approval.

SourceLink

POLICY UPDATE CHANGES

New coverage policy established for Voyxact with FDA‑approved indication for primary IgA nephropathy.

1 yearinitial approval duration

≥18minimum age

≥30eGFR threshold

≥0.5 g/dayproteinuria threshold

≥12 wksprior RAS therapy

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Coverage Criteria for Voyxact (sibeprenlimab)

FDA‑Approved Indication — Initial Therapy

Approve for 1 year if the patient meets ALL of the following (A.i–vi):

Initial Therapy criteria: Patient is ≥ 18 years of age; diagnosis confirmed by biopsy [documentation required]; patient is at high risk of disease progression defined by BOTH: (a) patient meets ONE of the following: (1) proteinuria ≥ 0.5 g/day [documentation required] OR (2) urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g [documentation required]; AND (b) patient has received or is currently receiving the maximum or maximally tolerated dose of ONE of the following for ≥ 12 weeks prior to starting Voyxact: (1) angiotensin-converting enzyme inhibitor (ACEI) OR (2) angiotensin receptor blocker (ARB); patient has received ≥ 3 months of optimized supportive care (blood pressure management, lifestyle modification, and cardiovascular risk modification) per prescriber; estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2; and medication is prescribed by or on consultation with a nephrologist.see individual nodes

Documentation required for biopsy, proteinuria/UPCR, prior ACEI/ARB therapy, and supportive care

FDA‑Approved Indication — Currently Receiving Voyxact

Approve for 1 year if the patient meets ALL of the following (B.i–v):

Continuation therapy criteria: Patient is ≥ 18 years of age; diagnosis confirmed by biopsy [documentation required]; prescriber documents patient has had a response to Voyxact (examples include reduction in UPCR or reduction in proteinuria from baseline); estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2; and medication is prescribed by or on consultation with a nephrologist.response to therapy as per prescriber

Examples of response include reduction in UPCR or proteinuria from baseline

Voyxact (sibeprenlimab) for any indication other than primary IgA nephropathy (IgAN) is considered not medically necessary and is not covered under this policy.

Use of Voyxact outside of the FDA‑approved indication for adults with biopsy‑confirmed primary IgAN at risk of rapid progression is explicitly stated as not medically necessary and will not be authorized under this policy.

Clinical Thresholds and Coding Parameters

Proteinuria / UPCR — Coverage Thresholds

Proteinuria threshold (24-hr)Proteinuria ≥ 0.5 g/day (documentation required)

UPCR thresholdUrine protein-to-creatinine ratio ≥ 0.8 g/g (documentation required)

Alternative definitionsMeeting either the proteinuria or UPCR threshold qualifies as the proteinuric criterion for high risk

eGFR Threshold

eGFR minimum for coverageeGFR ≥ 30 mL/min/1.73 m2 (required)

Evidence sourceeGFR threshold applied for both initial and continuing therapy criteria

Clinical trial eligibility note

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Voyxact. All approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation and diagnosis of patients treated with Voyxact as well as the monitoring required for adverse events and long-term efficacy, Voyxact must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., a nephrologist).

Prior authorization required for Voyxact
Prescriber requirement: prescribed by or in consultation with a specialist (nephrologist)

Denial Risk

Billing and Claims — Denial Risk

Claims submitted for services that are not accompanied by covered diagnosis and/or procedure codes under this Coverage Policy will be denied as not covered. Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this policy. When billing, providers must use the most appropriate codes as of the effective date of the submission.

Policy Definitions

High Risk of Disease Progression — Definition

Definition of high riskProteinuria ≥ 0.5 g/day OR UPCR ≥ 0.8 g/g PLUS receipt of maximum or maximally tolerated ACEI or ARB for ≥ 12 weeks

Supportive care requirementPatient must have received ≥ 3 months of optimized supportive care (blood pressure management, lifestyle modification, cardiovascular risk modification)

Documentation requiredBiopsy confirmation, proteinuria/UPCR measurement, and records of prior maximized RAS therapy must be provided

Voyxact Indication

Indication summaryVoyxact (sibeprenlimab) indicated to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression (accelerated approval)

Age restrictionAdults ≥ 18 years of age

Background and Clinical Context

IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide and a leading cause of chronic kidney disease and kidney failure. Disease progression in IgAN is associated with hypertension and persistent proteinuria; reducing proteinuria (target 0.5 g/day, ideally 0.3 g/day) is a validated surrogate for improved kidney outcomes. Voyxact is an APRIL‑blocking therapy approved under accelerated approval to reduce proteinuria in adults with primary IgAN who are at risk of rapid progression, although its long‑term effects on preservation of kidney function have not yet been established.

Policy Revision History

2026-06-01Policy effectiveLatest

Policy created and became effective establishing coverage criteria for Voyxact (sibeprenlimab) for adults with biopsy‑confirmed primary IgA nephropathy at risk of rapid progression.

2026-04-16Policy review

Policy underwent initial review on 2026-04-16 prior to implementation as a new coverage policy for Voyxact.