ModifiedCignaPolicy CNF969

Nephrology – Voyxact Prior Authorization Policy - (CNF969)

Prior authorization policy for Voyxact (sibeprenlimab-szsi) subcutaneous injection for treatment of primary immunoglobulin A nephropathy (IgAN) in adults, including clinical criteria for initial and continued therapy, exclusions, prescribing specialty requirement, and approval duration.

Policy Summary

PayerCigna

PolicyNephrology – Voyxact Prior Authorization Policy - (CNF969)

Policy CodePolicy CNF969

Change TypeDefinition and duration revisions

Effective Date

Next Review Date

Key ActionPrior authorization is required and prescribers must document biopsy-confirmed IgAN, age, eGFR, proteinuria/UPCR, prior ACEI/ARB therapy, ≥3 months optimized supportive care, and response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

New Policy created with review date 12/10/2025.

Approval duration changed to 1 year for both initial therapy and patients currently receiving Voyxact.

High risk of disease progression definition modified to require UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day (was UPCR ≥ 0.8 g/g or proteinuria ≥ 0.5 g/day).

1Covered Indication (IgAN)

1Approval Duration (years)

≥18Minimum Age

≥30Minimum eGFR (mL/min/1.73 m2)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization policy for Voyxact (sibeprenlimab-szsi) subcutaneous injection for treatment of primary immunoglobulin A nephropathy (IgAN) in adults, including clinical criteria for initial and continued therapy, exclusions, prescribing specialty requirement, and approval duration.

Approval duration: 1 year for both initial therapy and for patients currently receiving Voyxact.

Indication: FDA accelerated approval for Voyxact to reduce proteinuria in adults with primary IgAN who are at risk of rapid progression.

Note: Continued approval may depend on verification of clinical benefit in confirmatory trials, and the long-term effect of Voyxact on slowing kidney function decline has not been established.

Quick Facts / Thresholds

Covered IndicationPrimary immunoglobulin A nephropathy (IgAN) — reduce proteinuria in adults at risk of rapid progression

Approval Duration1 year (initial therapy and patients currently receiving Voyxact)

Minimum Age≥ 18 years

Minimum eGFR≥ 30 mL/min/1.73 m2

Proteinuria / UPCR thresholdsProteinuria ≥ 0.5 g/day OR UPCR ≥ 0.5 g/g

Minimum prior ACEI/ARB duration≥ 12 weeks on maximum or maximally tolerated dose

Optimized supportive care duration≥ 3 months (blood pressure management, lifestyle modification, cardiovascular risk modification)

Policy numberCNF969

StatusMODIFIED

FDA-Approved Indication — Initial and Continuation Criteria

FDA-Approved Indication - Primary Immunoglobulin A Nephropathy

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
The diagnosis has been confirmed by biopsy
Patient is at high risk of disease progression
- Proteinuria threshold
  - Proteinuria ≥ 0.5 g/day≥ 0.5 g/day

Conditions Not Covered / Exclusions

Conditions Not Covered

Voyxact is considered not medically necessary for ANY other use(s)

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Voyxact. All approvals are provided for the duration noted; approvals for Voyxact are provided for 1 year where specified.

Prior Authorization

Prescriber specialty requirement

Voyxact must be prescribed by or in consultation with a nephrologist.

Applicable Codes

Drug / HCPCS / NDCmixed

No codes listed

Clinical Evidence

51%Relative UPCR reduction vs placebo at Month 9 (P<0.0001)

50%Geometric LS mean UPCR percent change at Month 9 (Voyxact)

2%Geometric LS mean UPCR percent change at Month 9 (placebo)

34.3% vs 12.7%Proteinuria remission at Month 12 (Voyxact vs placebo, exploratory)

Supporting evidence:

Phase III VISONARY interim analysis — Geometric least squares mean percent change in UPCR at Month 9: 50% reduction with Voyxact vs 2% with placebo, corresponding to a 51% relative reduction (P < 0.0001).

Remission of proteinuria at Month 12 (exploratory) — 34.3% Voyxact vs 12.7% placebo.

Regulatory status: Voyxact was approved under accelerated approval based on reduction of proteinuria. The long-term effect on kidney function decline has not been established and continued approval may be contingent on confirmatory trials.

Background & Definitions

Voyxact (sibeprenlimab-szsi) is an A Proliferation Inducing Ligand (APRIL) blocker indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression.

Voyxact was approved under accelerated approval based on reduction of proteinuria. It has not been established whether Voyxact slows kidney function decline over the long-term in patients with IgAN; continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Prior authorization is recommended for prescription benefit coverage of Voyxact, and approval requires the medication to be prescribed by or in consultation with a nephrologist.

Definitions:

High risk of disease progression: For this policy, defined as UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day plus prior ACEI or ARB maximal tolerated therapy for ≥ 12 weeks.

Optimized supportive care: Includes blood pressure management, lifestyle modification, and cardiovascular risk modification for ≥ 3 months.

Revision History

12/10/2025policy_created

New Policy created with review date 12/10/2025.

03/25/2026selected_revision

Selected Revision: Approval duration changed to 1 year for both initial therapy and patients currently receiving Voyxact.

04/22/2026early_annual_revisionLatest

Early Annual Revision: High risk of disease progression definition modified to require UPCR ≥ 0.5 g/g OR proteinuria ≥ 0.5 g/day (was UPCR ≥ 0.8 g/g or proteinuria ≥ 0.5 g/day).

Policy Summary

PayerCigna

PolicyNephrology – Voyxact Prior Authorization Policy - (CNF969)

Policy CodePolicy CNF969

Change TypeDefinition and duration revisions

Effective Date

Next Review Date

SourceLink

On This Page

Urine protein-to-creatinine ratio (UPCR) ≥ 0.5 g/g≥ 0.5 g/g

Prior therapy requirement

Patient has received or is currently receiving the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) for ≥ 12 weeks prior to starting Voyxact≥ 12 weeks
Patient has received or is currently receiving the maximum or maximally tolerated dose of an angiotensin receptor blocker (ARB) for ≥ 12 weeks prior to starting Voyxact≥ 12 weeks

According to the prescriber, patient has received ≥ 3 months of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification≥ 3 months

Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2≥ 30 mL/min/1.73 m2

The medication is prescribed by or in consultation with a nephrologist

B) Patient is Currently Receiving Voyxact

Patient is ≥ 18 years of age
The diagnosis has been confirmed by biopsy
According to the prescriber, patient has had a response to the requested medication
Examples of a response are a reduction in urine protein-to-creatinine ratio from baseline, reduction in proteinuria from baseline
Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2≥ 30 mL/min/1.73 m2
The medication is prescribed by or in consultation with a nephrologist

Documentation Required

Clinical documentation required

Prescriber must document the diagnosis and key clinical data to support medical necessity, including biopsy confirmation of IgA nephropathy, patient age, eGFR, proteinuria (24-hour) or UPCR values, prior ACEI/ARB therapy duration and dose tolerance, receipt of ≥ 3 months of optimized supportive care, and for continuation requests evidence of response to Voyxact.

Biopsy-confirmed diagnosis of IgA nephropathy
Patient age (≥ 18 years)
Estimated glomerular filtration rate (eGFR ≥ 30 mL/min/1.73 m2)
Proteinuria (≥ 0.5 g/day) or urine protein-to-creatinine ratio (UPCR ≥ 0.5 g/g)
Prior ACEI or ARB therapy at maximum or maximally tolerated dose for ≥ 12 weeks
Documentation of ≥ 3 months of optimized supportive care (blood pressure management, lifestyle modification, cardiovascular risk modification)
For patients currently receiving Voyxact: prescriber documentation of response to the medication

Denial Risk

Denial if not meeting criteria

Claims will be denied when billed for conditions not accompanied by covered codes under this policy or when the clinical criteria are not met.